Skip to main content

Prometrium Side Effects

Generic name: progesterone

Medically reviewed by Drugs.com. Last updated on Oct 23, 2023.

Note: This document contains side effect information about progesterone. Some dosage forms listed on this page may not apply to the brand name Prometrium.

Applies to progesterone: oral capsule, oral capsule liquid filled.

Warning

Oral route (Capsule, Liquid Filled)

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) have been reported with estrogen plus progestin therapy. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older has also been reported. Risks should be assumed to be similar for other doses, combinations, and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration possible.

Serious side effects of Prometrium

Along with its needed effects, progesterone (the active ingredient contained in Prometrium) 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 progesterone:

More common

Less common

Incidence not known

Other side effects of Prometrium

Some side effects of progesterone 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:

More common

Incidence not known

For Healthcare Professionals

Applies to progesterone: compounding powder, intramuscular solution, oral capsule, topical cream, vaginal gel, vaginal insert, vaginal suppository.

Genitourinary

Very common (10% or more): Breast enlargement (40%), breast tenderness (27%), perineal pain female (17%), breast pain (16%), nocturia (13%), urinary problems (11%), vaginal discharge (11%)

Common (1% to 10%): Ovarian hyperstimulation syndrome, breast pain, vaginal dryness, pruritus genital, uterine spasm, vaginal bleeding, altered periods, amenorrhea, intercurrent bleeding

Uncommon (0.1% to 1%): Vulvovaginal disorders, vaginal mycosis, breast disorders, pollakiuria, incontinence, ovarian enlargement, pelvic pain, vulvovaginal pruritus, galactorrhea

Frequency not reported: Vaginal irritation, vaginal burning, vaginal discomfort, fatty discharge, changes in cervical erosion and secretions

Postmarketing reports: Hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion[Ref]

Nervous system

Very common (10% or more): Headache (31%), somnolence (27%), dizziness (24%)

Uncommon (0.1% to 1%): Dysgeusia

Frequency not reported: Extreme dizziness and/or drowsiness, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, insomnia

Postmarketing reports: Convulsion, depressed consciousness, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack, abnormal gait, difficulty walking[Ref]

Psychiatric

Very common (10% or more): Emotional lability (23%), depression (19%), sleep disorder (18%), nervousness (16%), libido decreased (10%)

Common (1% to 10%): Worry

Uncommon (0.1% to 1%): Mood altered

Postmarketing reports: Aggression, depersonalization, disorientation, suicidal ideation[Ref]

Cardiovascular

Very common (10% or more): Hot flashes (11%)

Uncommon (0.1% to 1%): Hemorrhage

Rare (less than 0.1%): Thromboembolism or thrombus formation

Postmarketing reports: Circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosis), hypertension, hypotension, tachycardia[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (20%), abdominal bloating (12%)

Common (1% to 10%): Nausea/vomiting, diarrhea, abdominal distension, constipation

Uncommon (0.1% to 1%): Flatulence, gastric dilatation

Postmarketing reports: Acute pancreatitis, dysphagia, swollen tongue, cleft palate[Ref]

Musculoskeletal

Very common (10% or more): Joint pain (20%), cramps NOS (15%), musculoskeletal pain (12%)

Common (1% to 10%): Back pain, arthralgia, myalgia

Postmarketing reports: Cleft lip, muscle cramp[Ref]

Respiratory

Common (1% to 10%): Coughing, upper respiratory tract infection

Frequency not reported: Shortness of breath

Postmarketing reports: Choking, dyspnea, asthma, throat tightness[Ref]

Dermatologic

Common (1% to 10%): Night sweats

Uncommon (0.1% to 1%): Pruritus, acne

Very rare (less than 0.01%): Urticaria, chloasma

Frequency not reported: Itching, hirsutism

Postmarketing reports: Alopecia, face edema[Ref]

Other

Very common (10% or more): Post oocyte retrieval pain (28%), viral infection (12%), hot flashes (11%)

Common (1% to 10%): Fatigue, pain, chest pain, swelling of hands and feet, breast excisional biopsy

Uncommon (0.1% to 1%): Peripheral edema, feeling cold, feeling of body temperature change, discomfort, weight increased

Frequency not reported: Feeling drunk, pyrexia

Postmarketing reports: Feeling abnormal, tinnitus, weight decreased[Ref]

Hepatic

Common (1% to 10%): Cholecystectomy

Uncommon (0.1% to 1%): Cholestatic jaundice

Postmarketing reports: Cholestasis, cholestatic hepatitis, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase, aspartate aminotransferase, and gamma-glutamyl transferase increases), jaundice[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia

Postmarketing reports: Blood glucose increased[Ref]

Oncologic

Common (1% to 10%): Breast carcinoma

Uncommon (0.1% to 1%): Rectal neoplasm

Postmarketing reports: Endometrial carcinoma[Ref]

Ocular

Frequency not reported: Blurred vision

Postmarketing reports: Diplopia, visual disturbance[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions

Postmarketing reports: Anaphylactic reaction[Ref]

Endocrine

Rare (less than 0.1%): Adrenal suppression or insufficiency[Ref]

Local

Frequency not reported: Injection site reaction[Ref]

References

1. Product Information. Prometrium (progesterone). Virtus Pharmaceuticals LLC. 2001;PROD.

2. Product Information. Crinone (progesterone). Actavis U.S. (Alpharma USPD). 2004.

3. Cerner Multum, Inc. UK Summary of Product Characteristics.

4. Cerner Multum, Inc. Australian Product Information.

5. Product Information. Endometrin (progesterone). Ferring Pharmaceuticals Inc. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.