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.

Summary

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.

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]

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.

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