Drug Safety Information for AZILECT (Rasagiline mesylate)

FDA Safety-related Labeling Changes for AZILECT (RASAGILINE MESYLATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AZILECT* (Rasagiline mesylate)

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 AZILECT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Tremor	181
2	Drug interaction	143
3	Dyskinesia	140
4	Fall	138
5	Dizziness*	136
6	Drug ineffective*	128
7	Confusional state	122
8	Hallucination	104
9	Parkinson's disease	100
10	Somnolence	99
11	Nausea	98
12	Gait disturbance	91
13	Fatigue	84
14	Insomnia	84
15	Headache	80
16	Serotonin syndrome	77
17	Malaise	71
18	Anxiety	69
19	Weight decreased	66
20	Hyperhidrosis	65

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

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

	Reason	# of FDA Reports
1	Parkinson's disease	4429
2	Product used for unknown indication	639
3	Parkinsonism	138
4	Motor dysfunction	97
5	Tremor	67
6	On and off phenomenon	24
7	Dystonia	11
8	Motor neurone disease	9
9	Restless legs syndrome	9
10	Extrapyramidal disorder	8

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

Types of Adverse Events for AZILECT

Total Reports Filed with FDA: 8588

Number of FDA Adverse Event Reports by Patient Age for AZILECT

Total Reports Filed with FDA: 8588*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Rasagiline mesylate (Rasagiline mesylate, Azilect)

Charts are based on 8588 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.