tramadol hydrochloride tablet film coated

1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1 )] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia or are not expected to provide adequate analgesia. Tramadol hydrochloride tablets are an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate ( 1 ). Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses ( 5.1 ), reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: • Have not been tolerated or are not expected to be tolerated. • Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

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FDA Reported Adverse Reactions
[1] fatigue    [2] drug ineffective    [3] nausea    [4] pain    [5] headache    [6] off label use    [7] dyspnoea    [8] diarrhoea    [9] vomiting    [10] arthralgia