Prometrium Side Effects

Generic Name: Progesterone

Please note - some side effects for Prometrium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prometrium - for the consumer

Prometrium

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prometrium:

Bloating; breast tenderness; diarrhea; dizziness; drowsiness; dry mouth; fluid retention; headache; heartburn; irritability; muscle pain; nausea; stomach pain or cramping; tiredness; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; bulging eyes; coughing up blood; dark urine; double vision; fainting; gallstones; mental or mood changes (eg, depression or worry); migraine; numbness of an arm or leg; pain or lumps in the breast; one-sided weakness; pounding in the chest; seizures or tremors; severe stomach pain; speech problems; stomach pain, swelling, or tenderness; sudden, severe chest pain or numbness; sudden, severe headache; sudden, severe vomiting, dizziness, or fainting; sudden sharp pain or swelling in the calf or leg; sudden shortness of breath; swelling of the ankles or fingers; vision problems or changes (including sudden, partial, or full loss of vision); yellowing of the eyes or skin.

For the professional

Prometrium

See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximate rates.

Endometrial Protection:Table 8 lists adverse experiences which were reported in ≥2% of patients (regardless of relationship to treatment) who received cyclic Prometrium Capsules, 200 mg daily (12 days per calendar month cycle) with daily 0.625 mg conjugated estrogen, in a multicenter, randomized, double-blind, placebo-controlled clinical trial in 875 postmenopausal women.

Secondary Amenorrhea:Table 9 lists adverse experiences which were reported in ≥5% of patients receiving Prometrium Capsules, 400 mg/day, in a multicenter, randomized, double-blind, placebo-controlled clinical trial in estrogen-primed (6 weeks) postmenopausal women receiving conjugated estrogens 0.625 mg/day and cyclic (10 days per calendar month cycle) Prometrium Capsules at a dose of 400 mg/day, for three cycles.

The most common adverse experiences reported in ≥5% of patients in all Prometrium Capsules dosage groups studied in this trial (100 mg/day to 400 mg/day) were: dizziness (16%), breast pain (11%), headache (10%), abdominal pain (10%), fatigue (9%), viral infection (7%), abdominal distention (6%), musculoskeletal pain (6%), emotional lability (6%), irritability (5%), and upper respiratory tract infection (5%).

Other adverse events reported in <5% of patients taking Prometrium Capsules include:

Blood and Lymphatic System: lymphadenopathy

Cardiac Disorders: angina pectoris, palpitation

Ear and Labryinth Disorders: earache

Eye Disorders: abnormal vision

Gastrointestinal System Disorders: constipation, dry mouth, dyspepsia, gastroenteritis, hemorrhagic rectum, hiatus, hernia, vomiting

General Disorders: chest pain, fever

Administration Site Conditions: edema, edema peripheral

Infections: abscess, herpes simplex

Injury, Poisoning and Procedural Complications: accidental injury

Musculoskeletal and Connective Tissue Disorders: arthritis, leg cramps, muscle disorder, myalgia

Nervous System Disorders: hypertonia, impaired concentration, somnolence, speech disorder

Psychiatric Disorders: anxiety, confusion, insomnia, personality disorder

Renal and Urinary Disorders: urinary tract infection

Reproductive System Disorders: leukorrhea, vaginal dryness, uterine fibroid, fungal vaginitis, vaginitis

Respiratory System Disorders: nasal congestion, pneumonitis, bronchitis, pharyngitis, sinusitis

Skin and Subcutaneous Tissue Disorders: acne, verruca, wound debridement

Vascular Disorders: hypertension

The following adverse experiences have been reported with Prometrium Capsules in other U.S. clinical trials: increased sweating, asthenia, tooth disorder, anorexia, increased appetite, nervousness, and breast enlargement.

In addition to the adverse events observed in clinical trials, the following spontaneous adverse events have been reported during the marketing of Prometrium Capsules.

Cardiac Disorders: circulatory collapse, tachycardia

Congenital, Familial, and Genetic Disorders: cleft lip, cleft palate, congenital heart disease, patent ductus arteriosus, ventricular septal defect

Ear and Labyrinth Disorders: tinnitus, vertigo

Eye Disorders: blurred vision, diplopia, visual disturbance

Gastrointestinal Disorders: acute pancreatitis, dysphagia, swollen tongue

General Disorders and Administration Site Conditions: abnormal gait, difficulty walking, feeling abnormal, feeling drunk

Hepatobiliary Disorders: cholestasis, cholestatic hepatitis, jaundice, hepatitis, hepatic failure, hepatic necrosis, increased liver function tests

Immune System Disorders: anaphylactic reaction, hypersensitivity

Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased, hepatic enzyme increased, blood glucose increased, weight decreased, weight increased

Musculoskeletal Disorders: arthralgia, muscle cramp

Neoplasms Benign, Malignant, and Unspecified: endometrial carcinoma

Nervous System Disorders: convulsion depressed consciousness, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack

Pregnancy, Puerperium, and Perinatal Conditions: intra-uterine death, spontaneous abortion

Psychiatric Disorders: aggression, depersonalization, disorientation, suicidal ideation,

Reproductive System and Breast Disorders: menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst

Respiratory, Thoracic, and Mediastinal Disorders: asthma, choking, dyspnea, face edema, throat tightness

Skin and Subcutaneous Tissue Disorders: alopecia, pruritus, urticaria

Vascular Disorders: hypertension, hypotension

The following additional adverse experiences have been observed in women taking estrogen and/or progestins in general: breakthrough bleeding, spotting, change in menstrual flow, amenorrhea, changes in weight (increase or decrease), changes in the cervical squamo-columnar junction and cervical secretions, cholestatic jaundice, anaphylactoid reactions and anaphylaxis, rash (allergic) with and without pruritus, melasma or chloasma, that may persist when drug is discontinued, dysmenorrhea, increase in size of uterine leiomyomata, ovarian cancer, endometrial hyperplasia, endometrial cancer, galactorrhea, nipple discharge, increased incidence of gallbladder disease, enlargement of hepatic hemangiomas, erythema multiforme, erythema nodosum, hirsutism, hemorrhagic eruption, intolerance to contact lenses, migraine, chorea, reduced carbohydrate tolerance, aggravation of porphyria, changes in libido, hypocalcemia, angioedema, exacerbation of asthma, increased triglycerides.

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