Drug Safety Information for CRINONE (Progesterone)

Adverse Drug Reactions for CRINONE* (Progesterone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with CRINONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Breast cancer453
2Nausea334
3Headache*305
4Drug ineffective260
5Fatigue*255
6Breast cancer female230
7Dizziness*227
8Anxiety*223
9Pain219
10Insomnia*203
11Depression*174
12Diarrhoea163
13Dyspnoea163
14Abortion spontaneous159
15Arthralgia145
16Vomiting131
17Weight increased*120
18Abdominal pain118
19Feeling abnormal117
20Asthenia116

* This side effect also appears in "Top 10 Side Effects of CRINONE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking CRINONE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication2254
2Hormone replacement therapy*1780
3Menopause*609
4Menopausal symptoms*375
5In vitro fertilisation302
6Hot flush*246
7Infertility162
8Pregnancy146
9Prophylaxis134
10Menstruation irregular*128

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for CRINONE

Total Reports Filed with FDA: 21938


Number of FDA Adverse Event Reports by Patient Age for CRINONE

Total Reports Filed with FDA: 21938*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Progesterone (Cyclogest, Prochieve, Progest, Natural progesterone, Endometrin, Progestasert, Crinone, Prometrium, Progesterone)

Charts are based on 21938 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and CRINONE Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

Visit   DrugInformer.com more on CRINONE's side effects.