What is tapentadol used for?

Indications and Usage, quoted from the label by Novadoz Pharmaceuticals LLC (ANDA220865). Cross-references to other label sections are left out.

Tapentadol tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dose or duration, and persist over the course of therapy, reserve opioid analgesics, including tapentadol tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA tablets. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Source: DailyMed label, set id d4c5938a-68f0-46d2-9bad-8988d5724b09, version 1, effective September 3, 2026. NDC 72205-369, one of 9 listings for this product.

Indications and Usage, quoted from the label by ANI Pharmaceuticals, Inc. (ANDA219119). Cross-references to other label sections are left out.

Tapentadol hydrochloride oral solution is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate in adults.

Limitations of Use

Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy,, reserve opioid analgesics, including tapentadol hydrochloride oral solution for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Pediatric use information is approved for Collegium Pharmaceutical, Inc.’s NUCYNTA oral solution. However, due to Collegium Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Source: DailyMed label, set id e0ecb809-6a55-4afe-b981-b8f174e5c344, version 2, effective July 27, 2026. NDC 70954-801, one of 1 listing for this product.