Cophene B Side Effects
Generic Name: brompheniramine
Note: This document contains side effect information about brompheniramine. Some of the dosage forms listed on this page may not apply to the brand name Cophene B.
For the Consumer
Applies to brompheniramine: oral liquid, oral tablet chewable, oral tablet extended release 12 hour
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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Chest pain or pressure or a fast heartbeat.
- A heartbeat that does not feel normal.
- Shortness of breath.
- Change in balance.
- Change in eyesight.
- Mood changes.
- Hallucinations (seeing or hearing things that are not there).
- Very bad sore throat.
- Fever or chills.
- Trouble passing urine.
- Any unexplained bruising or bleeding.
- Very bad dizziness or passing out.
- Feeling very tired or weak.
- Feeling confused.
What are some other side effects of this drug?
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:
- Feeling sleepy.
- Feeling nervous and excitable.
- Dry mouth.
- Dry nose.
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.
For Healthcare Professionals
Applies to brompheniramine: compounding powder, injectable solution, oral capsule, oral capsule extended release, oral liquid, oral suspension extended release, oral tablet, oral tablet chewable extended release, oral tablet extended release
Nervous system side effects have included central nervous system (CNS) depression, resulting in drowsiness and sedation in nearly 50% of patients treated. This effect has often been transient and ceased with continued use. Motor skills have be impaired and patients should be advised to avoid tasks which require attention. Patients should also avoid concomitant use with alcohol and other sedative-hypnotic drugs. Dyskinesias have rarely been reported following chronic use of brompheniramine (the active ingredient contained in Cophene B) [Ref]
A few cases of dyskinesias and tremors, often of the face, have been reported in patients whose chronic use of brompheniramine extended over a period of up to 10 years. Some of these cases were only partially relieved by discontinuation of the drug. Haloperidol was successful in relieving symptoms in these patients. Spasmodic torticollis has been reported in a child given brompheniramine over an eight month period.[Ref]
Ocular side effects have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]
1. Thach BT, Chase TN, Bosma JF "Oral facial dyskinesia associated with prolonged use of antihistaminic decongestants." N Engl J Med 293 (1975): 486-7
2. Blamoutier J "Comparative trial of two antihistamines, mequitazine and brompheniramine." Curr Med Res Opin 5 (1978): 366-70
3. Schuller DE, Turkewitz D "Adverse effects of antihistamines." Postgrad Med 79 (1986): 75-86
4. Lewith GT, Davidson F "Dystonic reactions to Dimotapp elixir." J R Coll Gen Pract 31 (1981): 241
5. Simons FE, Frith EM, Simons KJ "The pharmacokinetics and antihistaminic effects of brompheniramine." J Allergy Clin Immunol 70 (1982): 458-64
Some side effects may not be reported. You may report them to the FDA.