Endometrin Side Effects

Generic Name: progesterone,prochieve,progestins

Please note - some side effects for Endometrin 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 Endometrin - for the Consumer

Endometrin Insert

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 Endometrin Insert:

Bloating; breast tenderness; constipation; cramping; drowsiness; fluid retention; headache; nausea; stomach pain; tiredness; vaginal burning or irritation; vomiting.

Severe allergic reactions (eg, rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf or leg pain, swelling, or tenderness; change in emotions, mood, or behavior; chest pain; coughing up blood; fainting; one-sided weakness; pain in the groin; partial or complete loss of vision; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; unusual vaginal itching, discharge, or odor; visual or speech disturbances; weakness or numbness in an arm or leg; yellowing of the skin or eyes.

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.

Endometrin Side Effects - for the Professional

Endometrin

Clinical Studies Experience

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 safety data reflect exposure to Endometrin in 808 infertile women (74.9% White, 10.3% Hispanic, 5.4% Black, 5% Asian, and 4.6% Other) in a single Assisted Reproductive Technology 10 week clinical study conducted in the U.S. Endometrin was studied at doses of 100 mg twice daily and 100 mg three times daily. The adverse reactions that occurred at a rate greater than or equal to 2% in either Endometrin group are summarized in Table 1.

Other less common reported adverse reactions included vaginal irritation, itching, burning, discomfort, urticaria, and peripheral edema.

Expected Adverse Reaction Profile Seen with Progesterone

Endometrin is also expected to have adverse reactions similar to other drugs containing progesterone that may include breast tenderness, bloating, mood swings, irritability, and drowsiness.

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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