Giga Adverse Reactions

Pituitary adrenal axis abnormalities including glucose intolerance, new onset diabetes, exacerbation of pre-existing diabetes with decreased glucose tolerance and Cushing's syndrome have been reported with the use of megestrol acetate. Clinically apparent adrenal insufficiency has been rarely reported in patients shortly after discontinuing megestrol acetate. The possibility of adrenal suppression should be considered in all patients taking or withdrawing from chronic megestrol acetate therapy. Replacement stress doses of glucocorticoids may be indicated. Patients should be observed when Giga is abruptly withdrawn. In clinical trials in patients with AIDS there was no significant difference between active and placebo treatment in patients reporting at least one adverse event. Events reported in ≥ 5% of these study patients included diarrhoea, impotence, rash. Other reported adverse events included flatulence, asthenia, and pain. Similarly in patients with advanced non-endocrine sensitive cancer who received megestrol acetate for anorexia and weight loss, dyspnoea, nausea, oedema, pain, lethargy and diarrhea were commonly observed. Constipation and urinary frequency have also been reported in patients who received high doses of megestrol acetate in clinical trials. A rarely encountered side effect of prolonged administration of megestrol acetate is urticaria, presumably an idiosyncratic reaction to the drug.
The drug is devoid of the myelosuppressive activity characteristic of many cytotoxic drugs and it causes no significant changes in haematology, blood chemistry or urinalysis. The list is presented by system organ class, MedDRA preferred term, and frequency using the following frequency categories: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000), very rare (<1/10000), and not known (cannot be estimated from the available data). (See table.)

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