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.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects. Pelvic exam, breast exam, and mammogram (breast x-ray) may be needed to check for unwanted effects, unless your doctor tells you otherwise.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Stop using this medicine and check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves; difficulty with breathing; a sudden, severe headache; slurred speech; a sudden, unexplained shortness of breath; a sudden loss of coordination; or vision changes while using this medicine.

There is a very slight chance that this medicine could increase the risk of breast cancer and endometrial (lining of the uterus) cancer in some women. Talk to your doctor about this risk. Make sure your doctor knows if anyone in your family has had breast cancer or endometrial cancer.

Using large doses of this medicine over a long period of time and using it with an estrogen medicine may increase your risk of heart attack, stroke, blood clots, or dementia. Talk with your doctor about these risks.

Your risk of heart disease or stroke from this medicine is higher if you smoke. Your risk is also increased if you have diabetes or high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Tell the medical doctor or dentist in charge that you are using this medicine before any kind of surgery (including dental surgery) or emergency treatment. Your doctor will decide whether you should continue using this medicine.

Stop using this medicine and check with your doctor immediately if sudden loss of vision or any other change in vision occurs while you are using this medicine. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

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:

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:

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]

See also:

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