Adderall

Name: Adderall

Side effects

Loss of appetite, weight loss, dry mouth, stomach upset/pain, nausea/vomiting, dizziness, headache, diarrhea, fever, nervousness, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor of any high results.Tell your doctor right away if you have any serious side effects, including: numbness/pain/skin color change/sensitivity to temperature in the fingers or toes, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts), uncontrolled movements, continuous chewing movements/teeth grinding, outbursts of words/sounds, change in sexual ability/desire, frequent/prolonged erections (in males).Get medical help right away if you have any very serious side effects, including: shortness of breath, chest/jaw/left arm pain, fainting, severe headache, fast/pounding/irregular heartbeat, seizures, swelling of the ankles/feet, extreme tiredness, blurred vision, weakness on one side of the body, slurred speech, confusion.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Warnings

Serious Cardiovascular Events

Sudden Death And Preexisting Structural Cardiac Abnormalities Or Other Serious Heart Problems

Children and Adolescents

Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug [see CONTRAINDICATIONS].

Adults

Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs [see CONTRAINDICATIONS].

Hypertension And Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see ADVERSE REACTIONS], and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see CONTRAINDICATIONS].

Assessing Cardiovascular Status In Patients Being Treated With Stimulant Medications

Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.

Psychiatric Adverse Events

Preexisting Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

Emergence Of New Psychotic Or Manic Symptoms

Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.

Aggression

Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.

Long-Term Suppression Of Growth

Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining weight as expected may need to have their treatment interrupted.

Seizures

There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in absence of seizures, and very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.

Peripheral Vasculopathy, Including Raynaud's Phenomenon

Stimulants, including Adderall®, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in postmarketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see DRUG INTERACTIONS]. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see CLINICAL PHARMACOLOGY]. The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to Adderall®. In these situations, consider an alternative nonserotonergic drug or an alternative drug that does not inhibit CYP2D6 [see DRUG INTERACTIONS].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of Adderall® with MAOI drugs is contraindicated [see CONTRAINDICATIONS].

Discontinue treatment with Adderall® and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of Adderall® with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Adderall® with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Uses for Adderall

Attention Deficit Hyperactivity Disorder

Used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD) (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction).a b c e

Can be used for ADHD in pediatric (children, adolescents) as well as adult patients.d e

Almost all studies comparing behavioral therapy versus stimulants alone have shown a much stronger therapeutic effect from stimulants than from behavioral therapy, and stimulants (e.g., amphetamines, methylphenidate) remain the drugs of choice for the management of ADHD.d e

Drug therapy is not indicated in all patients with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed.b e

Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity and duration of symptoms and should not depend solely on one or more behavioral characteristics.b c e

Not recommended for ADHD symptoms associated with acute stress reactions.b

Narcolepsy

Used as a stimulant to reduce daytime sleepiness in the management of narcolepsy.a b

Amphetamines remain the mainstay of treatment for narcolepsy based on a long record of clinical experience.f

Tolerance to the clinical effects may develop with long-term therapy, particularly at high dosages.f

Exogenous Obesity

Has been used as an adjunct to caloric restriction and behavioral modification in the short-term treatment of exogenous obesity†.d However, because of the limited efficacy (short-lived) and risk of abuse, such use no longer is included in the FDA-approved labelinga c and is discouraged.d

The anorexigenic effect appears to be temporary, seldom lasting more than a few weeks, and tolerance may occur.b

Obesity usually is a chronic disease, and short-term or intermittent therapy with anorexigenic drugs is unlikely to maintain a long-term benefit.b

Adderall Dosage and Administration

Administration

Oral Administration

Conventional Tablets

Administer initial dose on awakening.a b When daily dosage is administered in 2 or 3 divided doses, administer the doses at intervals of 4–6 hours.a b Because of potential for insomnia, avoid administering doses in the late evening.a

Extended-release Capsules

Administer on awakening.c Because of potential for insomnia, avoid administering in the afternoon.c

Administer capsules with or without food;c capsules may be swallowed intact or the entire contents of a capsule(s) may be sprinkled on a small amount of applesauce immediately prior to administration.b c Do not subdivide the capsule contents.b c Do not chew or crush the pellets contained in the capsules and do not store the sprinkle/food mixture for later use.b c

Dosage

Fixed-combination extended-release capsules containing various salts of amphetamine and dextroamphetamine can be substituted for their respective conventional short-acting preparations if less-frequent daily dosing is desirable.b c

Dosage of fixed-combination preparations containing various salts of amphetamine and dextroamphetamine is expressed as total amphetamine base equivalence.a b c

Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.a b c

When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.a b c

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Dosage titration usually requires 2–4 weeks.e

Conventional Tablets Oral

Dosing in pediatric patients may begin with once-daily administration in the early morning, adding a noon dose if the effect does not last throughout the school day.e Increasing the morning dose may extend its duration.e A third dose may be added at around 4 p.m. if necessary.e

Children 3–5 years of age: Initially, 2.5 mg daily; the daily dosage is increased in 2.5-mg increments at weekly intervals until the optimum response is attained.a b e

Children ≥6 years of age: Initially, 5 mg once or twice daily; the daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained.a b e Total daily dosage rarely should exceed 40 mg.a b e

Extended-release Capsules (Adderall XR) Oral

Children 6–12 years of age: Initially, 10 mg once daily; daily dosage may be increased in 5- or 10-mg increments at weekly intervals to a maximum dosage of 30 mg daily.b c Alternatively, initiate with 5 mg once daily when lower initial dosage is appropriate.b c

Adolescents 13–17 years of age: Initially, 10 mg once daily.c Increase to 20 mg once daily after 1 week if symptoms not adequately controlled.c No evidence that dosages >20 mg daily provide any additional benefit.c

When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.b c

Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.a b

Conventional Tablets Oral

Children 6–12 years of age: Initially, 5 mg daily; daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained.a b

Children ≥12 years of age: Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.a b

Maintenance: Usually, 5–60 mg daily, depending on patient age and response, given in divided doses.a b

Adults

Attention Deficit Hyperactivity Disorder Conventional Tablets

Dosage titration usually requires 2–4 weeks.e

Oral

Initially, 5 mg once or twice daily; the daily dosage is increased in 5- to 10-mg increments at weekly intervals until the optimum response is attained.a b e Total daily dosage rarely should exceed 40 mg.a b e

Extended-release Capsules (Adderall XR) Oral

20 mg once daily as initial therapy or when switching from other drugs.c No evidence that dosages >20 mg daily provide any additional benefit.c

When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.b c

Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.a b

Conventional Tablets Oral

Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.a b

Maintenance: Usually, 5–60 mg daily, depending on response, given in divided doses.a b

Prescribing Limits

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Excessive dosage can cause pediatric patients to become overfocused on the medication or to appear dull or overly restricted. Rarely, psychotic reactions, mood disturbances, or hallucinations can occur.

Conventional Tablets Oral

Dosage rarely should exceed a total daily dosage of 40 mg.a b e Individual doses rarely should exceed 10 mg each in children <25 kg.e

Long-term use has not been studied systematically.a If used for long-term therapy, periodically reevaluate the usefulness of the drug.a

Extended-release Capsules (Adderall XR) Oral

Children 6–12 years of age: Dosages >30 mg daily have not been studied systematically.b c

Adolescents 13–17 years of age: Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.c

Long-term use (>3 weeks in children or >4 weeks in adolescents) has not been studied systematically.c If used for long-term therapy, periodically reevaluate the usefulness of the drug.c

Adults

Attention Deficit Hyperactivity Disorder Conventional Tablets Oral

Dosages up to 0.9 mg/kg daily but rarely exceeding 40 mg daily.a b e Such higher doses may be more likely in adults than in school-aged children because of increased dosing frequency to cover a longer work day.e

Tolerance is more likely with relatively high dosages.e

Long-term use has not been studied systematically.a If used for long-term therapy, periodically reevaluate the usefulness of the drug.a

Extended-release Capsules (Adderall XR) Oral

Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.c

Long-term use (>4 weeks) has not been studied systematically.c If used for long-term therapy, periodically reevaluate the usefulness of the drug.c

Special Populations

Hepatic Impairment

No specific hepatic dosage recommendations.a c

Renal Impairment

No specific renal dosage recommendations.a c

Geriatric Patients

No specific geriatric dosage recommendations.a c

Cautions for Adderall

Contraindications

  • Contraindicated in patients with hypersensitivity or idiosyncrasy to the sympathomimetic amines,a c d symptomatic cardiovascular disease,a c d hyperthyroidism,a c d moderate to severe hypertension,a c d glaucoma,a c d e or advanced arteriosclerosis;a c d within 14 days of MAO inhibitor therapy;a c d e and in agitated patients.a c d

  • Although amphetamines generally should not be used in patients with a history of drug abuse,a c d e some experts state that this is not an absolute contraindication, provided the patient can be monitored more carefully than would otherwise be indicated.e

Warnings/Precautions

Warnings

Sudden Death and Serious Cardiovascular Events

Sudden unexplained death, stroke, and MI reported in adults with ADHD receiving usual dosages of stimulants; sudden death also reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of the drugs.a c g

Epidemiologic data suggest a possible association between use of stimulants and sudden unexplained death in healthy children and adolescents.h i j FDA unable to conclude that these data affect evaluation of overall risk and benefit of stimulants used to treat ADHD in children and adolescents.h FDA is conducting an ongoing safety review of amphetamines and other stimulants to evaluate possible link between use of these agents and sudden death in children.h i j Pediatric patients with ADHD and their parents should avoid discontinuing the child’s use of such stimulants before consulting a clinician.h

Thoroughly review medical history (including evaluation for family history of sudden death or ventricular arrhythmia) and perform physical examination in all children, adolescents, and adults being considered for stimulant therapy; if initial findings suggest presence of cardiac disease, perform further cardiac evaluation (e.g., ECG, echocardiogram).a c

In general, avoid use of CNS stimulants in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, CAD, or other serious cardiac conditions.a c g (See Contraindications under Cautions.)

Patients who develop exertional chest pain, unexplained syncope, or other manifestations suggestive of cardiac disease during stimulant therapy should undergo prompt cardiac evaluation.a c

Effects on BP and Heart Rate

Possible modest increases in average BP (i.e., by about 2–4 mm Hg) and heart rate (i.e., by about 3–6 bpm); larger increases may occur.a c Modest increases not expected to have short-term sequelae; however, monitor all patients for larger changes in BP and heart rate.a c

Caution advised in patients with underlying medical conditions that might be affected by increases in BP or heart rate (e.g., hypertension, heart failure, recent MI, ventricular arrhythmia).a c

Exacerbation or Precipitation of Psychotic Symptoms

May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.a c

Psychotic symptoms (e.g., hallucinations, delusional thinking) may occur with usual dosages in children and adolescents without prior history of psychotic illness.a c If psychotic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.a c

Precipitation of Manic Symptoms

May precipitate mixed or manic episodes in ADHD patients with comorbid bipolar disorder; use with caution in these patients.a c Prior to initiating therapy, carefully screen patients with ADHD and comorbid depressive symptoms to identify risk for bipolar disorder; screening should include a detailed psychiatric history (e.g., family history of suicide, bipolar disorder, or depression).a c

Manic symptoms may occur with usual dosages in children and adolescents without prior history of mania.a c If manic symptoms occur, consider causal relationship to stimulants, and discontinue therapy as appropriate.a c

Aggression

Aggressive behavior and hostility (frequently observed in children and adolescents with ADHD) reported in patients receiving drug therapy for ADHD.a c No systematic evidence that stimulants cause these adverse effects; however, monitor patients beginning treatment for ADHD for onset or worsening of aggressive behavior or hostility.a c

Growth Suppression

Long-term (i.e., >14 months) administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.a c Dose-related weight loss reported in adolescents during first 4 weeks of therapy with extended-release capsules.c

Manufacturers recommend monitoring growth during treatment; patients not growing or gaining weight as expected may require temporary discontinuance of treatment.a c However, AAP states that studies of stimulants in children found little or no decrease in expected height, with any decrease in growth early in treatment being compensated for later on.

Seizures

Possible lowering of seizure threshold in patients with history of seizures, in those with prior EEG abnormalities but no history of seizures, and, very rarely, in those without history of seizures and with no prior evidence of EEG abnormalities.a c If seizures occur, discontinue therapy.a c

Visual Effects

Visual disturbances (difficulty with accommodation, blurred vision) reported with stimulants.a c

General Precautions

Least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize possible overdosage.a c

Tics

Amphetamines reported to exacerbate motor and phonic tics and Tourette’s syndrome.a c d However, a history of tics or their development during therapy is not an absolute contraindication to continued use.e Several controlled studies have not found stimulants to worsen or precipitate tics or Tourette’s syndrome.e Nevertheless, evaluate for presence of tics and Tourette’s syndrome in children and their families prior to initiating stimulant therapy.a c d

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.a c f

Risk of prematurity, low birth weight, and withdrawal symptoms (e.g., dysphoria, lassitude, agitation) in infants born to dependent women.a c f

Lactation

Distributed into milk.a c f Discontinue nursing or the drug.a c

Pediatric Use

Not recommended for ADHD in children <3 years of age.a c e

Aggressive behavior, hostility, and psychotic (e.g., hallucinations, delusional thinking) or manic symptoms reported in children and adolescents receiving stimulants for management of ADHD.a c (See Warnings under Cautions.)

Sudden death reported in children and adolescents with structural cardiac abnormalities or other serious cardiac conditions receiving usual dosages of stimulants.a c Epidemiologic data also suggest a possible association between use of stimulants and sudden death in healthy children and adolescents.h i j (See Sudden Death and Serious Cardiovascular Events under Cautions.)

Long-term administration expected to cause at least a temporary suppression of normal weight and/or height patterns in some children and adolescents.a c (See Growth Suppression under Cautions.)

Geriatric Use

Not studied in geriatric patients.a c

Hepatic Impairment

Possible inhibition of drug elimination, resulting in prolonged exposure.a c

Renal Impairment

Possible inhibition of drug elimination, resulting in prolonged exposure.a c

Common Adverse Effects

Palpitations,a c tachycardia,a c elevation of BP,a c overstimulation,a c restlessness,a c dizziness,a c insomnia,a c euphoria,a c dyskinesia,a c dysphoria,a c tremor,a c headache,a c dryness of mouth,a c taste aberration,a c diarrhea,a c constipation,a c abdominal bloating,a c impotence and changes in libido.a c

Isolated reports of cardiomyopathy associated with chronic amphetamine use.a b c

Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect.a c

Actions

  • Amphetamines are sympathomimetic amines with CNS stimulant activity.a c d

  • May block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneural space.a c d

  • Pharmacologic actions of amphetamines are qualitatively similar to those of ephedrine and include CNS and respiratory stimulation and sympathomimetic activity including pressor response, mydriasis, bronchodilation, and contraction of the urinary bladder sphincter.d

  • On a weight basis, dextroamphetamine has a stronger CNS action and a lesser activity on the peripheral nervous system than does the racemic amphetamine.d The CNS stimulating effect of dextroamphetamine is approximately twice that of amphetamine.d

  • Mechanism of action on peripheral structures is thought to be a combination of release of norepinephrine from stores in adrenergic nerve terminals and a direct action on both alpha and beta receptor sites.d

  • Mechanism of action involved in the central effect has not been determined.d The main sites of CNS action appear to be the cerebral cortex and possibly the reticular-activating system; stimulation by an amphetamine causes an increase in motor activity, mental alertness, diminished sense of fatigue, brighter spirits, and mild euphoria.d

  • Theories of dysfunction in ADHD focus on the prefrontal cortex, which controls many executive functions (e.g., planning, impulse control).e Stimulants have putative effects on central dopamine and norepinephrine pathways that are crucial in frontal lobe function.e

  • Produces an anorexigenic effect, leading to loss of weight.d No primary effect on appetite has been demonstrated in humans and it has been postulated that anorexigenic effects are secondary to increased sympathetic activity resulting from release of norepinephrine and dopamine. May also cause a loss of acuity of smell and taste, which may contribute to the anorexigenic effect of the drugs.d

Adderall Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • fast, pounding, or irregular heartbeat or pulse
  • frequent urge to urinate
  • lower back or side pain
Less common
  • Cold or flu-like symptoms
  • cough or hoarseness
  • fever or chills
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • chest pain or discomfort
  • confusion
  • dark-colored urine
  • diarrhea
  • difficulty breathing
  • difficulty with speaking
  • difficulty with swallowing
  • dizziness
  • double vision
  • faintness
  • headache
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • itching, skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of bladder control
  • muscle cramps or spasms
  • muscle pain or stiffness
  • muscle spasm or jerking of all extremities
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seeing, hearing, or feeling things that are not there
  • seizures
  • slow speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden loss of consciousness
  • sweating
  • swelling of the feet or lower legs
  • tightness in the chest
  • uncontrolled repeated movements (tics)
  • uncontrolled vocal outbursts
  • unusual tiredness or weakness
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Anxiety
  • dry mouth
  • lack or loss of strength
  • stomach pain
  • weight loss
Incidence not known
  • Constipation
  • decreased interest in sexual intercourse
  • false or unusual sense of well-being
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some other side effects of Adderall?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Belly pain.
  • Feeling nervous and excitable.
  • Headache.
  • Not hungry.
  • Not able to sleep.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Dizziness.
  • Dry mouth.
  • Bad taste in your mouth.
  • Weight loss.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Medication guide

Adderall® (ADD-ur-all) (CII)
(Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product))

Read the Medication Guide that comes with Adderall® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about you or your child’s treatment with Adderall®.

What is the most important information I should know about Adderall®? 

The following have been reported with use of Adderall® and other stimulant medicines. 

1. Heart-Related Problems:

• sudden death in patients who have heart problems or heart defects

• stroke and heart attack in adults

• increased blood pressure and heart rate

Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems.

Your doctor should check you or your child carefully for heart problems before starting Adderall®.

Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Adderall®.

Call your doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Adderall®.

2. Mental (Psychiatric) Problems:

All Patients

• new or worse behavior and thought problems

• new or worse bipolar illness

• new or worse aggressive behavior or hostility

Children and Teenagers

  • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Adderall®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

3. Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon]:

• Fingers or toes may feel numb, cool, painful • Fingers or toes may change color from pale, to blue, to red

Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Adderall®.

What is Adderall®?

Adderall® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Adderall® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Adderall® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Adderall® is also used in the treatment of a sleep disorder called narcolepsy.

Adderall® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adderall® in a safe place to prevent misuse and abuse. Selling or giving away Adderall® may harm others, and is against the law.  

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take Adderall®?

Adderall® should not be taken if you or your child:

• have heart disease or hardening of the arteries • have moderate to severe high blood pressure • have hyperthyroidism • have an eye problem called glaucoma • are very anxious, tense, or agitated • have a history of drug abuse • are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI. • are sensitive to, allergic to, or had a reaction to other stimulant medicines

Adderall® is not recommended for use in children less than 3 years old.

Adderall® may not be right for you or your child. Before starting Adderall® tell your or your child’s doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure • mental problems including psychosis, mania, bipolar illness, or depression • tics or Tourette’s syndrome • liver or kidney problems • circulation problems in fingers and toes • thyroid problems • seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child are pregnant, planning to become pregnant, or breastfeeding.

Can Adderall® be taken with other medicines?

Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Adderall® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Adderall®.

Your doctor will decide whether Adderall® can be taken with other medicines.

Especially tell your doctor if you or your child take:

• anti-depression medicines including MAOIs • blood pressure medicines • seizure medicines • blood thinner medicines • cold or allergy medicines that contain decongestants • stomach acid medicines

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.

Do not start any new medicine while taking Adderall® without talking to your doctor first.

How should Adderall® be taken?

• Take Adderall® exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. • Adderall® tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart. • Adderall® can be taken with or without food. • From time to time, your doctor may stop Adderall® treatment for a while to check ADHD symptoms. • Your doctor may do regular checks of the blood, heart, and blood pressure while taking Adderall®. Children should have their height and weight checked often while taking Adderall®. Adderall® treatment may be stopped if a problem is found during these check-ups. • If you or your child take too much Adderall® or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of Adderall®?

See “What is the most important information I should know about Adderall®?” for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children • seizures, mainly in patients with a history of seizures • eyesight changes or blurred vision • serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when medicines such as Adderall® are taken with certain other medicines. Symptoms of serotonin syndrome may include: • agitation, hallucinations, coma or other changes in mental status • problems controlling your movements or muscle twitching • fast heartbeat • high or low blood pressure • sweating or fever • nausea or vomiting • diarrhea • muscle stiffness or tightness

Common side effects include:

• stomach ache • decreased appetite • nervousness

Adderall® may affect your or your child’s ability to drive or do other dangerous activities.

Talk to your doctor if you or your child have side effects that are bothersome or do not go away.

This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Adderall®? 

• Store Adderall® in a safe place at room temperature, 20° to 25°C (68° to 77°F). • Keep Adderall® and all medicines out of the reach of children.

General information about Adderall®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Adderall® for a condition for which it was not prescribed. Do not give Adderall® to other people, even if they have the same condition. It may harm them and it is against the law. This Medication Guide summarizes the most important information about Adderall®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Adderall® that was written for healthcare professionals. For more information about Adderall®, please contact Teva Pharmaceuticals at 1-888-838-2872.

What are the ingredients in Adderall®?

Active Ingredient: dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate.

Inactive Ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. The 5 mg is a white to off-white tablet, which contains no color additives. The 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake as a color additive. The 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake as a color additive.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Teva Select Brands, North Wales, PA 19454

Division of Teva Pharmaceuticals USA, Inc.

Rev. G 9/2016

Important information

Adderall may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use this medicine if you have used a MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Adderall may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems - chest pain, feeling light-headed or short of breath; signs of psychosis - paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems - unexplained wounds on your fingers or toes.

You may not be able to use Adderall if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.

For Healthcare Professionals

Applies to amphetamine / dextroamphetamine: oral capsule extended release, oral tablet

Metabolic

Very common (10% or more): Appetite loss (up to 36%), weight loss (up to 10%)
Frequency not reported: Anorexia[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 35%), abdominal pain (up to 14%)
Common (1% to 10%): Nausea, vomiting, diarrhea, dyspepsia
Frequency not reported: Unpleasant taste, constipation, other GI disturbances[Ref]

Cardiovascular

Very common (10% or more): Transient blood pressure elevations (up to 35%)
Common (1% to 10%): Tachycardia, palpitation
Frequency not reported: Cardiomyopathy, myocardial infarction, Raynaud's phenomenon[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 27%), nervousness (up to 13%)
Common (1% to 10%): Emotional lability, agitation, anxiety
Frequency not reported: Psychotic episodes, irritability, euphoria, dysphoria, restlessness, depression, aggression, anger, logorrhea, dermatillomania[Ref]

Nervous system

Very common (10% or more): Headache (up to 26%)
Common (1% to 10%): Somnolence, dizziness, twitching, speech disorder (e.g., stuttering, excessive speech)
Frequency not reported: Overstimulation, paresthesia/formication, dyskinesia, tremor, exacerbation of motor/phonic tics and Tourette's syndrome[Ref]

Dermatologic

Common (1% to 10%): Photosensitivity reaction, sweating
Frequency not reported: Urticaria, rash, alopecia, serious skin rashes (e.g., Stevens-Johnson Syndrome, toxic epidermal necrolysis)[Ref]

Endocrine

Common (1% to 10%): Decreased libido, dysmenorrhea, impotence
Frequency not reported: Frequent or prolonged erections[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Other

Common (1% to 10%): Fever, infection, accidental injury, asthenia/fatigue, tooth disorder (e.g., teeth clenching, tooth infection)
Frequency not reported: Sudden death, bruxism[Ref]

Respiratory

Common (1% to 10%): Dyspnea[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions (e.g., angioedema, anaphylaxis)[Ref]

Ocular

Frequency not reported: Blurred vision, mydriasis[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis[Ref]

Some side effects of Adderall may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

What is the most important information I should know about amphetamine and dextroamphetamine?

Amphetamine and dextroamphetamine may be habit-forming, and this medicine is a drug of abuse. Tell your doctor if you have had problems with drug or alcohol abuse.

Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.

Do not use this medivine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Amphetamine and dextroamphetamine may cause new or worsening psychosis (unusual thoughts or behavior), especially if you have a history of depression, mental illness, or bipolar disorder.

You may have blood circulation problems that can cause numbness, pain, or discoloration in your fingers or toes.

Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real; signs of circulation problems--unexplained wounds on your fingers or toes.

You may not be able to use this medicine if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.

What should I discuss with my healthcare provider before taking amphetamine and dextroamphetamine?

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You may not be able to use amphetamine and dextroamphetamine if you are allergic to any stimulant medicine. You may not be able to use this medicine if you have:

  • high blood pressure, heart disease, coronary artery disease (hardened arteries);

  • overactive thyroid;

  • glaucoma;

  • severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

  • a history of drug or alcohol addiction.

Some medicines can interact with amphetamine and dextroamphetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

  • heart problems or a congenital heart defect;

  • high blood pressure; or

  • a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

  • depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

  • motor tics (muscle twitches) or Tourette's syndrome;

  • seizures or epilepsy;

  • an abnormal brain wave test (EEG); or

  • blood circulation problems in the hands or feet.

Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Amphetamine and dextroamphetamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using this medicine.

Amphetamine and dextroamphetamine is not approved for use by anyone younger than 6 years old.

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