Prometrium Side Effects

Generic Name: progesterone,prochieve,progestins

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.

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; fluid retention; headache; irritability; mild hair loss; muscle pain; nausea; spotting or breakthrough bleeding; stomach pain or cramping; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Prometrium:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; breast lumps or pain; bulging eyes; calf or leg pain, swelling, redness, or tenderness; coughing up blood; fainting; mental or mood changes (eg, depression, anxiety); migraine or severe headache; new or worsening memory problems; seizures; severe or persistent dizziness; severe or persistent stomach pain or tenderness; shortness of breath; swelling of the hands, ankles, or feet; symptoms of a heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; unusual sweating or weakness); symptoms of a stroke (eg, confusion; slurred speech; one-sided weakness); symptoms of liver problems (eg, dark urine, pale stools, yellowing of the skin or eyes); trouble walking; unusual vaginal discharge/itching/odor; vision problems or changes (eg, double vision; sudden, partial, or full loss of vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Prometrium Side Effects - for the Professional

Prometrium

See BOXED WARNING, 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.

In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of Prometrium Capsules on the endometrium was studied in a total of 875 postmenopausal women. Table 6 lists adverse reactions greater than or equal to 2 percent of women who received cyclic Prometrium Capsules 200 mg daily (12 days per calendar month cycle) with 0.625 mg conjugated estrogens or placebo.

TABLE 6. Adverse Reactions (≥ 2%) Reported in an 875 Patient Placebo-Controlled Trial in Postmenopausal Women Over a 3-Year Period [Percentage (%) of Patients Reporting]

	Prometrium Capsules 200 mg with Conjugated Estrogens 0.625 mg	Placebo
	(n=178)	(n=174)
Headache	31	27
Breast Tenderness	27	6
Joint Pain	20	29
Depression	19	12
Dizziness	15	9
Abdominal Bloating	12	5
Hot Flashes	11	35
Urinary Problems	11	9
Abdominal Pain	10	10
Vaginal Discharge	10	3
Nausea / Vomiting	8	7
Worry	8	4
Chest Pain	7	5
Diarrhea	7	4
Night Sweats	7	17
Breast Pain	6	2
Swelling of Hands and Feet	6	9
Vaginal Dryness	6	10
Constipation	3	2
Breast Carcinoma	2	<1
Breast Excisional Biopsy	2	<1
Cholecystectomy	2	<1

Effects on Secondary Amenorrhea

In a multicenter, randomized, double-blind, placebo-controlled clinical trial, the effects of Prometrium Capsules on secondary amenorrhea was studied in 49 estrogen-primed postmenopausal women. Table 7 lists adverse reactions greater than or equal to 5 percent of women who received Prometrium Capsules or placebo.

TABLE 7. Adverse Reactions (≥ 5%) Reported in Patients Using 400 mg/day in a Placebo-Controlled Trial in Estrogen-Primed Postmenopausal Women

Adverse Experience	Prometrium Capsules 400 mg	Placebo
	n=25	n=24
	Percentage (%) of Patients
Fatigue	8	4
Headache	16	8
Dizziness	24	4
Abdominal Distention (Bloating)	8	8
Abdominal Pain (Cramping)	20	13
Diarrhea	8	4
Nausea	8	0
Back Pain	8	8
Musculoskeletal Pain	12	4
Irritability	8	4
Breast Pain	16	8
Infection Viral	12	0
Coughing	8	0

In a multicenter, parallel-group, open label postmarketing dosing study consisting of three consecutive 28-day treatment cycles, 220 premenopausal women with secondary amenorrhea were randomized to receive daily conjugated estrogens therapy (0.625 mg conjugated estrogens) and Prometrium Capsules, 300 mg per day (n=113) or Prometrium Capsules, 400 mg per /day (n=107) for 10 days of each treatment cycle. Overall, the most frequently reported treatment-emergent adverse reactions, reported in greater than or equal to 5 percent of subjects, were nausea, fatigue, vaginal mycosis, nasopharyngitis, upper respiratory tract infection, headache, dizziness, breast tenderness, abdominal distension, acne, dysmenorrhea, mood swing, and urinary tract infection.

Postmarketing Experience:

The following additional adverse reactions have been reported with Prometrium Capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Genitourinary System: endometrial carcinoma, hypospadia, intra-uterine death, menorrhagia, menstrual disorder, metrorrhagia, ovarian cyst, spontaneous abortion.

Cardiovascular: circulatory collapse, congenital heart disease (including ventricular septal defect and patent ductus arteriosus), hypertension, hypotension, tachycardia.

Gastrointestinal: acute pancreatitis, cholestasis, cholestatic hepatitis, dysphagia, hepatic failure, hepatic necrosis, hepatitis, increased liver function tests (including alanine aminotransferase increased, aspartate aminotransferase increased, gamma-glutamyl transferase increased), jaundice, swollen tongue.

Skin: alopecia, pruritus, urticaria.

Eyes: blurred vision, diplopia, visual disturbance.

Central Nervous System: aggression, convulsion, depersonalization, depressed consciousness, disorientation, dysarthria, loss of consciousness, paresthesia, sedation, stupor, syncope (with and without hypotension), transient ischemic attack, suicidal ideation.

During initial therapy, a few women have experienced a constellation of many or all of the following symptoms: extreme dizziness and/or drowsiness, blurred vision, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, feeling drunk, and shortness of breath.

Miscellaneous: abnormal gait, anaphylactic reaction, arthralgia, blood glucose increased, choking, cleft lip, cleft palate, difficulty walking, dyspnea, face edema, feeling abnormal, feeling drunk, hypersensitivity, asthma, muscle cramp, throat tightness, tinnitus, vertigo, weight decreased, weight increased.

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Side Effects by Body System - for Healthcare Professionals

Genitourinary

Genitourinary side effects have included breast tenderness (27%), urinary problems (11%), vaginal discharge (10%), vaginal dryness (6%), breast pain (6%), breast carcinoma (2%), breast excisional biopsy (2%), breast enlargement, leukorrhea, uterine fibroid, vaginal dryness, fungal vaginitis, vaginitis, dysuria, cystitis, and urinary tract infection

Nervous system

Nervous system side effects have included headache (31%), dizziness (15%), confusion, somnolence, asthenia, increased sweating, nervousness, migraine, tremor, and speech disorder. Syncope (with and without hypotension) have been reported.

Cardiovascular

Cardiovascular side effects have included chest pain (7%), hypertension, angina pectoris, syncope, and palpitations.

Gastrointestinal

Gastrointestinal side effects have included abdominal pain (20%), bloating (8%), diarrhea (8%), nausea (8%), constipation (3%), dyspepsia, dry mouth, gastroenteritis, hemorrhagic rectum, hiatus hernia, and vomiting. The side effects reported during clinical studies evaluating the use of progesterone gel 8% have included constipation (27%), nausea (22%), and diarrhea (8%).

Musculoskeletal

Musculoskeletal side effects have included joint pain (20%), musculoskeletal pain (12%), back pain (8%), arthritis, leg cramps, hypertonia, muscle disorder, and myalgia.

Psychiatric

Psychiatric side effects have included depression (19%), anxiety, impaired concentration, insomnia, forgetfulness, and personality disorder.

Respiratory

Respiratory side effects have included cough (8%), bronchitis, nasal congestion, pharyngitis, pneumonitis, and sinusitis.

Dermatologic

Dermatologic side effects have included acne, pruritus, rash, skin discoloration, seborrhea, verruca, and wound debridement during therapy.

Additional dermatologic side effects have included case reports of familial autoimmune dermatitis.

Ocular

Ocular side effects have included abnormal vision.

Hepatic

Hepatic side effects including reversible cases of hepatitis, elevated transaminases, and cholecystectomy have been reported.

Other

Other side effects have included viral infection (12%), hot flashes (11%), fatigue (8%), irritability (8%), worry (8%), night sweats (7%), earache, tooth disorder, anorexia, increased appetite, peripheral edema, edema, accidental injury, fever, abscess, lymphadenopathy, and herpes simplex.

Immunologic

Immunologic side effects have included autoimmune dermatitis during the luteal phase of the menstrual cycle. Test results using interferon gamma release in vivo and vitro tests confirmed the diagnosis.

Local

Local side effects have included pain, irritation, and redness at the injection site.

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