Menopause Formula Progesterone

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.

Do not use if you are pregnant.

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.

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.

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.

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

Applies to progesterone: oral capsule, oral capsule liquid filled

Along with its needed effects, progesterone (the active ingredient contained in Menopause Formula 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:

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

• 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

• 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:

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

• 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

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]

Some side effects of Menopause Formula Progesterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.