Does Crinone (progesterone) cause side effects?

Crinone (intravaginal progesterone gel) is used to supplement or replace progesterone in infertile women with progesterone deficiency who are receiving treatment utilizing assisted reproductive technology (ART). Crinone intravaginal gel is also used to treat secondary amenorrhea (absence of menses).

Progesterone is a female hormone and is the principal progestational hormone. Progestational hormones prepare the uterus to receive and sustain a fertilized egg. Progesterone

  • promotes the development of the mammary glands,
  • causes changes in the endometrium which lines the uterus,
  • relaxes uterine smooth muscles,
  • blocks ovulation within the ovaries, and
  • maintains pregnancy.

Common side effects of Crinone include

Serious side effects of Crinone include

There are no drug interactions listed for Crinone intravaginal gel. Crinone intravaginal gel has been used to support embryo implantation and to maintain pregnancies as part of an ART treatment regimen.

Progestins are secreted in breast milk. Consult your doctor before breastfeeding.

What are the important side effects of Crinone (progesterone)?

Crinone (progesterone) gel is a bioadhesive vaginal gel contained in single-use, one-piece polyethylene vaginal applicators. Crinone is indicated as treatment for infertile women with progesterone deficiency and women with secondary amenorrhea. Crinone is available as a generic drug.

Common side effects of Crinone include

Tell your doctor if you have serious side effects of Crinone including

  • sudden headache, numbness or weakness (especially on one side of the body):
  • shortness of breath, or problems with vision, speech, or balance;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder;
  • pain or swelling in one or both legs;
  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • swelling in your hands, ankles, or feet;
  • fever, chills, body aches, flu symptoms;
  • a breast lump; or
  • symptoms of depression (sleep problems, weakness, mood changes).

Crinone (progesterone) side effects list for healthcare professionals

Assisted Reproductive Technology

In a study of 61 women with ovarian failure undergoing a donor oocyte transfer procedure receiving Crinone 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 Crinone 8% Twice Daily Study COL1620-007US (n = 61)

Body as a Whole
Bloating7%
  Cramps NOS15%
  Pain8%
Central and Peripheral Nervous System
  Dizziness5%
  Headache13%
Gastro-Intestinal System
  Nausea7%
Reproductive, Female
  Breast Pain13%
  Moniliasis Genital5%
  Vaginal Discharge7%
Skin and Appendages
  Pruritus Genital5%

In a second clinical study of 139 women using Crinone 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 Crinone 8% Once Daily Study COL1620-F01 (n = 139)

Body as a Whole
  Abdominal Pain12%
  Perineal Pain Female17%
Central and Peripheral Nervous System
  Headache17%
Gastro-Intestinal System
  Constipation27%
  Diarrhea8%
Nausea22%
  Vomiting5%
Musculo-Skeletal System
  Arthralgia8%
Psychiatric
  Depression11%
  Libido Decreased10%
  Nervousness16%
  Somnolence27%
Reproductive, Female
  Breast Enlargement40%
  Dyspareunia6%
Urinary System
  Nocturia13%

Secondary Amenorrhea

In three studies, 127 women with secondary amenorrhea received estrogen replacement therapy and Crinone 4% or 8% every other day for six doses.

Treatment-emergent adverse events during estrogen and Crinone 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 Crinone Every Other Day Studies COL1620-004US, COL1620-005US, COL1620-009US

Estrogen + Crinone 4%
n = 62
Estrogen + Crinone 8%
n = 65
Body as a Whole
  Abdominal Pain3 (5%)6 (9%)
  Appetite Increased3 (5%)5 (8%)
  Bloating8 (13%)8 (12%)
  Cramps NOS12 (19%)17 (26%)
  Fatigue13 (21%)14 (22%)
Central and Peripheral Nervous System
  Headache12 (19%)10 (15%)
Gastro-Intestinal System
  Nausea5 (8%)4 (6%)
Musculo-Skeletal System
  Back Pain5 (8%)2 (3%)
  Myalgia5 (8%)0 (0%)
Psychiatric
  Depression12 (19%)10 (15%)
  Emotional Lability14 (23%)14 (22%)
  Sleep Disorder11 (18%)12 (18%)
Reproductive, Female
  Vaginal Discharge7 (11%)2 (3%)
Resistance Mechanism
  Upper Respiratory Tract Infection3 (5%)5 (8%)
Skin and Appendages
  Pruritus Genital1 (2%)4 (6%)

What drugs interact with Crinone (progesterone)?

No drug interactions have been assessed with Crinone.

Summary

Crinone (intravaginal progesterone gel) is used to supplement or replace progesterone in infertile women with progesterone deficiency who are receiving treatment utilizing assisted reproductive technology (ART). Crinone intravaginal gel is also used to treat secondary amenorrhea (absence of menses). Common side effects of Crinone include bloating, stomach pain or cramps, dizziness, drowsiness, tired feeling, headache, nausea, vomiting, diarrhea, constipation, pain in the vaginal or rectal area, pain during intercourse, loss of interest in sex, breast swelling or tenderness, joint or muscle pain, increased night-time urination, vaginal discharge, vaginal burning, and vaginal itching. Crinone intravaginal gel has been used to support embryo implantation and to maintain pregnancies as part of an ART treatment regimen. Progestins are secreted in breast milk.

Treatment & Diagnosis

Medications & Supplements

FDA Logo

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Medically Reviewed on 7/1/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
CONTINUE SCROLLING FOR RELATED SLIDESHOW