Drug Safety Information for AUBAGIO (Teriflunomide)

FDA Safety-related Labeling Changes for AUBAGIO (TERIFLUNOMIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AUBAGIO* (Teriflunomide)

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 AUBAGIO
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Alopecia	1350
2	Diarrhoea	1182
3	Drug dose omission	850
4	Fatigue	825
5	Nausea	808
6	Multiple sclerosis relapse	744
7	Paraesthesia	645
8	Hypoaesthesia	638
9	Headache	608
10	Fall	519
11	Gait disturbance	512
12	Pain	497
13	Asthenia	406
14	Dizziness	377
15	Pain in extremity	371
16	Malaise	328
17	Weight decreased	322
18	Muscular weakness	319
19	Memory impairment	314
20	Feeling abnormal	287

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

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

	Reason	# of FDA Reports
1	Multiple sclerosis	30226
2	Relapsing-remitting multiple sclerosis	1305
3	Product used for unknown indication	962
4	Multiple sclerosis relapse	243
5	Secondary progressive multiple sclerosis	37
6	Progressive multiple sclerosis	17
7	Progressive relapsing multiple sclerosis	15
8	Crohn's disease	5
9	Encephalitis	4
10	Gait disturbance	3

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

Types of Adverse Events for AUBAGIO

Total Reports Filed with FDA: 34701

Number of FDA Adverse Event Reports by Patient Age for AUBAGIO

Total Reports Filed with FDA: 34701*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Teriflunomide (Aubagio)

Charts are based on 34701 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.