Drug Safety Information for RILUTEK (Riluzole)

Safety-related Labeling Changes for RILUTEK (RILUZOLE) Rx Drug: FDA Link

Adverse Drug Reactions for RILUTEK* (Riluzole)

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 RILUTEK
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	65
2	Amyotrophic lateral sclerosis	43
3	Nausea*	35
4	Disease progression	35
5	Dyspnoea	34
6	Pyrexia	33
7	Asthenia	31
8	Pneumonia	23
9	Drug interaction	20
10	Respiratory failure	18
11	Alanine aminotransferase increased	18
12	Cough	18
13	Dysphagia	18
14	Dizziness	17
15	Aspartate aminotransferase increased	17
16	Condition aggravated	17
17	Malaise	17
18	Anxiety	16
19	Interstitial lung disease	15
20	Suicidal ideation	14

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

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

	Reason	# of FDA Reports
1	Amyotrophic lateral sclerosis	833
2	Motor neurone disease	80
3	Spinal muscular atrophy	77
4	Huntington's disease	68
5	Product used for unknown indication	61
6	Major depression	23
7	Depression	22
8	Multiple system atrophy	18
9	Mental disorder	17
10	Pyramidal tract syndrome	17

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

Types of Adverse Events for RILUTEK

Total Reports Filed with FDA: 1941

Number of FDA Adverse Event Reports by Patient Age for RILUTEK

Total Reports Filed with FDA: 1941*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Riluzole (Riluzole, Rilutek)

Charts are based on 1941 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.