Provera Side Effects
Generic Name: Medroxyprogesterone
Please note - some side effects for Provera 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).
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For the consumer For the professional
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Side Effects of Provera - for the consumer
Provera
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 Provera:
Seek medical attention right away if any of these SEVERE side effects occur when using Provera: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.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; depression; lumps in the breast or under the armpits; 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; tenderness, pain, or swelling of the calf; weakness, numbness, or pain in the arms or legs; yellowing of the skin or eyes.
For the professional
Provera
See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The following adverse reactions have been reported in women taking progestins, including Provera tablets, without concomitant estrogens treatment:
1. Genitourinary system
Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions.
2. Breasts
Breast tenderness, mastodynia or galactorrhea has been reported.
3. Cardiovascular
Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported.
4. Gastrointestinal
Nausea, cholestatic jaundice.
5. Skin
Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported.
6. Eyes
Neuro-ocular lesions, e.g., retinal thrombosis and optic neuritis.
7. Central nervous system
Mental depression, insomnia, somnolence, dizziness, headache, nervousness.
8. Miscellaneous
Hypersensitivity reactions (e.g., anaphylaxis & anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance.
The following additional adverse reactions have been reported with estrogen and/or progestin therapy.
1. Genitourinary system
Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain, increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts
Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer.
3. Cardiovascular
Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure.
4. Gastrointestinal
Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas.
5. Skin
Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash.
6. Eyes
Retinal vascular thrombosis, intolerance to contact lenses.
7. Central nervous system
Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia.
8. Miscellaneous
Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaplylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.
TopMore resources:
Depo-Provera Injectable Suspension
Provera - Includes detailed dosage instructions.
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