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Prometrium

Generic Name: Progesterone Capsules (proe JES ter one)
Brand Name: Prometrium
Easy-to-read patient leaflet for Prometrium. Includes indications, proper use, special instructions, precautions, and possible side effects.

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Drug Information:
This is not a list of all drugs or health problems that interact with Prometrium (Progesterone capsules). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Prometrium (Progesterone capsules) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Use Prometrium (Progesterone capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely. Learn more

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Prometrium Side Effects

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

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

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.

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

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

Less common

  • 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

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

  • 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

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

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

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

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

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

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

Respiratory

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

Frequency not reported: Shortness of breath

Postmarketing reports: Choking, dyspnea, asthma, throat tightness

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

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

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

Metabolic

Common (1% to 10%): Hyperglycemia

Postmarketing reports: Blood glucose increased

Oncologic

Common (1% to 10%): Breast carcinoma

Uncommon (0.1% to 1%): Rectal neoplasm

Postmarketing reports: Endometrial carcinoma

Ocular

Frequency not reported: Blurred vision

Postmarketing reports: Diplopia, visual disturbance

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions

Postmarketing reports: Anaphylactic reaction

Endocrine

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

Local

Frequency not reported: Injection site reaction

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Prometrium (www.drugs.com/prometrium.html).