In the largest clinical trial with DEPO-PROVERA CI, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of DEPO-PROVERA CI.

The following adverse reactions were reported by more than 5% of subjects: Menstrual irregularities (bleeding or amenorrhea, or both)

Abdominal pain or discomfort
Weight changes
Dizziness Headache
Asthenia (weakness or fatigue)
Nervousness

Adverse reactions reported by 1% to 5% of subjects using DEPO-PROVERA Contraceptive Injection were:

Decreased libido or anorgasmia
Pelvic pain
Backache
Breast pain
Leg cramps
No hair growth or alopecia
Depression
Bloating
Nausea
Rash
Insomnia
Edema
Leukorrhea
Hot flashes
Acne
Arthralgia
Vaginitis

Events reported by fewer than 1% of subjects included: galactorrhea, melasma, chloasma, convulsions, changes in appetite, gastrointestinal disturbances, jaundice, genitourinary infections, vaginal cysts, dyspareunia, paresthesia, chest pain, pulmonary embolus, allergic reactions, anemia, drowsiness, syncope, dyspnea and asthma, tachycardia, fever, excessive sweating and body odor, dry skin, chills, increased libido, excessive thirst, hoarseness, pain at injection site, blood dyscrasia, rectal bleeding, changes in breast size, breast lumps or nipple bleeding, axillary swelling, breast cancer, prevention of lactation, sensation of pregnancy, lack of return to fertility, paralysis, facial palsy, scleroderma, osteoporosis, uterine hyperplasia, cervical cancer, varicose veins, dysmenorrhea, hirsutism, unexpected pregnancy, thrombophlebitis, deep vein thrombosis.

Postmarketing Experience

There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking Depo-Provera CI. In addition, there have been voluntary reports of anaphylaxis and anaphylactoid reaction associated with the use of Depo-Provera CI.

Aminoglutethimide administered concomitantly with the DEPO-PROVERA CI may significantly depress the serum concentrations of medroxyprogesterone acetate.¹² Users of DEPO-PROVERA CI should be warned of the possibility of decreased efficacy with the use of this or any related drugs.

REFERENCES

12. Van Deijk WA, Biljham GH, Mellink WAM, Meulenberg PMM. Influence of aminoglutethimide on plasma levels of medroxyprogesterone acetate: its correlation with serum cortisol. Cancer Treatment Reports. 1985; 69:1, 85-90.

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