Arxo Findings Register · Arxo Law

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 TID
Official publication · Prescribing information, Viatris Specialty LLC, SPL set ID d4734e7d-5079-455e-8ff5-8f4539c998a9, version 18 (DailyMed) · 2.5, Table 2 · version 18 · retrieved 2026-10-29 · SHA-256 90e9473ed376ef5f6aac38e36ab607ff5af21f215bfb8600917a3d35e54e63eb · copy
15-30 25-50 75 100-150 150 QD or BID
Official publication · Prescribing information, Viatris Specialty LLC, SPL set ID d4734e7d-5079-455e-8ff5-8f4539c998a9, version 18 (DailyMed) · 2.5, Table 2 · version 18 · retrieved 2026-10-29 · SHA-256 90e9473ed376ef5f6aac38e36ab607ff5af21f215bfb8600917a3d35e54e63eb · copy

How to check it without Arxo's tools

  1. 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).
  2. 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

Reported to

DateInstitutionChannelReference
2026-10-31Viatrise-mail
2026-10-31U.S. Food and Drug Administration, Center for Drug Evaluation and Researche-mail

Responses

No response recorded.

History

  1. 2026-10-31Confirmed by Arxo
  2. 2026-10-31Reported to Viatris (e-mail)
  3. 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.