Crinone

Last updated on RxList: 9/29/2020
Crinone Side Effects Center

What Is Crinone?

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.

What Are Side Effects of Crinone?

Common side effects of Crinone include:

  • bloating,
  • stomach pain,
  • dizziness,
  • drowsiness,
  • tired feeling,
  • headache,
  • nausea,
  • vomiting,
  • stomach cramps,
  • diarrhea,
  • constipation,
  • pain in your 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.

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).

Dosage for Crinone

Crinone is available in strengths of 4% gel (45 mg) and 8% gel (45 mg) in single use vaginal applicators. Crinone 4% is indicated for the treatment of secondary amenorrhea is dosed every other day for 6 total doses. Crinone 8% is indicated for use in women who have failed to respond to treatment with Crinone 4% but is dosed for infertility treatment at twice daily for 10 – 12 weeks.

What Drugs, Substances, or Supplements Interact with Crinone?

Crinone may interact with other drugs. Tell your doctor all medications and supplements you use.

Crinone During Pregnancy and Breastfeeding

Tell your doctor if you become pregnant during treatment with Crinone. Do not use Crinone without your doctor's consent if you are pregnant, unless you are using the medication as part of your fertility treatment. If you are not being treated for infertility, talk to your doctor about using birth control while you are using Crinone. Crinone can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Crinone (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.

SLIDESHOW

Fertility Options: Types, Treatments, and Costs See Slideshow
Crinone Consumer Information

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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 Crinone (Progesterone Gel)

QUESTION

Men and women are equally likely to have fertility problems. See Answer
Crinone Professional Information

SIDE EFFECTS

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
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 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 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 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 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
  Pruritus Genital 1 (2%) 4 (6%)

Read the entire FDA prescribing information for Crinone (Progesterone Gel)

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

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