Carbamazepine (Carbamazepine) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.

The most severe adverse reactions have been observed in the hemopoietic system (see boxed WARNING), the skin, liver, and the cardiovascular system.

The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the low dosage recommended.

The following additional adverse reactions have been reported:

Hemopoietic System: Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria.

Skin: Pruritic and erythematous rashes, urticaria, toxic epidermal necrolysis (Lyell’s syndrome) (see WARNINGS), Stevens-Johnson syndrome (see WARNINGS), photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, and diaphoresis. In certain cases, discontinuation of therapy may be necessary. Isolated cases of hirsutism have been reported, but a causal relationship is not clear.

Cardiovascular System: Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism, and adenopathy or lymphadenopathy.

Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

Liver: Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure.

Pancreatic: Pancreatitis.

Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

Genitourinary System: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported.

Testicular atrophy occurred in rats receiving carbamazepine orally from 4-52 weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.

Nervous System: Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, and hyperacusis.

There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established. Isolated cases of neuroleptic malignant syndrome have been reported with concomitant use of psychotropic drugs.

Digestive System: Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis.

Eyes: Scattered punctate cortical lens opacities, as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes.

Musculoskeletal System: Aching joints and muscles, and leg cramps.

Metabolism: Fever and chills. Inappropriate antidiuretic hormone (ADH) secretion syndrome has been reported. Cases of frank water intoxication, with decreased serum sodium (hyponatremia) and confusion, have been reported in association with carbamazepine use (see PRECAUTIONS: Laboratory Tests). Decreased levels of plasma calcium have been reported.

Other: Multi-organ hypersensitivity reactions occurring days to weeks or months after initiating treatment have been reported in rare cases. Signs or symptoms may include, but are not limited to fever, skin rashes, vasculitis, lymphadenopathy, disorders mimicking lymphoma, arthralgia, leukopenia, eosinophilia, hepato-splenomegaly and abnormal liver function tests. These signs and symptoms may occur in various combinations and not necessarily concurrently. Signs and symptoms may initially be mild. Various organs, including but not limited to, liver, skin, immune system, lungs, kidneys, pancreas, myocardium, and colon may be affected (see PRECAUTIONS, General and PRECAUTIONS, Information for Patients).

Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CARBAMAZEPINE

Possible Carbamazepine side effects / adverse reactions in 54 year old male

Reported by a individual with unspecified qualification from Japan on 2007-01-04

Patient: 54 year old male

Reactions: Locked-in Syndrome, Hyponatraemia, Neuroleptic Malignant Syndrome, Blood Glucose Increased, Ileus Paralytic, Loss of Consciousness, Pallanaesthesia

Adverse event resulted in: hospitalization

Suspect drug(s):
Biperiden Hydrochloride TAB
    Administration route: Oral
    Indication: Alcoholic Psychosis
    End date: 2004-06-01

Biperiden Hydrochloride TAB
    Indication: Insomnia

Biperiden Hydrochloride TAB
    Indication: Irritability

Biperiden Hydrochloride TAB
    Indication: Mental Disorder

Estazolam
    Administration route: Oral
    Indication: Alcoholic Psychosis
    End date: 2004-06-01

Estazolam
    Indication: Insomnia

Estazolam
    Indication: Irritability

Estazolam
    Indication: Mental Disorder

Carbamazepine
    Administration route: Oral
    Indication: Alcoholic Psychosis
    End date: 2004-06-01

Carbamazepine
    Indication: Insomnia

Carbamazepine
    Indication: Irritability

Carbamazepine
    Indication: Mental Disorder

Chlorpromazine
    Administration route: Oral
    Indication: Alcoholic Psychosis
    End date: 2004-06-01

Chlorpromazine
    Indication: Insomnia

Chlorpromazine
    Indication: Irritability

Chlorpromazine
    Indication: Mental Disorder

Haloperidol
    Administration route: Oral
    Indication: Alcoholic Psychosis
    End date: 2004-06-01

Haloperidol
    Indication: Insomnia

Haloperidol
    Indication: Irritability

Haloperidol
    Indication: Mental Disorder

Other drugs received by patient: Anti-Diabetics; Insulin Human; Laxatives

Possible Carbamazepine side effects / adverse reactions in 49 year old female

Reported by a individual with unspecified qualification from United States on 2007-01-10

Patient: 49 year old female

Reactions: Cryptogenic Organising Pneumonia, Hypogammaglobulinaemia

Suspect drug(s):
Carbamazepine

Possible Carbamazepine side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2007-01-11

Patient: 72 year old female

Reactions: Hyponatraemia, Fall

Adverse event resulted in: hospitalization

Suspect drug(s):
Hyzaar
    Administration route: Oral
    Indication: Hypertension
    End date: 2006-11-18

Althiazide and Spironolactone
    Administration route: Oral
    Indication: Hypertension
    End date: 2006-11-18

Carbamazepine
    Administration route: Oral
    Indication: Epilepsy
    End date: 2006-11-18

Risperidone
    Administration route: Oral
    Indication: Psychotic Disorder
    End date: 2006-11-18

Escitalopram Oxalate
    Administration route: Oral
    Indication: Dysthymic Disorder
    End date: 2006-11-18

Other drugs received by patient: Celiprolol Hydrochloride