Carbatrol (Carbamazepine) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

General: 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 patient with epilepsy may lead to seizures or even status epilepticus with its life-threatening hazards.

The most severe adverse reactions previously observed with carbamazepine were reported in the hemopoietic system (see BOX WARNING), the skin, 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 lowest dosage recommended.

The following additional adverse reactions were previously reported with carbamazepine:

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.

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/day 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: 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 SUSPECTED CARBATROL SIDE EFFECTS / ADVERSE REACTIONS

Possible Carbatrol side effects / adverse reactions in 32 year old female

Reported by a physician from United States on 2011-10-20

Patient: 32 year old female weighing 48.0 kg (105.6 pounds)

Reactions: Grand MAL Convulsion, Overdose, Hypotension, Nervous System Disorder, Suicide Attempt, Hypoxia, Coma, Cardiovascular Disorder

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Carbatrol
    Dosage: unk, unknown
    Administration route: Oral
    Indication: Convulsion

Acetaminophen
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Ethanol
    Dosage: unk, unknown
    Indication: Product Used FOR Unknown Indication

Carbatrol
    Dosage: unk, unknown

Possible Carbatrol side effects / adverse reactions in 50 year old male

Reported by a consumer/non-health professional from United States on 2011-11-21

Patient: 50 year old male

Reactions: Brain Neoplasm

Adverse event resulted in: death

Suspect drug(s):
Carbatrol

Possible Carbatrol side effects / adverse reactions in 4 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-25

Patient: 4 year old male weighing 19.0 kg (41.8 pounds)

Reactions: Functional Gastrointestinal Disorder, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Carbatrol
    Dosage: 100 mg, 2x/day:bid, oral ; 200 mg, 2x/day:bid, oral
    Administration route: Oral
    Indication: Convulsion
    Start date: 2011-01-01
    End date: 2011-01-01

Carbatrol
    Dosage: 100 mg, 2x/day:bid, oral ; 200 mg, 2x/day:bid, oral
    Administration route: Oral
    Indication: Convulsion
    Start date: 2010-01-01
    End date: 2011-01-01