Drug Safety Information for SYMMETREL (Amantadine hydrochloride)

Safety-related Labeling Changes for GOCOVRI (AMANTADINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for SYMMETREL* (Amantadine 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 SYMMETREL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall426
2Fatigue328
3Convulsion265
4Gait disturbance263
5Tremor253
6Depression*250
7Asthenia245
8Nausea240
9Hallucination*230
10Multiple sclerosis relapse226
11Dizziness223
12Condition aggravated221
13Drug ineffective214
14Urinary tract infection214
15Headache201
16Confusional state201
17Dyskinesia200
18Pain185
19Insomnia*181
20Dyspnoea180

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

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

Reason # of FDA Reports
1Parkinson's disease3069
2Product used for unknown indication3037
3Fatigue1195
4Parkinsonism370
5Multiple sclerosis256
6Hepatitis c220
7Dyskinesia168
8Tremor111
9Cerebral infarction100
10Influenza*94

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


Types of Adverse Events for SYMMETREL

Total Reports Filed with FDA: 29611


Number of FDA Adverse Event Reports by Patient Age for SYMMETREL

Total Reports Filed with FDA: 29611*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amantadine hydrochloride (Aman, Amantadine, Mantadix, Amantadin al, Amanta, Amantadine sulfate, Amantadine hcl, Tregor, Symadine, Amantadina, Symmetrel)

Charts are based on 29611 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 SYMMETREL Reviews and Review Summary .

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.