Progesterone

Generic name: progesterone (proe JESS te rone)
Brand name: First Progesterone MC10, Menopause Formula Progesterone, Prometrium
Drug class: Progestins

Progesterone is a naturally occurring hormone important for the regulation of ovulation and menstruation. Progesterone is produced in high amounts in females by the ovaries. It is also produced in smaller amounts by the adrenal glands both males and females.

Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. It is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Warnings

Do not use progesterone without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

You should not use progesterone if you have: abnormal vaginal bleeding, a history of breast cancer, liver disease, or if you have recently had a heart attack, stroke, or blood clot.

Progesterone should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

Some forms of this medication may contain peanut oil. Do not use this medicine without telling your doctor if you have a peanut allergy.

Before taking this medicine

You should not use progesterone if you are allergic to it, or if you have:

• abnormal vaginal bleeding that a doctor has not checked;
• a history of breast cancer;
• liver disease;
• a peanut allergy;
• if you are pregnant;
• if you have had a stroke, heart attack, or blood clot within the past year; or
• if you have recently had an incomplete miscarriage or "missed" abortion.

Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer.

To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, circulation problems;
• migraines;
• asthma;
• kidney disease;
• seizures or epilepsy;
• a history of depression; or
• risk factors for coronary artery disease (such as high blood pressure, diabetes, lupus, high cholesterol, family history of coronary artery disease, smoking, being overweight).

Do not use progesterone if you are pregnant. It could harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Progesterone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use progesterone?

Use progesterone exactly as it was prescribed for you. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take the capsule with a full glass of water. It is best to take the medicine at night because this medicine can make you dizzy or drowsy.

Apply progesterone cream to the skin as directed by your doctor.

Progesterone is sometimes used for only a short time, such as 10 to 12 days during each menstrual cycle. Follow your doctor's dosing instructions very carefully.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using progesterone.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than one dose of this medication.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using progesterone?

Progesterone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Progesterone side effects

Get emergency medical help if you have signs of an allergic reaction to progesterone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• unusual vaginal bleeding;
• pain or burning when you urinate;
• a breast lump;
• sudden vision problems, severe headache or pain behind your eyes;
• symptoms of depression (sleep problems, weakness, mood changes);
• severe dizziness or drowsiness, spinning sensation, confusion, shortness of breath;
• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
• signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Common progesterone side effects may include:

• drowsiness, dizziness;
• breast pain;
• mood changes;
• headache;
• constipation, diarrhea, heartburn;
• bloating, swelling in your hands or feet;
• joint pain;
• hot flashes; or
• vaginal discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly reported side effects of progesterone include: abdominal cramps, depression, 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.

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.

Side effects requiring immediate medical attention

Along with its needed effects, progesterone 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

Side effects not requiring immediate medical attention

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

What other drugs will affect progesterone?

There may be other drugs that can interact with progesterone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.