Note: This document contains side effect information about medroxyprogesterone. Some dosage forms listed on this page may not apply to the brand name Depo-Provera.
Applies to medroxyprogesterone: oral tablet. Other dosage forms:
- suspension
Warning
Oral route (Tablet)
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Studies have demonstrated an increased risk of DVT, pulmonary embolism, stroke and myocardial infarction in postmenopausal women during treatment with daily oral conjugated estrogens combined with medroxyPROGESTERone acetate, relative to placebo. Studies have also demonstrated estrogen plus progestin increases risk of developing probable dementia in postmenopausal women 65 years of age or older. It is unknown whether this finding applies to younger postmenopausal women. An increased risk of invasive breast cancer has also been found in studies. In the absence of comparable data, these risks should be assumed to be similar for other doses of estrogens and progestins, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Serious side effects of Depo-Provera
Along with its needed effects, medroxyprogesterone (the active ingredient contained in Depo-Provera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking medroxyprogesterone:
Incidence not known
- Abdominal or stomach pain
- absent, missed, or irregular menstrual periods
- anxiety
- blurred vision
- breast pain or tenderness
- changes in skin color
- chills
- clay-colored stools
- cough
- dark urine
- decrease in amount of urine
- diarrhea
- difficulty swallowing
- dizziness or lightheadedness
- eye pain
- fainting
- fast heartbeat
- fever
- headache
- hives or welts, itching, redness, swelling, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- menstrual changes
- nausea
- noisy, rattling breathing
- pain in the chest, groin, or legs, especially the calves
- pain, tenderness, or swelling of the foot or leg
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe, sudden headache
- shortness of breath
- slurred speech
- stopping of menstrual bleeding
- sudden loss of coordination
- sudden, severe weakness or numbness in the arm or leg
- sudden, unexplained shortness of breath
- swelling of the fingers, hands, feet, or lower legs
- troubled breathing at rest
- unexpected or excess milk flow from the breasts
- unpleasant breath odor
- unusual tiredness or weakness
- vaginal bleeding or spotting
- vision changes
- vomiting of blood
- weight gain
- yellow eyes or skin
Other side effects of Depo-Provera
Some side effects of medroxyprogesterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Blemishes on the skin
- discouragement
- feeling sad or empty
- hair loss, thinning of hair
- increased hair growth, especially on the face
- irritability
- lack of appetite
- loss of interest or pleasure
- nervousness
- pimples
- sleepiness or unusual drowsiness
- tiredness
- trouble concentrating
- trouble sleeping
- weight changes
For Healthcare Professionals
Applies to medroxyprogesterone: compounding powder, intramuscular suspension, oral tablet, subcutaneous suspension.
Gastrointestinal
Very common (10% or more): Abdominal pain/discomfort (up to 11.2%)
Common (1% to 10%): Nausea, bloating, abdominal distention, diarrhea, vomiting, constipation
Uncommon (0.1% to 1%): Dry mouth
Postmarketing reports: Gastrointestinal disturbances, rectal bleeding[Ref]
Genitourinary
Very common (10% or more): Amenorrhea (up to 68%), bleeding (up to 57.3%), uterine bleeding irregularities (up to 35%)
Common (1% to 10%): Dysmenorrhea, leukorrhea, vaginitis, intermenstrual bleeding, urinary tract infection, vaginal candidiasis, vaginitis, vaginitis bacterial, abnormal cervix smear, metrorrhagia, menometrorrhagia, menstruation irregular, vaginal hemorrhage, erectile dysfunction, genitourinary tract infection, pelvic pain, dyspareunia
Frequency not reported: Uterine cervical erosions, cervical discharge, vulvovaginal dryness, premenstrual syndrome, vaginal cyst, ovarian cyst, lack of return to fertility, sensation of pregnancy
Postmarketing reports: Unexpected pregnancy, uterine hyperplasia, oligomenorrhea, prolonged anovulation[Ref]
Metabolic
Very common (10% or more): Increase weight (up to 37%)
Common (1% to 10%): Increased appetite, decreased appetite
Uncommon (0.1% to 1%): Diabetes mellitus exacerbated, hypercalcemia, fluid retention
Frequency not reported: Elevations of serum calcium and potassium levels, exacerbation of diabetes mellitus
Postmarketing reports: Decreased glucose tolerance, changes in appetite, excessive thirst[Ref]
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.[Ref]
Nervous system
Very common (10% or more): Nervousness (10.8%)
Common (1% to 10%): Dizziness
Rare (less than 0.1%): Cerebral infarction, somnolence
Frequency not reported: Loss of concentration, adrenergic-like effects, migraine, seizure, VII th nerve paralysis, syncope
Postmarketing reports: Paralysis, facial palsy, paresthesia, drowsiness[Ref]
Other
Very common (10% or more): Headache (up to 16.5%)
Common (1% to 10%): Asthenia, fatigue, edema /fluid retention, breast pain, breast tenderness
Frequency not reported: Chills, fever, vertigo, breast atrophy, breast mass, nipple exudate bloody, breast enlargement
Postmarketing reports: Changes in breast size[Ref]
Cardiovascular
The majority of cases of thromboembolic disease during hormonal therapy have been attributed to estrogens and not to progestogens. However, it has been demonstrated that this drug, at least at high doses, can produce a hypercoagulable state. Whether or not this contributes to the development of thrombotic events remains unknown.[Ref]
Common (1% to 10%): Hot flashes
Uncommon (0.1% to 1%): Cardiac failure congestive, thrombophlebitis
Rare (less than 0.1%): Myocardial infarction, embolism, thrombosis, blood pressure increased
Frequency not reported: Tachycardia, palpitations
Postmarketing reports: Deep vein thrombosis, varicose veins[Ref]
Dermatologic
Common (1% to 10%): Acne, no hair growth/alopecia, rash, hyperhidrosis
Uncommon (0.1% to 1%): Hirsutism, urticaria, pruritus, chloasma
Frequency not reported: Lipodystrophy acquired, dermatitis, ecchymosis, scleroderma, skin striae, erythema multiforme, erythema nodosum
Postmarketing reports: Axillary swelling, excessive sweating and body odor, dry skin, melasma[Ref]
Musculoskeletal
Common (1% to 10%): Leg cramps, arthralgia, back pain, limb pain, pain in extremity
Uncommon (0.1% to 1%): Muscle spasms
Frequency not reported: Gluteal infiltration and abscess formation
Postmarketing reports: Chest pain, osteoporosis including osteoporotic fractures, loss of bone mineral density, scleroderma[Ref]
Psychiatric
Common (1% to 10%): Depression, insomnia, anxiety, irritability, decreased libido
Uncommon (0.1% to 1%): Euphoria, changes in libido
Rare (less than 0.1%): Confusion
Frequency not reported: Anorgasmia, emotional disturbance, affective disorder,
Postmarketing reports: Increased libido[Ref]
Respiratory
Common (1% to 10%): Bronchitis, influenza, nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection
Uncommon (0.1% to 1%): Pulmonary embolism
Frequency not reported: Dysphonia
Postmarketing reports: Dyspnea, asthma, hoarseness[Ref]
Endocrine
Uncommon (0.1% to 1%): Corticoid-like effects
Frequency not reported: Cushingoid syndrome, galactorrhea
Postmarketing reports: Prevention of lactation with or without hyperprolactinemia[Ref]
Hepatic
Uncommon (0.1% to 1%): Abnormal hepatic function, jaundice cholestatic
Postmarketing reports: Abnormal liver function test, abnormal hepatic enzyme[Ref]
Hypersensitivity
Frequency not reported: Allergic reactions including angioedema, anaphylactic reaction, anaphylactoid reaction[Ref]
Immunologic
Frequency not reported: White blood cell count increased, platelet count increased
Postmarketing reports: Anemia, blood dyscrasia[Ref]
Local
Frequency not reported: Injection site abscess, injection site infection, injection site nodule/lump, injection site pain/tenderness, injection site persistent atrophy/indentation/dimpling[Ref]
Ocular
Frequency not reported: Retinal embolism and thrombosis, cataract diabetic, visual impairment[Ref]
Renal
Frequency not reported: Glycosuria[Ref]
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.[Ref]
Postmarketing reports: Cervical cancer, breast cancer, endometrial hyperplasia, breast lumps or nipple bleeding, nipple discharge[Ref]
