Drug Safety Information for CABERGOLINE (Cabergoline)

FDA Safety-related Labeling Changes for DOSTINEX (CABERGOLINE) Brand name discontinued; available as generic: Safety Information Link

Adverse Drug Reactions for CABERGOLINE* (Cabergoline)

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 CABERGOLINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Mitral valve incompetence142
2Headache*133
3Aortic valve incompetence133
4Drug ineffective129
5Dyspnoea127
6Nausea*120
7Dizziness*115
8Condition aggravated98
9Fatigue*96
10Cardiac valve disease88
11Blood prolactin increased87
12Hallucination85
13Pleural effusion80
14Malaise79
15Drug interaction77
16Oedema peripheral74
17Fall73
18Depression*69
19Tricuspid valve incompetence68
20Vomiting65

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

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

Reason # of FDA Reports
1Parkinson's disease2862
2Prolactinoma*882
3Hyperprolactinaemia*809
4Pituitary tumour benign*578
5Product used for unknown indication577
6Restless legs syndrome347
7Pituitary tumour*232
8Blood prolactin increased187
9Lactation inhibition therapy183
10Ill-defined disorder178

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


Types of Adverse Events for CABERGOLINE

Total Reports Filed with FDA: 11897


Number of FDA Adverse Event Reports by Patient Age for CABERGOLINE

Total Reports Filed with FDA: 11897*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Cabergoline (Cabaser, Cabaseril, Dostinex, Cabergoline)

Charts are based on 11897 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 CABERGOLINE 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.