ARXO-2026-0319 · Reported
oxycodone hydrochloride: Highlights, Drug Interactions has no instruction for a patient the label covers
Highlights, Drug Interactions reads “Can potentiate the effects of morphine”. Example: The MAOI line in Highlights of an oxycodone label names morphine; section 7 does not. The same text is in 63 labels from 28 labelers in the DailyMed release of 29 October 2026.
Consequence
Potential effect on a prescribing decision: low; careful reading of the whole label usually resolves it. Arxo does not say which instruction is correct and gives no dose.
- Jurisdiction
- United States — federal
- Act
- oxycodone hydrochloride prescribing information (SPL set ID 5a8157d3-ba20-4abf-b0d4-6ad141b31d63)
- Place
- Highlights, Drug Interactions
- Record
- Discrepancy
- Class
- Text of the act
- Where it arose
- The text of the act
- Arxo's conclusion
- Confirmed
- Official text
- Unchanged at last check
- Last checked
- 2026-10-31
Evidence
Contradiction within the text. Quotations are verbatim from the official material; translations are ours and marked.
Can potentiate the effects of morphine
How to check it without Arxo's tools
- Open Prescribing information, SpecGx LLC, SPL set ID 5a8157d3-ba20-4abf-b0d4-6ad141b31d63, version 30 (DailyMed) and find Highlights, Drug Interactions. Compare the text with the quotation above. A copy is kept in this register: 953077444e91f343-5a8157d3-ba20-4abf-b0d4-6ad141b31d63-v30.xml (SHA-256
953077444e91f3435c9228e2d3a0512ac7f0f0631cd4356acf9286cfb7f0b22b, copy of the official file). - The finding holds if the quoted passages read as shown and the comparison gives the result stated at the top of this page. If it does not, write to us with the record ID.
How this finding was made
AI agents read the labels, compared their parts and, where marked, ran the example patient through executable rules; an AI agent then read each place in full, with tables and footnotes, and confirmed it. No clinician has assessed these places. A person at Arxo approved publication (2026-10-31).
Responsible institutions
- SpecGx LLC — holder of the labeling
- Protega Pharmaceuticals Inc. — holder of the labeling
- U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling
Reported to
| Date | Institution | Channel | Reference |
|---|---|---|---|
| 2026-10-31 | SpecGx LLC | ||
| 2026-10-31 | Protega Pharmaceuticals Inc. | ||
| 2026-10-31 | U.S. Food and Drug Administration, Center for Drug Evaluation and Research |
Responses
No response recorded.
History
- 2026-10-31Confirmed by Arxo
- 2026-10-31Reported to SpecGx LLC (e-mail)
- 2026-10-31Reported to Protega Pharmaceuticals Inc. (e-mail)
- 2026-10-31Reported to U.S. Food and Drug Administration, Center for Drug Evaluation and Research (e-mail)
Cite this record
Arxo Law, Arxo Findings Register, ARXO-2026-0319, https://arxo.io/findings/ARXO-2026-0319/ (status as of 2026-10-31). Data: ARXO-2026-0319.json.