Apo-Carbamazepine Adverse Reactions





Full Prescribing Info
Adverse Reactions
The most frequently reported are drowsiness, unsteadiness on the feet, vertigo/dizziness, gastrointestinal disturbance, and nausea. These reactions usually occur only during the initial phase of therapy. They rarely necessitate discontinuing carbamazepine therapy. Minimize reactions by initiating treatment at a low dosage.
Hematologic, hepatic, cardiovascular and dermatologic reactions are more serious and require discontinuance of therapy.
Hematological Reactions: Transitory leukopenia, eosinophilia, leukocytosis, thrombocytopenic purpura, agranulocytosis, macrocytic anemia and aplastic anemia. In a few instances, deaths have occurred.
Hepatic Disturbances: Abnormalities in liver function tests and cholestatic or hepatocellular jaundice during long term administration of carbamazepine.
Dermatological Reactions: Skin sensitivity reactions and rashes, erythematous rashes, pruritic eruptions, urticaria, photosensitivity, pigmentary changes, neurodermatitis and, in rare cases, Steven-Johnson syndrome, exfoliative dermatitis, alopecia, diaphoresis, erythema multiforms, erythema nodosum, and aggravation of disseminated lupus erythematosus.
Neurological Reactions: Reported reactions occurring during treatment with carbamazepine include vertigo, somnolence, disturbances of coordination, confusion, headache, fatigue, blurred vision, transient diplopia and oculomotor disturbances, speech disturbances, abnormal involuntary movements and increase in motor seizures. In addition, peripheral neuritis and paresthesia, depression with agitation, talkativeness, nystagmus, and tinnitus have been reported but only very rarely. There have been some reports of paralysis and other symptoms of cerebral arterial insufficiency, but no conclusive relationship to the administration of carbamazepine could be established.
Cardiovascular System: Recurrence of thrombophlebitis in patients with a prior history of thrombophlebitis, congestive heart failure, aggravation of hypertension. Stock's Adams in patients with AV block, hypotension, syncope and collapse, edema, aggravation of coronary artery disease. Some of these complications have resulted in fatalities. Other cardiovascular complication (including myocardial infarction and arrhythmia) have been associated with other tricyclic compounds. Whether all these complications are drug-related is not known at this time.
Genitourinary Reactions: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, and impotence, elevation of BUN, albuminuria, and glycosuria have also been observed.
Digestive Tract: Nausea, vomiting, gastric or abdominal discomfort, diarrhea, anorexia, dryness of mouth and throat, glossitis and stomatitis.
Eyes: No conclusive evidence that carbamazepine produced pathological changes in the cornea, lens or retina. However, many phenothiazines and related drugs have been shown to cause eye changes. Periodic eye examinations, including slit lamp fundoscopy and tonometry are recommended.
Other Reported Reactions: Fever and chills, lymphadenopathy, aching joints and muscles, leg cramps and conjunctivitis.
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