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Qdolo FDA Approval History

Last updated by Judith Stewart, BPharm on June 14, 2021.

FDA Approved: Yes (First approved September 1, 2020)
Brand name: Qdolo
Generic name: tramadol hydrochloride
Dosage form: Oral Solution
Company: Athena Bioscience, LLC
Treatment for: Pain

Qdolo (tramadol hydrochloride) is 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.

  • Qdolo Oral Solution (tramadol hydrochloride 5 mg/mL) should be administered with a calibrated oral syringe or other accurate oral dosing device to correctly measure the prescribed dose.
  • Qdolo contains tramadol, an opioid analgesic which is listed as a Schedule IV controlled substance because of its potential for abuse, misuse, and addiction. The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for all opioid analgesics to ensure that the benefits of these drugs outweigh the risks.
  • The Qdolo product label carries a boxed warning advising the risk of medication errors; addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; ultra-rapid metabolism of tramadol and other risk factors for life-threatening respiratory depression in children; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome p450 isoenzymes; and risks from concomitant use with benzodiazepines or other CNS depressants.
  • Common adverse reactions include dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.

Development Timeline for Qdolo

DateArticle
Sep  8, 2020Approval  FDA Approves Qdolo (tramadol hydrochloride) Oral Solution for the Management of Severe Pain

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.