Lodrane 12D Side Effects
Generic Name: brompheniramine / pseudoephedrine
Note: This page contains information about the side effects of brompheniramine / pseudoephedrine. Some of the dosage forms included on this document may not apply to the brand name Lodrane 12D.
For the Consumer
Applies to brompheniramine / pseudoephedrine: capsules, controlled-release and sustained-release capsules, drops, elixir, liquid, suspension, sustained-release tablets, syrup, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking brompheniramine / pseudoephedrine:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.
For Healthcare Professionals
Applies to brompheniramine / pseudoephedrine: oral capsule, oral capsule extended release, oral elixir, oral liquid, oral suspension extended release, oral syrup, oral tablet, oral tablet chewable, oral tablet extended release
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]
Nervous system side effects of brompheniramine 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. Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.[Ref]
Gastrointestinal side effects of brompheniramine have include nausea, dry mouth and constipation. Gastrointestinal side effects of pseudoephedrine have included anorexia and gastric irritation in approximately 5% of patients. Dry mouth, nose, or throat have occurred in up to 15% of patients receiving pseudoephedrine.[Ref]
Cardiovascular effects of brompheniramine have included hypotension, tachycardia, and palpitations. Cardiovascular side effects of pseudoephedrine have included tachycardia. Some patients taking pseudoephedrine have developed hypertension and/or arrhythmias.[Ref]
Pseudoephedrine causes vasoconstriction which generally does not produce hypertension, but may be problematic for patients with preexisting hypertension. Arrhythmias may be produced in predisposed patients. Rarely, pseudoephedrine has been reported to cause coronary artery spasm and chest pain.
One report evaluated the effect with 60 mg of pseudoephedrine on individuals in a hyperbaric chamber at 1 atmosphere (simulated scuba dive to 66 feet of sea water). Pseudoephedrine and depth (stimulated) were found to have significant but opposite effects on heart rate, although these effects were unlikely to be clinically significant during diving.[Ref]
Ocular side effects of brompheniramine have included blurred vision, diplopia, and dry eyes due to anticholinergic effects.[Ref]
Hematologic side effects of brompheniramine have included rare cases of hemolytic anemia, thrombocytopenia, and agranulocytosis.[Ref]
Hypersensitivity side effects in patients receiving pseudoephedrine have included fixed drug eruptions.[Ref]
Genitourinary side effects of brompheniramine have included dysuria, urinary hesitancy, decrease in urine flow, and, in rare cases, acute urinary retention.[Ref]
1. Schuller DE, Turkewitz D "Adverse effects of antihistamines." Postgrad Med 79 (1986): 75-86
2. Lewith GT, Davidson F "Dystonic reactions to Dimotapp elixir." J R Coll Gen Pract 31 (1981): 241
3. Simons FE, Frith EM, Simons KJ "The pharmacokinetics and antihistaminic effects of brompheniramine." J Allergy Clin Immunol 70 (1982): 458-64
4. Blamoutier J "Comparative trial of two antihistamines, mequitazine and brompheniramine." Curr Med Res Opin 5 (1978): 366-70
5. Lyon CC, Turney JH "Pseudoephedrine toxicity in renal failure." Br J Clin Pract 50 (1996): 396-7
6. Thach BT, Chase TN, Bosma JF "Oral facial dyskinesia associated with prolonged use of antihistaminic decongestants." N Engl J Med 293 (1975): 486-7
7. Dowd J, Bailey D, Moussa K, Nair S, Doyle R, CulpepperMorgan JA "Ischemic colitis associated with pseudoephedrine: Four cases." Am J Gastroenterol 94 (1999): 2430-4
8. Gill ND, Shield A, Blazevich AJ, Zhou S, Weatherby RP "Muscular and cardiorespiratory effects of pseudoephedrine in human athletes." Br J Clin Pharmacol 50 (2000): 205-13
9. Taylor DM, O'Toole KS, Auble TE, Ryan CM, Sherman DR "The psychometric and cardiac effects of pseudoephedrine in the hyperbaric environment." Pharmacotherapy 20 (2000): 1045-50
10. Mores N, Campia U, Navarra P, Cardillo C, Preziosi P "No cardiovascular effects of single-dose pseudoephedrine in patients with essential hypertension treated with beta-blockers." Eur J Clin Pharmacol 55 (1999): 251-4
11. Vidal C, Prieto A, PerezCarral C, Armisen M "Nonpigmenting fixed drug eruption due to pseudoephedrine." Ann Allergy Asthma Immunol 80 (1998): 309-10
Not all side effects for Lodrane 12D may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
More about Lodrane 12D (brompheniramine / pseudoephedrine)
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