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These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE TABLETS. TRAMADOL hydrochloride extended-release tablets for oral use, C IVInitial U.S. Approval: 1995
Medication labelWhy this: Advisory · dailymed-prescription
Tramadol hydrochloride extended-release tablet is indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1)], reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Tramadol hydrochloride extended-release tablet is not indicated as an as-needed (prn) analgesic.
- generic_name
- tramadol hydrochloride
- product_names
- TRAMADOL HYDROCHLORIDE
- ndc
- 68180-697, 68180-698, 68180-699, 68180-697-06, 68180-697-01, 68180-697-02, 68180-698-06, 68180-698-01, 68180-698-02, 68180-699-06, 68180-699-01
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en