Drug Safety Information for ELDEPRYL (Selegiline hydrochloride)

Safety-related Labeling Changes for ZELAPAR (SELEGILINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ELDEPRYL* (Selegiline hydrochloride)

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 ELDEPRYL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pathological gambling81
3Parkinson's disease68
6Drug interaction62
8Condition aggravated59
12Hallucination, visual51
14Drug ineffective48
18Obsessive-compulsive disorder44
19Gait disturbance43
20Oedema peripheral41

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

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

Reason # of FDA Reports
1Parkinson's disease*1649
2Product used for unknown indication236
5Hiv infection41
6Ill-defined disorder29
8Multiple system atrophy16
10Drug effect decreased11

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

Types of Adverse Events for ELDEPRYL

Total Reports Filed with FDA: 5939

Number of FDA Adverse Event Reports by Patient Age for ELDEPRYL

Total Reports Filed with FDA: 5939*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Selegiline hydrochloride (Selegiline, Zelapar, Eldepryl)

Charts are based on 5939 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 ELDEPRYL 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.

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