Depo-Provera Adverse Reactions

CONTRACEPTION - Intramuscular (IM) Formulation: The table as follows provides a listing of adverse drug reactions with frequency based on all-causality data from clinical studies that enrolled more than 4200 women who received DMPA for contraception for up to 7 years. Those most frequently (>5%) reported adverse drug reactions were weight increased (69%), weight decreased (25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), and decrease in libido (6%). (See Table 4.)

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Additional Adverse Events Reported During Post-marketing Experience: Intramuscular Formulations: In post-marketing experience, there have been rare cases of osteoporosis including osteoporotic fractures reported in patients taking DMPA IM.
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 DMPA in gynecology. Those most frequently (>5%) reported adverse drug reactions were dysfunctional uterine bleeding (19%), headache (12%) and nausea (10%). (See Table 5.)

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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 6.)

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