Prometrium Side Effects

Generic name: progesterone

Medically reviewed by Drugs.com. Last updated on Oct 23, 2024.

Note: This document provides detailed information about Prometrium Side Effects associated with progesterone. Some dosage forms listed on this page may not apply specifically to the brand name Prometrium.

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

Important warnings This medicine can cause some serious health issues

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 side effects

• chest pain
• chills
• cold or flu-like symptoms
• cough or hoarseness
• fever
• problems with urination

Less common side effects

• clear or bloody discharge from the nipple
• dimpling of the breast skin
• inverted nipple
• lump in the breast or under the arm
• persistent crusting or scaling of the nipple
• redness or swelling of the breast
• sore on the skin of the breast that does not heal

Incidence not known

• abdominal or stomach pain
• bloating
• blurred vision
• change in vaginal discharge
• clay-colored stools
• cleft lip or palate
• confusion
• constipation
• darkened urine
• diarrhea
• difficult or labored breathing
• difficulty with swallowing
• difficulty with walking
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• headache
• hives
• indigestion
• irregular heartbeat
• irritation
• itching
• joint pain, stiffness, or swelling
• lightheadedness
• loss of appetite
• nausea
• nervousness
• noisy breathing
• numbness or tingling in the face, arms, or legs
• pain or feeling of pressure in the pelvis
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rash
• redness of the skin
• shortness of breath
• slow heartbeat
• spontaneous abortion
• stomach or pelvic discomfort, aching, or heaviness
• sweating
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• trouble speaking, thinking, or walking
• unpleasant breath odor
• unusual tiredness or weakness
• vaginal bleeding
• vomiting
• vomiting of blood
• wheezing
• yellow eyes or skin

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 side effects

• breast pain or tenderness
• depression
• muscle or joint pain
• white or brownish vaginal discharge
• worry

Incidence not known

• attack, assault, or force
• blurred or loss of vision
• change in walking and balance
• changes in behavior
• changes in patterns and rhythms of speech
• choking
• clumsiness or unsteadiness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased awareness or responsiveness
• difficulty with moving
• disturbed color perception
• double vision
• drowsiness
• extreme dizziness or drowsiness
• feeling drunk
• feeling of constant movement of self or surroundings
• feeling of unreality
• hair loss or thinning of the hair
• halos around lights
• hearing loss
• hives or welts
• longer or heavier menstrual periods
• loss of consciousness
• muscle cramps
• muscle stiffness
• night blindness
• normal menstrual bleeding occurring earlier, possibly lasting longer than expected
• overbright appearance of lights
• redness of the skin
• relaxed and calm
• sensation of spinning
• sense of detachment from self or body
• severe sleepiness
• sleepiness
• slurred speech
• swollen tongue
• thoughts of killing oneself
• tunnel vision
• weight changes

For healthcare professionals

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

Genitourinary adverse events

• 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]

Frequently asked questions

• What are my birth control options and how effective are they?

Further information

Prometrium side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer