ARXO-2026-0325 · Reported
emtricitabine: 2.4 and 2.5 give different instructions for one patient
2.4 reads “0–3 months of age”. 2.5 reads “3 months through 17 years of age”. Example: An infant aged exactly 3 months matches both sections, with doses of 3 mg per kg and 6 mg per kg. The same text is in 4 labels from 4 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
- emtricitabine prescribing information (SPL set ID d6599395-3944-44f9-97f2-e0424c6b6a1f)
- Place
- 2.4 and 2.5
- 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.
0–3 months of age3 months through 17 years of age
How to check it without Arxo's tools
- Open Prescribing information, Gilead Sciences, Inc., SPL set ID d6599395-3944-44f9-97f2-e0424c6b6a1f, version 14 (DailyMed) and find 2.4; 2.5. Compare the text with the quotation above. A copy is kept in this register: 1f6311ec6a1b54b4-d6599395-3944-44f9-97f2-e0424c6b6a1f-v14.xml (SHA-256
1f6311ec6a1b54b44568a95816c0efe60eaa20f353a07e30b2221204b0dd7796, 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
- Gilead Sciences, 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 | Gilead Sciences, 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 Gilead Sciences, 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-2026-0325, https://arxo.io/findings/ARXO-2026-0325/ (status as of 2026-10-31). Data: ARXO-2026-0325.json.