First Progesterone MC10

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.

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 progesterone capsule with a full glass of water. It is best to take the medicine at night because progesterone 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 progesterone.

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

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

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.

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 First Progesterone MC10 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.