Tizanidine: adverse event reports filed with FDA

4,259

reports as suspect product

0% of all reports · about 195 a year

376

reports, 12 months to June 2026

192 in the 12 months before

69.8%

marked serious by the reporter

75.5% across the class

26.2%

record death among outcomes, as reported

1,117 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Tizanidine reports recording the termmedian drug in central alpha-2 adrenergic agonist

1. Completed suicidedeath by suicide14.6%621
2. Toxicity to various agentspoisoning or toxic effect of one or more substances9.6%407
3. Drug ineffectivethe medicine did not work as expected8.5%363
4. Somnolencedrowsiness8.5%362
5. Hypotensionlow blood pressure5.8%245
6. Drug interactionan interaction between medicines5.7%244
7. Falla fall5.6%239
8. Fatiguetiredness5.4%232
9. Dizzinesslight-headedness or unsteadiness5.1%216
10. Coma4.2%178
11. Gait disturbancedifficulty walking4.1%176
12. Nauseafeeling sick4.1%173
13. Pneumonia aspirationlung infection from breathing in material3.9%164
14. Gastrooesophageal reflux diseaseacid reflux3.8%162
15. Drug hypersensitivityan allergic-type reaction to a medicine3.5%150
16. Painpain, site not specified3.5%149
17. Suspected suicide3.2%138
18. Headachehead pain3.2%136
19. Astheniaweakness or lack of energy3.2%135
20. Muscle spasmsmuscle cramps3.1%134
21. Cardio-respiratory arrestthe heart and breathing stopped3%127
22. Therapy cessation2.9%123
23. Condition aggravatedthe condition being treated got worse2.8%121
24. Deaththe patient died; cause not stated by this term2.8%118
25. Off label useused for a purpose or in a way not on the label2.8%118
26. Urinary tract infectionbladder or urinary infection2.7%117
27. Multiple sclerosis relapsea flare of multiple sclerosis2.7%115
28. Vomitingbeing sick2.7%114
29. Insomniadifficulty sleeping2.6%109
30. Overdosea dose above the recommended amount2.5%106

Top 30 of 796 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 13 drugs in the central alpha-2 adrenergic agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 31,745 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 83.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,259 reports.

Drugs most often listed in the same reports

Other products listed in reports where Tizanidine is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the central alpha-2 adrenergic agonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Tizanidine as a suspect or interacting product; reports listing it only as a concomitant medication (20,656) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.