Drug Safety Information for REPRONEX (Menotropins (fsh;lh))

Adverse Drug Reactions for REPRONEX* (Menotropins (fsh;lh))

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 REPRONEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Ovarian hyperstimulation syndrome176
2Abortion spontaneous48
3Ascites48
4Dyspnoea36
5Pregnancy30
6Ectopic pregnancy28
7Headache28
8Abdominal pain26
9Maternal exposure before pregnancy26
10Nausea26
11Abdominal distension*25
12Drug ineffective22
13Caesarean section19
14Premature baby15
15Multiple pregnancy15
16Twin pregnancy14
17Maternal drugs affecting foetus14
18Malaise14
19Pleural effusion14
20Pyrexia13

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

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

Reason # of FDA Reports
1In vitro fertilisation497
2Infertility312
3Ovulation induction247
4Product used for unknown indication194
5Infertility female97
6Assisted fertilisation80
7Ovarian disorder48
8Ovarian hyperstimulation syndrome27
9Artificial insemination by partner26
10Ovulation disorder7

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


Types of Adverse Events for REPRONEX

Total Reports Filed with FDA: 2198


Number of FDA Adverse Event Reports by Patient Age for REPRONEX

Total Reports Filed with FDA: 2198*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Menotropins (fsh;lh) (Humegon, Menopur, Menotropins, Repronex, Pergonal)

Charts are based on 2198 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 REPRONEX Reviews and Review Summary .

Historical 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.