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.
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REPORTS OF SUSPECTED CARBATROL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Carbatrol. The information is not vetted and should not be considered as verified clinical evidence.
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
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