Drug Safety Information for MIRAPEX (Pramipexole dihydrochloride)

Safety-related Labeling Changes for MIRAPEX (PRAMIPEXOLE DIHYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for MIRAPEX ER (PRAMIPEXOLE DIHYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for MIRAPEX* (Pramipexole dihydrochloride)

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 MIRAPEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pathological gambling1109
2Drug ineffective805
3Obsessive-compulsive disorder693
4Pain689
5Nausea*656
6Depression636
7Emotional distress526
8Fatigue500
9Dizziness495
10Anxiety486
11Insomnia*470
12Fall464
13Somnolence*449
14Dyspnoea442
15Headache388
16Condition aggravated374
17Tremor371
18Asthenia361
19Weight increased*351
20Restless legs syndrome340

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

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

Reason # of FDA Reports
1Restless legs syndrome*11448
2Parkinson's disease*8343
3Product used for unknown indication3856
4Tremor259
5Fibromyalgia*224
6Muscle spasms222
7Parkinsonism216
8Depression*114
9Periodic limb movement disorder*102
10Multiple sclerosis82

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


Types of Adverse Events for MIRAPEX

Total Reports Filed with FDA: 50328


Number of FDA Adverse Event Reports by Patient Age for MIRAPEX

Total Reports Filed with FDA: 50328*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pramipexole dihydrochloride (Pramipexole, Mirapex er, Mirapex)

Charts are based on 50328 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 MIRAPEX 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.