Banophen (Diphenhydramine Capsules and Tablets)

Name: Banophen (Diphenhydramine Capsules and Tablets)

What do I need to tell my doctor BEFORE I take Banophen?

  • If you have an allergy to diphenhydramine or any other part of Banophen (diphenhydramine capsules and tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Banophen?

  • Tell all of your health care providers that you take Banophen. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
  • Do not take this medicine for longer than you were told by your doctor.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how Banophen affects you.
  • Do not use with other products that have diphenhydramine.
  • Avoid drinking alcohol while taking this medicine.
  • Talk with your doctor before you use other drugs and natural products that slow your actions.
  • If you are 60 or older, use Banophen with care. You could have more side effects.
  • Use with care in children. Talk with the doctor.
  • Different brands of this medicine may be for use in different ages of children. Talk with the doctor before giving Banophen to a child.
  • Do not use to make a child sleepy. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Very bad dizziness or passing out.
  • Change in balance.

In Summary

More frequent side effects include: sedation and thickening of bronchial secretions. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to diphenhydramine: oral capsules and tablets, parenteral injection

Side effects include:

Sedation, sleepiness, dizziness, disturbed coordination, epigastric distress, thickening of bronchial secretions.

For Healthcare Professionals

Applies to diphenhydramine: compounding powder, injectable solution, oral capsule, oral disintegrating strip, oral liquid, oral tablet, oral tablet chewable, oral tablet disintegrating

General

The most commonly reported side effects included somnolence, dizziness, and incoordination.[Ref]

Nervous system

Common (1% to 10%): Sedation/somnolence/sleepiness, drowsiness, unsteadiness, dizziness, headache, attention disturbance
Rare (0.01% to 0.1%): Extrapyramidal effects, tremor, convulsions
Frequency not reported: Paresthesia, dyskinesia/muscle dyskinesia, vertigo, neuritis, incoordination, psychomotor impairment, activation of epileptogenic foci[Ref]

Drowsiness usually diminishes after a few days.[Ref]

Gastrointestinal

Common (1% to 10%): Dry mouth
Frequency not reported: Gastrointestinal disturbance, nausea, vomiting, constipation, diarrhea, dyspepsia, epigastric distress[Ref]

Other

Common (1% to 10%): Fatigue
Frequency not reported: Lassitude, tinnitus, acute labyrinthitis, asthenia, chills, impaired performance (including impaired driving, work, and/or information processing)[Ref]

Psychiatric

Rare (0.01% to 0.1%): Confusion, depression, sleep disturbances
Frequency not reported: Paradoxical excitation/excitation, agitation, increased energy, restlessness, nervousness, euphoria, anxiety, hallucinations, insomnia, irritability[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Palpitations, hypotension, arrhythmia
Frequency not reported: Tachycardia, chest tightness, extrasystoles[Ref]

Hematologic

Rare (0.01% to 0.1%): Blood disorders
Frequency not reported: Hemolytic anemia, thrombocytopenia, agranulocytosis[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Frequency not reported: Angioedema, anaphylactic shock[Ref]

Hepatic

Rare (0.01% to 0.1%): Liver dysfunction[Ref]

Dermatologic

Frequency not reported: Rash, urticaria, skin rashes, erythema, photosensitivity, pruritus, drug rash, excessive perspiration[Ref]

Respiratory

Frequency not reported: Dyspnea, thickening of bronchial secretions, throat tightening, wheezing, nasal stuffiness, dry nose or throat[Ref]

Genitourinary

Frequency not reported: Urinary hesitancy/difficulty/retention, dysuria, early menses[Ref]

Ocular

Frequency not reported: Blurred vision, dry eyes, diplopia[Ref]

Metabolic

Frequency not reported: Increased appetite, anorexia[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching/weakness[Ref]

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

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