Applies to medroxyprogesterone: oral tablet. Other dosage forms:

• suspension

Serious side effects of Medroxyprogesterone

Along with its needed effects, medroxyprogesterone 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 Medroxyprogesterone

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]