Depo-SubQ Provera 104 Side Effects

Generic Name: medroxyprogesterone

Please note - some side effects for Depo-SubQ Provera 104 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Depo-SubQ Provera 104 - for the Consumer

Depo-subQ provera 104 Injectable Suspension (subcutaneous)

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Depo-subQ provera 104 Injectable Suspension (subcutaneous):

Acne; changes in menstrual flow, including breakthrough bleeding, spotting, or missed periods; dizziness; drowsiness; fever; headache; hot flashes; nausea; nervousness; pain; rash; sleeplessness; stomach pain; weakness; weight gain or loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood clots; chest pain; depression; partial or complete loss of vision or changes in vision; shortness of breath; slurred speech; sudden loss of coordination; sudden or severe headache; swelling of fingers or ankles; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.

Depo-SubQ Provera 104 Side Effects - for the Professional

Depo-SubQ Provera 104

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

Side Effects by Body System

Endocrine

Endocrine side effects have included breast tenderness, galactorrhea with or without hyperprolactinemia, prevention of lactation, hirsutism, and Cushing's syndrome.

Cushing's syndrome is uncommon and appears to be associated with a long duration of therapy and moderate to high doses of medroxyprogesterone. Doses used for hormonal replacement therapy and for long-term contraception are not associated with Cushing's syndrome.

Medroxyprogesterone has mild glucocorticoid activity. In cases of medroxyprogesterone-induced Cushing's syndrome, low cortisol and adrenocorticotrophic hormone (ACTH) levels with a reduced pituitary-adrenal reserve have been documented. Acute adrenal insufficiency may ensue following withdrawal of medroxyprogesterone.

Metabolic

Weight gain is more frequently encountered than weight loss during medroxyprogesterone therapy. In women using intramuscular medroxyprogesterone for contraception, the mean weight gain after one year of therapy is 2.5 kg. After two, four, and six years, patients gain a mean of 3.7, 6.3, and 7.5 kg, respectively.

Data regarding the effect of medroxyprogesterone on lipid profiles have been conflicting. Some studies report possible negative effects on lipid profiles while others have documented a reduction in total and low-density lipoprotein cholesterol and an increase in high-density lipoprotein cholesterol levels.

Metabolic side effects have included weight changes (increases and decreases), glucose intolerance, and changes in serum cholesterol concentrations.

Genitourinary

Withdrawal bleeding is a common complaint among postmenopausal women receiving sequential (10 to 14 days per cycle) medroxyprogesterone therapy. In postmenopausal women receiving continuous medroxyprogesterone and estrogen therapy, 75% or more are amenorrheic by one year of therapy.

In women receiving medroxyprogesterone for contraception, more than 50% are amenorrheic by one year of therapy.

In women on estrogen replacement therapy, the addition of medroxyprogesterone or other progestin for at least 10 to 14 days of each cycle significantly reduces the risk of endometrial hyperplasia and, thus, the risk of endometrial carcinoma. Low-dose continuous medroxyprogesterone therapy also reduces the risk of endometrial hyperplasia associated with the use of unopposed estrogen.

In patients in whom abnormal bleeding persists or is severe, the possibility of an organic pathology should be considered and ruled out.

Genitourinary side effects have been relatively common and included primarily menstrual changes such as amenorrhea, irregular bleeding, spotting, and heavy bleeding. Vaginal cysts, dyspareunia, and changes in cervical erosion and secretions have also been reported. While endometrial hyperplasia has been reported, medroxyprogesterone tended to have a favorable effect on the endometrium. Changes in libido and anorgasmia have also occurred.

Oncologic

A significant increase in the incidence of breast cancer in beagle dogs in addition to an apparent increase in the incidence of endometrial cancer in rhesus monkeys was noted in early animal carcinogenicity studies.

International long-term studies designed to assess the risk of medroxyprogesterone in humans, sponsored by the World Health Organization, failed to find an increased risk of cancer in users of medroxyprogesterone. Overall, there was no significant increase in the risk of breast cancer, cervical cancer, or epithelial ovarian cancer. Data from these studies did, however, support a significant (8-fold) reduction in the incidence of endometrial cancer among medroxyprogesterone users.

A study from New Zealand has suggested that women taking depot medroxyprogesterone acetate may be at higher risk for breast cancer during the first 5 years, but therapy for more than 5 years confers no increased risk of breast cancer.

Oncologic side effects possibly associated with medroxyprogesterone have been the topic of considerable debate. Data from some animal studies suggested an increased risk of breast and endometrial cancer. The current consensus is that the carcinogenic potential of medroxyprogesterone is no greater than that of other hormonal contraceptives.

Cardiovascular

The majority of cases of thromboembolic disease during hormonal therapy have been attributed to estrogens and not to progestins. However, it has been demonstrated that medroxyprogesterone, at least at high doses, can produce a hypercoagulable state. Whether or not this contributes to the development of thrombotic events remains unknown.

Because medroxyprogesterone can cause edema, it should be used cautiously in patients with underlying disease (like migraine headaches, asthma, heart disease, renal dysfunction, or seizure disorders) which may be exacerbated by edema or fluid retention.

Cardiovascular side effects have included thromboembolic disorders such as thrombophlebitis, deep vein thrombosis, pulmonary embolism, cerebrovascular accidents, and retinal thrombosis. In addition, edema, hypertension, tachycardia, and syncope have been noted.

Musculoskeletal

Musculoskeletal side effects have included changes in bone mineral density and leg cramps.

Reductions in bone mineral density and osteoporosis have been attributed to medroxyprogesterone. Such effects are probably due to medroxyprogesterone-induced estrogen deficiency.

Conflicting data concerning the effects of medroxyprogesterone on bone mineral density have been reported.

In one study, women 25 to 51 years of age receiving medroxyprogesterone 150 mg intramuscularly every three months for five or more years for long-term contraception had a reduction in bone mineral density compared with premenopausal controls. However, bone mineral density in the treatment group was still significantly greater than that observed in postmenopausal controls.

A study of 200 women who received medroxyprogesterone 150 mg intramuscularly every three months for a median duration of 12 years (range 2 to 26 years) reported that bone density was significantly reduced in medroxyprogesterone users. However, bone mineral density in women starting depot medroxyprogesterone after the age of 20 years and using it for 15 or fewer years was greater than the remainder of the cohort.

A study to determine the potential for postmenopausal fracture due to residual effects of depot medroxyprogesterone in former users reported the risk to be small and unlikely to have substantial impact in postmenopausal women. No significant differences in bone density were found, however, women who had used depot medroxyprogesterone for >2 yeas had a trend toward lower bone densities.

Bone density in 185 women receiving long-term depot medroxyprogesterone for a mean of 5 years (range of 1-16 years) was only minimally below the normal population despite decreased estrogen levels.

Dermatologic

Dermatologic side effects have included acne, reduced hair growth, alopecia, melasma, chloasma, rash, excessive sweating, dry skin, scleroderma, erythema multiforme, and erythema nodosum.

Nervous system

Nervous system side effects have included headache, asthenia, dizziness, depression, somnolence, and insomnia. Paresthesias, convulsions, and facial palsy have been reported although causality is unknown.

Gastrointestinal

Gastrointestinal side effects have occurred in up to 5% of patients and included nausea, abdominal pain, bloating, and anorexia.

Hepatic

Hepatic side effects have included elevations in liver function tests, jaundice, cholestatic jaundice, and cholelithiasis.

Hematologic

Hematologic side effects have included rare reports of hypercoagulability with and without thromboembolic activity.

Hypersensitivity

Hypersensitivity side effects have been uncommon but have included urticaria, angioneurotic edema, and anaphylaxis or anaphylactoid reactions.

Local

Local side effects associated with intramuscular administration of medroxyprogesterone have included pain, change in skin color, residual lumps, and sterile abscesses at the injection site.

Ocular

Ocular side effects have included visual disturbances such as sudden loss of vision (partial or complete), sudden onset of proptosis, diplopia, or migraine have been reported. Therapy should be withdrawn in the presence of papilledema or retinal vascular lesions.

Psychiatric

Psychiatric side effects have included dysphoric symptoms similar to premenstrual syndrome (PMS).

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