Drug Safety Information for EMSAM (Selegiline)

FDA Safety-related Labeling Changes for EMSAM (SELEGILINE) Rx Drug: Safety Information Link

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

Adverse Drug Reactions for EMSAM* (Selegiline)

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 EMSAM
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Application site erythema	124
2	Drug ineffective	117
3	Insomnia*	105
4	Application site rash	93
5	Depression	89
6	Application site pruritus	74
7	Headache*	67
8	Anxiety	62
9	Dizziness	58
10	Application site reaction	55
11	Nausea	50
12	Drug interaction	39
13	Rash	39
14	Application site irritation	38
15	Drug effect decreased	37
16	Fatigue	37
17	Suicidal ideation	34
18	Application site urticaria	29
19	Blood pressure increased	28
20	Weight increased*	24

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

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

	Reason	# of FDA Reports
1	Depression*	1787
2	Major depression*	188
3	Bipolar disorder*	82
4	Product used for unknown indication	54
5	Parkinson's disease*	37
6	Obsessive-compulsive disorder	22
7	Bipolar i disorder*	21
8	Off label use	18
9	Influenza	15
10	Panic attack	14

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

Types of Adverse Events for EMSAM

Total Reports Filed with FDA: 3184

Number of FDA Adverse Event Reports by Patient Age for EMSAM

Total Reports Filed with FDA: 3184*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Selegiline (Deprenyl, Humex, Jumex, Emsam)

Charts are based on 3184 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.

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.