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Provera (Medroxyprogesterone Acetate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.



REPORTS OF SUSPECTED PROVERA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Provera. The information is not vetted and should not be considered as verified clinical evidence.

Possible Provera side effects / adverse reactions in 47 year old female

Reported by a consumer/non-health professional from Norway on 2011-10-21

Patient: 47 year old female

Reactions: Transient Ischaemic Attack, Convulsion

Adverse event resulted in: hospitalization

Suspect drug(s):
Provera
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Start date: 2008-01-01

Provera
    Dosage: daily
    Administration route: Oral
    Indication: Endometriosis
    Start date: 1992-01-01



Possible Provera side effects / adverse reactions in 49 year old female

Reported by a consumer/non-health professional from United States on 2011-11-04

Patient: 49 year old female weighing 72.6 kg (159.7 pounds)

Reactions: Breast Cancer, Asthma, Pancreatitis, Gallbladder Disorder

Adverse event resulted in: hospitalization, disablity

Suspect drug(s):
Estraderm
    Dosage: estraderm 1 weekly patch daily
    Indication: Oophorectomy

Provera
    Dosage: provera 1 daily oral
    Administration route: Oral



Possible Provera side effects / adverse reactions in 59 year old female

Reported by a consumer/non-health professional from Canada on 2011-11-16

Patient: 59 year old female

Reactions: Abasia, Vaginal Haemorrhage

Suspect drug(s):
Provera
    Dosage: unk
    Administration route: Oral
    Indication: OFF Label USE
    Start date: 2008-04-01

Provera
    Indication: Hot Flush



See index of all Provera side effect reports >>

Drug label data at the top of this Page last updated: 2009-08-13

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