Provera Adverse Reactions

10 mg: The following medical events, listed in order of seriousness rather than frequency of occurrence, have been occasionally to rarely associated with the use of progestogens: Anaphylaxis and anaphylactoid-like reactions.
Thromboembolic disorders including thrombophlebitis and pulmonary embolism.
Central nervous system-nervousness, insomnia, somnolence, fatigue, depression, dizziness, and headache.
Skin and mucous membranes-urticaria, pruritus, rash, acne, hirsutism and alopecia.
Gastrointestinal-nausea.
Breast tenderness and galactorrhea.
Miscellaneous-pyrexia, changes in weight and moon faces.
Breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, edema, change in weight (increase or decrease), change in cervical erosion and cervical secretions, cholestatic jaundice.
Gynecology: The table as follows provides a listing of adverse drug reactions with frequency based on all-causality data from Phase 3 clinical studies that evaluated efficacy and safety of MPA in gynecology. Those most frequently (>5%) reported adverse drug reactions were dysfunctional uterine bleeding (19%), headache (12%) and nausea (10%). (See Table 1.)


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100 mg: Oncology: The table as follows provides a listing of adverse drug reactions with frequency based on all-causality data from 1337 patients who received MPA in 4 pivotal studies that evaluated efficacy and safety of MPA for oncology indications. (See Table 2.)


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