Prometrium Side Effects
Generic name: progesterone
Medically reviewed by Drugs.com. Last updated on Oct 24, 2022.
Note: This document contains side effect information about progesterone. Some dosage forms listed on this page may not apply to the brand name Prometrium.
Common side effects of Prometrium include: abdominal cramps, dizziness, and headache. Other side effects include: anxiety, cough, diarrhea, fatigue, musculoskeletal pain, nausea, bloating, emotional lability, and irritability. Continue reading for a comprehensive list of adverse effects.
Applies to progesterone: oral capsules, parenteral injection, vaginal gel and inserts.
Side effects include:
Menstrual abnormalities (amenorrhea; breakthrough bleeding and/or spotting; changes in menstrual flow), weight changes, dizziness, headache, abdominal pain and/or distention, breast tenderness and/or pain, fatigue, musculoskeletal pain, joint pain.
Injection site pain.
For Healthcare Professionals
Applies to progesterone: compounding powder, intramuscular solution, oral capsule, topical cream, vaginal gel, vaginal insert, vaginal suppository.
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
Very common (10% or more): Headache (31%), somnolence (27%), dizziness (24%)
Uncommon (0.1% to 1%): Dysgeusia
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]
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]
Very common (10% or more): Hot flashes (11%)
Uncommon (0.1% to 1%): Hemorrhage
Rare (less than 0.1%): Thromboembolism or thrombus formation
Very common (10% or more): Abdominal pain (20%), abdominal bloating (12%)
Uncommon (0.1% to 1%): Flatulence, gastric dilatation
Very common (10% or more): Joint pain (20%), cramps NOS (15%), musculoskeletal pain (12%)
Postmarketing reports: Cleft lip, muscle cramp[Ref]
Common (1% to 10%): Coughing, upper respiratory tract infection
Frequency not reported: Shortness of breath
Common (1% to 10%): Night sweats
Uncommon (0.1% to 1%): Pruritus, acne
Very rare (less than 0.01%): Urticaria, chloasma
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
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]
Common (1% to 10%): Hyperglycemia
Common (1% to 10%): Breast carcinoma
Uncommon (0.1% to 1%): Rectal neoplasm
Frequency not reported: Blurred vision
Postmarketing reports: Diplopia, visual disturbance[Ref]
Uncommon (0.1% to 1%): Hypersensitivity reactions
Rare (less than 0.1%): Adrenal suppression or insufficiency[Ref]
Frequency not reported: Injection site reaction[Ref]
More about Prometrium (progesterone)
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- During pregnancy
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- Drug class: progestins
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Related treatment guides
1. Product Information. Prometrium (progesterone). Virtus Pharmaceuticals LLC. 2001.
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.
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.