Tonix Pharmaceuticals’ TONMYA Receives Updated Safety Details, Highlights Potential Risks
September 17, 2025 – Tonix Pharmaceuticals holding Corp. (TNXP) has released updated safety information regarding TONMYA (cyclobenzaprine HCl), its drug for fibromyalgia. The information,detailed in recent prescribing information,outlines potential adverse reactions,drug interactions,and specific considerations for use in various patient populations.
The most frequently reported adverse reactions in clinical trials with TONMYA (occurring in at least 2% of patients at a higher rate than with placebo) include oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.
The company strongly cautions against concurrent use of TONMYA with MAO inhibitors due to the risk of life-threatening interactions. It also notes potential for serotonin syndrome when combined with other serotonergic drugs, enhanced CNS depressant effects when used with alcohol or other CNS depressants, and an increased seizure risk when taken with tramadol. Furthermore, TONMYA may block the antihypertensive action of guanethidine or similar medications.
Specific populations require careful consideration. Animal data suggest TONMYA may cause fetal harm, and the company advises women to avoid use two weeks prior to conception and throughout the first trimester of pregnancy.Pregnant women are encouraged to report their pregnancies to Tonix Medicines, Inc. at 1-888-869-7633 (1-888-TNXPMED).Limited data exists regarding TONMYA’s presence in human milk, and its effects on breastfeeding infants are unkown, requiring a careful benefit-risk assessment. TONMYA’s safety and effectiveness have not been established in pediatric patients.
For patients with mild hepatic impairment (Child Pugh A), a reduced dosage of 2.8 mg once daily is recommended. TONMYA is not recommended for those with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment, as cyclobenzaprine exposure was increased in patients with HI, potentially raising the risk of adverse reactions.
Tonix Pharmaceuticals urges healthcare professionals and patients to consult the full Prescribing Information for complete safety details. Suspected adverse reactions should be reported to Tonix Medicines, Inc. at 1-888-869-7633 or to the FDA at 1-800-FDA-1088 or via www.fda.gov/medwatch.
