Prochieve Side Effects

Brand Names: Crinone, Endometrin, Prometrium

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

Prochieve Gel

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 Prochieve Gel:

Breast enlargement; breast pain; changes in sex drive; constipation; cramps; depression; diarrhea; difficult or painful sexual intercourse; drowsiness; fatigue; fluid retention/bloating; headache; increased appetite; joint pain; nausea; nervousness; pain around vaginal area; sleep disorder; urination at night; vomiting.

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

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; calf/leg pain or tenderness; change in emotions, mood, or behavior; chest pain; coughing blood; dizziness; fainting; inflammation of the eye; numbness of arm or leg; one-sided weakness; pain in the groin; partial or complete loss of vision; seizure; stomach pain, swelling, or tenderness; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands, ankles, or feet; tremor; unusual vaginal discharge or odor; vaginal itching; 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.

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Prochieve Side Effects - for the Professional

Prochieve

Assisted Reproductive Technology

In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Prochieve® 8% twice daily, treatment-emergent adverse events occurring in 5% or more of the women are shown in Table 3.

TABLE 3 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Prochieve® 8% Twice Daily Study COL1620-007US (n=61)

Body as a Whole
Bloating	7%
Cramps NOS	15%
Pain	8%
Central and Peripheral Nervous System
Dizziness	5%
Headache	13%
Gastro-Intestinal System
Nausea	7%
Reproductive, Female
Breast Pain	13%
Moniliasis Genital	5%
Vaginal Discharge	7%
Skin and Appendages
Pruritus Genital	5%

In a second clinical study of 139 women using Prochieve® 8% once daily for luteal phase support while undergoing an in vitro fertilization procedure, treatment-emergent adverse events reported in ≥5% of the women are shown in Table 4.

TABLE 4 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Prochieve® 8% Once Daily Study COL1620-F01 (n=139)

Body as a Whole
Abdominal Pain	12%
Perineal Pain Female	17%
Central and Peripheral Nervous System
Headache	17%
Gastro-Intestinal System
Constipation	27%
Diarrhea	8%
Nausea	22%
Vomiting	5%
Musculo-Skeletal System
Arthralgia	8%
Psychiatric
Depression	11%
Libido Decreased	10%
Nervousness	16%
Somnolence	27%
Reproductive, Female
Breast Enlargement	40%
Dyspareunia	6%
Urinary System
Nocturia	13%

Secondary Amenorrhea

In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Prochieve® 4% or 8% every other day for six doses. Treatment emergent adverse events during estrogen and Prochieve® treatment that occurred in 5% or more of women are shown in Table 5.

TABLE 5 Treatment-Emergent Adverse Events in ≥5% of Women Receiving Estrogen Treatment and Prochieve® Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US

	Estrogen + Prochieve® 4% n=62	Estrogen + Prochieve® 8% n=65
Body as a Whole
Abdominal Pain	3 (5%)	6 (9%)
Appetite Increased	3 (5%)	5 (8%)
Bloating	8 (13%)	8 (12%)
Cramps NOS	12 (19%)	17 (26%)
Fatigue	13 (21%)	14 (22%)
Central and Peripheral Nervous System
Headache	12 (19%)	10 (15%)
Gastro-Intestinal System
Nausea	5 (8%)	4 (6%)
Musculo-Skeletal System
Back Pain	5 (8%)	2 (3%)
Myalgia	5.(8%)	0 (0%)
Psychiatric
Depression	12 (19%)	10 (15%)
Emotional Lability	14 (23%)	14 (22%)
Sleep Disorder	11 (18%)	12 (18%)
Reproductive, Female
Vaginal Discharge	7 (11%)	2 (3%)
Resistance Mechanism
Upper Respiratory Tract Infection	3 (5%)	5 (8%)
Skin and Appendages
Pruitis genital	1 (2%)	4 (6%)

Additional adverse events reported in women at a frequency <5% in Prochieve® ART and secondary amenorrhea studies and not listed in the tables above include:

Autonomic Nervous System–mouth dry, sweating increased

Body as a Whole–abnormal crying, allergic reaction, allergy, appetite decreased, asthenia, edema, face edema, fever, hot flushes, influenza-like symptoms, water retention, xerophthalmia

Cardiovascular, General–syncope

Central and Peripheral Nervous System–migraine, tremor

Gastro-Intestinal–dyspepsia, eructation, flatulence, gastritis, toothache

Metabolic and Nutritional–thirst

Musculo-Skeletal System–cramps legs, leg pain, skeletal pain

Neoplasm–benign cyst

Platelet, Bleeding & Clotting–purpura

Psychiatric–aggressive reactions, forgetfulness, insomnia

Red Blood Cell–anemia

Reproductive, Female–dysmenorrhea, premenstrual tension, vaginal dryness

Resistance Mechanism–infection, pharyngitis, sinusitis, urinary tract infection

Respiratory System–asthma, dyspnea, hyperventilation, rhinitis

Skin and Appendages–acne, pruritis, rash, seborrhea, skin discoloration, skin disorder, urticaria

Urinary System–cystitis, dysuria, micturition frequency

Vision Disorders–conjunctivitis

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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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