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    Taking Charge of Your Fertility
    by Toni Weschler

    The Definitive Guide to Natural Birth Control and Pregnancy Achievement

    © 2001-2007
    Welcome to Our Depo-Provera Story

    This site was established March 10, 2001


    In five clinical studies of depo-subQ provera 104 involving 2,325 women (282 treated for up to 6 months, 1,780 treated for up to 1 year and 263 treated for up to 2 years), 9% of women discontinued treatment for adverse reactions. Among these 212 women, the most common reasons for discontinuation were:

    Uterine bleeding irregularities (35%, n=75)

    Increased weight (18%, n=39)

    Decreased libido (11%, n=23)

    Acne (10%, n=21)

    Injection site reactions (6%, n=12)

    Adverse reactions reported by 5% or more of all women in these clinical trials included:

    Headache (9%)

    Intermenstrual bleeding (7%)

    Increased weight (6%)

    Amenorrhea (6%)

    Injection site reactions (5%)

    Adverse reactions reported by 1% to <5% of all women in these clinical trials included:

    General disorders: fatigue, injection site pain

    Gastrointestinal disorders: abdominal distention, abdominal pain, diarrhea, nausea

    Infections: bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial

    Investigations: abnormal cervix smear

    Musculoskeletal, connective tissue, and bone disorders: arthralgia, back pain, limb pain

    Nervous system disorders: dizziness, insomnia

    Psychiatric disorders: anxiety, depression, irritability, decreased libido

    Reproductive system and breast disorders: breast pain, breast tenderness, menometrorrhagia, menorrhagia, menstruation irregular, uterine hemorrhage, vaginal hemorrhage

    Skin disorders: acne

    Vascular disorders: hot flushes

    Postmarketing Experience

    There have been rare cases of osteoporosis including osteoporotic fractures reported postmarketing in patients taking DEPO-PROVERA Contraceptive Injection. In addition, infrequent voluntary reports of anaphylaxis and anaphylactoid reaction have been received associated with use of Depo-Provera CI (150 mg).

    The following additional reactions have been reported with Depo-Provera Contraceptive Injection and may occur with use of depo-subQ provera 104:

    General disorders: asthenia, axillary swelling, chills, chest pain, fever, excessive thirst

    Blood and lymphatic system disorders: anemia, blood dyscrasia

    Cardiac disorders: tachycardia

    Gastrointestinal disorders: gastrointestinal disturbances, rectal bleeding

    Hepato-biliary disorders: jaundice

    Immune system disorders: allergic reaction

    Infections: genitourinary infections

    Investigations: decreased glucose tolerance

    Musculoskeletal, connective tissue, and bone disorders: loss of bone mineral density, scleroderma

    Neoplasms: breast cancer, cervical cancer

    Nervous system disorders: convulsions, facial palsy, fainting, paralysis, paresthesia, somnolence

    Psychiatric disorders: increased libido, nervousness

    Reproductive system and breast disorders: breast lumps, galactorrhea, nipple discharge or bleeding, oligomenorrhea, prevention of lactation, prolonged anovulation, unexpected pregnancy, uterine hyperplasia, vaginal cyst

    Respiratory disorders: asthma, dyspnea, hoarseness

    Skin disorders: angioedema, dry skin, increased body odor, melasma, pruritus, urticaria

    Vascular disorders: deep vein thrombosis, pulmonary embolus, thrombophlebitis


    No drug-drug interaction studies have been conducted with depo-subQ provera 104.

    Aminoglutethimide administered concomitantly with depo-subQ provera 104 may significantly decrease the serum concentrations of MPA.

    Laboratory Tests

    The pathologist should be advised of progestin therapy when relevant specimens are submitted. The physician should be informed that certain endocrine and liver function tests, and blood components may be affected by progestin therapy:

    (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol).

    (b) Plasma and urinary gonadotropin levels are decreased (e.g., LH, FSH).

    (c) SHBG concentrations are decreased.

    (d) T3-uptake values may decrease.

    (e) There may be small changes in coagulation factors.

    (f) Sulfobromophthalein and other liver function test values may be increased slightly.

    (g) There may be small changes in lipid profiles.