ARXO-2026-0306 · Reported
pregabalin: 2.5, Table 2 and 2.5, Table 2 give different instructions for one patient
2.5, Table 2 reads “30-60 75 150 225 300 BID or TID”. 2.5, Table 2 reads “15-30 25-50 75 100-150 150 QD or BID”. Example: A patient with creatinine clearance exactly 30 mL/min matches both rows, with different total daily doses and regimens. The same text is in 225 labels from 60 labelers in the DailyMed release of 29 October 2026.
Consequence
Potential effect on a prescribing decision: medium. Arxo does not say which instruction is correct and gives no dose.
- Jurisdiction
- United States — federal
- Act
- pregabalin prescribing information (SPL set ID d4734e7d-5079-455e-8ff5-8f4539c998a9)
- Place
- 2.5, Table 2 and 2.5, Table 2
- 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
Reproduced by execution. Quotations are verbatim from the official material; translations are ours and marked.
30-60 75 150 225 300 BID or TID15-30 25-50 75 100-150 150 QD or BID
How to check it without Arxo's tools
- Open Prescribing information, Viatris Specialty LLC, SPL set ID d4734e7d-5079-455e-8ff5-8f4539c998a9, version 18 (DailyMed) and find 2.5, Table 2. Compare the text with the quotation above. A copy is kept in this register: 90e9473ed376ef5f-d4734e7d-5079-455e-8ff5-8f4539c998a9-v18.xml (SHA-256
90e9473ed376ef5f6aac38e36ab607ff5af21f215bfb8600917a3d35e54e63eb, 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
- Viatris — 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 | Viatris | ||
| 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 Viatris (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-2026-0306, https://arxo.io/findings/ARXO-2026-0306/ (status as of 2026-10-31). Data: ARXO-2026-0306.json.