Recommended Topic Related To:

Crinone

"High cholesterol levels may impair fertility in couples trying to achieve a pregnancy, according to a study by researchers at the National Institutes of Health, the University at Buffalo (New York), and Emory University in Atlanta.

Coup"...

Crinone

Crinone Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

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 termed progesterone gel. Progesterone and progestins have been used to prevent miscarriage in women with a history of recurrent spontaneous pregnancy losses. No adequate evidence is available to show that they are effective for this purpose. Common side effects include: bloating, pain, dizziness, headache, nausea, vaginal discharge, and vaginal itching.

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. No drug interactions have been assessed with Crinone. The drug has been used to support embryo implantation and to maintain pregnancy. Serious side effects are related to thrombotic disorders. The physician should be alert to the earliest manifestations of thrombotic disorders such as cerebrovascular disorders and pulmonary embolism. Should any of these occur or be suspected, the drug should be discontinued immediately. Detectable amounts of progestins have been identified in the milk of mothers receiving them. The effect of this on the nursing infant has not been determined. Safety and effectiveness of Crinone in pediatric patients has not been established.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Crinone in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • 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;
  • nausea, stomach pain, low fever, 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).

Less serious side effects may include:

  • mild nausea, vomiting, bloating, stomach cramps;
  • diarrhea, constipation, bloating;
  • dizziness, drowsiness, tired feeling;
  • pain in your vaginal or rectal area;
  • pain during intercourse;
  • loss of interest in sex;
  • breast pain, swelling, or tenderness;
  • joint or muscle pain;
  • increased night-time urination; or
  • vaginal itching, burning, or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Crinone (Progesterone Gel) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Crinone Overview - Patient Information: Side Effects

SIDE EFFECTS: Bloating, cramps, stomach pain, constipation, diarrhea, nausea, breast swelling/pain, pain around the vaginal area, drowsiness, tiredness, decreased interest in sex, joint pain, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

You may develop a vaginal discharge containing little white balls of gel from using this medication. This is normal and harmless. However, if you develop any unusual vaginal discharge, itching, or odor, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, nervousness, mood swings), signs of water weight gain (e.g., swollen feet/ankles), increased urination at night, abnormal vaginal bleeding, breast lumps, yellowing of the eyes or skin.

Seek immediate medical attention if any of these rare but very serious side effects occur: pain/redness/swelling of arms or legs, trouble breathing, chest pain, weakness on one side of the body, slurred speech, vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Crinone (Progesterone Gel)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Crinone FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 8%
  Arthralgia 8%
Psychiatric
  Depression 11%
  Libido Decreased 10%
  Nervousness 16%
  Somnolence 27%
Reproductive, Female
  Breast Enlargement 40%
Dyspareunia
  Urinary System 6%
  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) »

A A A

Crinone - User Reviews

Crinone User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Crinone sorted by most helpful. Patient Discussions FAQs

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.


Trying to Conceive

Get tips and advances in treatment.