Aspirin and oxycodone

Follow all directions on your prescription label. Oxycodone can slow or stop your breathing. Never use aspirin and oxycodone in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away aspirin and oxycodone is against the law.

Aspirin and oxycodone may be taken with food if it upsets your stomach.

If you need surgery, tell the surgeon ahead of time that you are using aspirin and oxycodone. You may need to stop using the medicine for a short time.

Do not stop using aspirin and oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep unused aspirin and oxycodone that is no longer needed. Ask your pharmacist where to locate a community drug take-back disposal program. If there is no take-back program, flush any unused medicine down the toilet.

Since aspirin and oxycodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Applies to aspirin / oxycodone: oral tablet

Along with its needed effects, aspirin / oxycodone 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 while taking aspirin / oxycodone:

• Abdominal pain, cramping, or tenderness
• agitation
• bleeding gums
• bloating
• blood in the urine or stools
• bloody, black, or tarry stools
• blue lips, fingernails, or skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in consciousness or confusion
• chest pain or discomfort
• chills
• clay-colored stools
• constipation
• convulsions
• coughing or vomiting blood
• dark-colored urine
• decrease in urine volume or frequency
• decreased appetite
• depression
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• feeling of hostility or irritability
• feeling of warmth
• feeling that something terrible will happen
• fever
• headache, sudden, severe
• heartburn
• hives, itching, or skin rash
• increased menstrual flow or vaginal bleeding
• increased sweating
• indigestion
• irregular, fast, slow, or shallow breathing
• large, flat, blue or purplish patches in the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of consciousness
• muscle cramping, weakness, or tremors
• muscle pain or stiffness
• nausea or vomiting
• nosebleeds
• numbness or tingling in the hands, feet, or lips
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red or purple spots on the skin
• prolonged bleeding from cuts
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red or black, tarry stools or dark urine
• restlessness
• shivering
• sleepiness
• sunken eyes
• sweating
• swelling of face, ankles, hands, feet, or lower legs
• thirst
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting of material that looks like coffee grounds, severe and continuing
• weak or feeble pulse
• weakness or heaviness of the legs
• weight gain
• wrinkled skin
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking aspirin / oxycodone:

• Continuing ringing or buzzing or other unexplained noise in the ears
• decreased awareness or responsiveness
• diarrhea
• drowsiness
• enlarged pupils
• extremely high fever or body temperature
• fast, weak heartbeat
• hearing loss
• increase in heart rate
• restlessness
• severe sleepiness

Some side effects of aspirin / oxycodone 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:

• Relaxed and calm feeling
• sleepiness

• Belching
• bloated, full feeling
• blurred or loss of vision
• change in color perception
• cold sweats
• constricted, pinpoint, or small pupils (black part of the eye)
• cool, pale skin
• double vision
• excess air or gas in the stomach
• false or unusual sense of well-being
• flushed, dry skin
• fruit-like breath odor
• halos around lights
• increased hunger or thirst
• increased urination
• lack or loss of strength
• night blindness
• nightmares
• overbright appearance of lights
• red eyes
• redness of the skin
• seeing, hearing, or feeling things that are not there
• shakiness
• sleepiness or unusual drowsiness
• slurred speech
• trouble sleeping
• tunnel vision
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• weight loss

Applies to aspirin / oxycodone: oral tablet

General

The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]

Gastrointestinal

Oxycodone-Aspirin:
Frequency not reported: Nausea, vomiting, constipation
Postmarketing reports: Hemorrhagic gastric/duodenal ulcer, gastric/peptic ulcer, dyspepsia, abdominal pain, diarrhea, eructation, dry mouth, gastrointestinal bleeding, intestinal perforation, pancreatitis, intestinal obstruction, ileus, thirst, aspiration

Aspirin:
Frequency not reported: Anorexia[Ref]

Nervous system

Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation
Postmarketing reports: Stupor, paresthesia, cerebral edema, coma, subdural or intracranial hemorrhage, seizures

Opioids:
Postmarketing reports: Serotonin syndrome[Ref]

Renal

Postmarketing reports: Renal insufficiency and failure[Ref]

Hematologic

Oxycodone-aspirin:
Postmarketing reports: Unspecified hemorrhage, purpura, reticulocytosis, prolongation of prothrombin time, disseminated intravascular coagulation, ecchymosis, thrombocytopenia

Aspirin:
Frequency not reported: Leukopenia, thrombocytopenia, purpura, decreased iron concentration, shortened erythrocyte survival time[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]

Cardiovascular

Frequency not reported: Hypotension
Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations[Ref]

Metabolic

Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, dehydration, hyperkalemia[Ref]

Other

Postmarketing reports: Malaise, asthenia, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]

Hepatic

Oxycodone-aspirin:
Postmarketing reports: Transient elevations of hepatic enzymes, hepatitis, Reye syndrome

Aspirin:
Frequency not reported: Reversible hepatotoxicity[Ref]

Psychiatric

Frequency not reported: Euphoria, dysphoria
Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination[Ref]

Dermatologic

Frequency not reported: Pruritus
Postmarketing reports: Urticaria, rash, flushing, increased sweating[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis

Ocular

Postmarketing reports: Miosis, visual disturbances, red eye

Genitourinary

Frequency not reported: Urinary retention, interstitial nephritis, proteinuria

Respiratory

Frequency not reported: Apnea, respiratory arrest, respiratory depression
Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema

Endocrine

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency

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

Not recommended Excreted into human milk: Yes Comments: -If used, monitor breastfed infants for excess sedation and respiratory depression. -Withdrawal symptoms may occur in breastfed infants when maternal administration of an opioid is stopped or when breast-feeding is stopped.

Maternal use of narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of oxycodone. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics. Adverse effects on platelet function are possible when nursing infants are exposed to aspirin; the risk of Reye Syndrome caused by salicylate in breast milk is unknown.