Drug Safety Information for ZANAFLEX (Tizanidine hydrochloride)

Adverse Drug Reactions for ZANAFLEX* (Tizanidine 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 ZANAFLEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain956
2Nausea929
3Fatigue*801
4Drug ineffective*779
5Headache756
6Fall651
7Dizziness*621
8Depression619
9Asthenia569
10Vomiting566
11Dyspnoea562
12Diarrhoea506
13Back pain503
14Pain in extremity494
15Insomnia*486
16Muscle spasms477
17Anxiety*469
18Arthralgia428
19Pyrexia413
20Gait disturbance402

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

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

Reason # of FDA Reports
1Product used for unknown indication8076
2Muscle spasms*4806
3Muscle relaxant therapy2946
4Muscle spasticity1455
5Pain1080
6Back pain*690
7Fibromyalgia*661
8Multiple sclerosis*385
9Myalgia254
10Muscle disorder226

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


Types of Adverse Events for ZANAFLEX

Total Reports Filed with FDA: 68155


Number of FDA Adverse Event Reports by Patient Age for ZANAFLEX

Total Reports Filed with FDA: 68155*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Tizanidine hydrochloride (Tizanidine, Sirdalud, Zanaflex)

Charts are based on 68155 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 ZANAFLEX 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.