The following events occurred in 1% to less than 3% of psoriasis patients treated with cyclosporine:

Body as a Whole

fever, flushes, hot flushes

Cardiovascular

chest pain

Central and Peripheral Nervous System

appetite increased, insomnia, dizziness, nervousness, vertigo

Gastrointestinal

abdominal distention, constipation, gingival bleeding; Liver and Biliary System: hyperbilirubinemia

Neoplasms

skin malignancies [squamous cell (0.9%) and basal cell (0.4%) carcinomas]

Reticuloendothelial

platelet, bleeding, and clotting disorders, red blood cell disorder

Respiratory

infection, viral and other infection

Skin and Appendages

acne, folliculitis, keratosis, pruritus, rash, dry skin

Urinary System

micturition frequency

Vision

abnormal vision.

Mild hypomagnesemia and hyperkalemia may occur but are asymptomatic. Increases in uric acid may occur and attacks of gout have been rarely reported. A minor and dose related hyperbilirubinemia has been observed in the absence of hepatocellular damage. Cyclosporine therapy may be associated with a modest increase of serum triglycerides or cholesterol. Elevations of triglycerides (> 750 mg/dL) occur in about 15% of psoriasis patients; elevations of cholesterol (> 300 mg/dL) are observed in less than 3% of psoriasis patients. Generally these laboratory abnormalities are reversible upon dose reduction or discontinuation of cyclosporine.

OVERDOSAGE

There is a minimal experience with cyclosporine overdosage. Forced emesis can be of value up to 2 hours after administration of Gengraf (cyclosporine oral solution, USP [MODIFIED]). Transient hepatotoxicity and nephrotoxicity may occur which sh