Drugs
Onsolis (fentanyl buccal soluble film) Information
Onsolis contains fentanyl, an opioid pain reliever, in a small film that sticks to the inside of your cheek and eventually dissolves within 15 to 30 minutes after it is applied. Onsolis is used to manage breakthrough pain (flare-up of pain occurring in patients with otherwise stable, constant pain) in patients with cancer, 18 years of age and older, who are already using another opioid pain medicine around-the-clock and whose body is used to the medicine (opioid-tolerant).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this page.
Related Information
- FDA approves shared system REMS for TIRF products
FDA news release (12/29/2011) Questions and Answers: FDA approves a class Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines
12/29/2011Transmucosal Immediate-Release Fentanyl (TIRF) Medicines FDA Approves Opioid Pain Reliever with Required Risk Reduction Plan
7/16/2009Questions and Answers about Onsolis (fentanyl buccal soluble film)
7/16/2009
Regulatory History and Labeling from Drugs@FDA
Contact FDA
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Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
