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