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These highlights do not include all the information needed to use children who developed life-threatening respiratory depression or died after taking tramadol for pain relief 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 IV Initial U.S. Approval: 1995
Medication labelWhy this: Advisory · dailymed-prescription
Tramadol -the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limit ations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, 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. and misuse with opioids, even at recommended doses, 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 Tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. tablets are not indicated as an as
- generic_name
- tramadol hydrochloride
- product_names
- TRAMADOL HYDROCHLORIDE
- ndc
- 45865-876, 47335-859, 45865-876-30
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en