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CAS No 298-46-4
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: Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS)
(see BOXED WARNING), pruritic and erythematous rashes, urticaria,
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.
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 Tegretol orally from 4-52
weeks at dosage levels of 50-400 mg/kg/day. Additionally, rats receiving
Tegretol 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
Musculoskeletal System: Aching joints and muscles, and leg cramps.