SIDE EFFECTS
In the largest clinical trial with DEPO-PROVERA Contraceptive
Injection, 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 Contraceptive
Injection.
The following adverse reactions were reported by more
than 5% of subjects:
Menstrual irregularities
(bleeding or amenorrhea, or both)
Weight changes
Headache
Nervousness
Abdominal pain or discomfort
Dizziness
Asthenia (weakness or fatigue)
Adverse reactions reported by 1% to 5% of subjects using
DEPO-PROVERA Contraceptive Injection were:
Decreased libido or anorgasmia
Backache
Leg cramps
Depression
Nausea
Insomnia
Leukorrhea
Acne
Vaginitis
Pelvic pain
Breast pain
No hair growth or alopecia
Bloating
Rash
Edema
Hot flashes
Arthralgia
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.
In addition, voluntary reports have been received of
anaphylaxis and anaphylactoid reaction with use of DEPO-PROVERA
Contraceptive Injection.
DRUG INTERACTIONS
Aminoglutethimide administered concomitantly with the
DEPO-PROVERA Contraceptive Injection may significantly
depress the serum concentrations of medroxyprogesterone
acetate. 12 Users of DEPO-PROVERA Contraceptive Injection
should be warned of the possibility of decreased efficacy
with the use of this or any related drugs.
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