Prochieve

Last updated on RxList: 5/2/2016
Prochieve Side Effects Center

Last reviewed on RxList 04/21/2017

Prochieve (progesterone gel) is a bioadhesive vaginal gel containing micronized progesterone, a female hormone, 8% indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology ("ART") treatment for infertile women with progesterone deficiency and Prochieve 4% is indicated for the treatment of secondary amenorrhea. Prochieve 8% is indicated for use in women who have failed to respond to treatment with Prochieve 4%. Common side effects of Prochieve include:

Prochieve 8% is administered vaginally at a dose of 90 mg once daily in women who require progesterone supplementation. Prochieve 8% is administered vaginally at a dose of 90 mg twice daily in women with partial or complete ovarian failure who require progesterone replacement. Prochieve 4% is administered vaginally every other day up to a total of six doses to treat secondary amenorrhea. For women who fail to respond, a trial of Prochieve 8% every other day up to a total of six doses may be instituted. Prochieve may interact with other drugs. Tell your doctor all medications and supplements you use. Prochieve 8% has been used to support embryo implantation and maintain pregnancies through its use as part of ART treatment regimen. Consult your doctor if you plan to become pregnant or become pregnant while taking Prochieve. Prochieve passes into breast milk. Its effects on a nursing infant are unknown. Consult your doctor before breastfeeding.

Our Prochieve (progesterone gel) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Prochieve Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • unusual vaginal bleeding;
  • pain or burning when you urinate;
  • symptoms of depression (sleep problems, weakness, mood changes);
  • a breast lump;
  • sudden vision problems, severe headache or pain behind your eyes;
  • heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with speech or balance;
  • signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • dizziness, confusion, drowsiness, tiredness;
  • headache, mood changes, feeling nervous or irritable;
  • stomach pain, nausea, diarrhea, constipation;
  • bloating, swelling in your hands or feet;
  • breast pain, swelling, or tenderness;
  • cramps, pelvic pain; or
  • vaginal itching, burning, or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prochieve (Progesterone Gel For Vaginal Use Only)

QUESTION

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Prochieve Professional Information

SIDE EFFECTS

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 Advers e 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 Advers e 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%)

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

Read the entire FDA prescribing information for Prochieve (Progesterone Gel For Vaginal Use Only)

© Prochieve Patient Information is supplied by Cerner Multum, Inc. and Prochieve Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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