dronedarone: 7.3 and 7.3 give different instructions for one patient

7.3 reads “reduce the dose of dabigatran to 75 mg twice daily”. 7.3 reads “should be avoided”. Example: At CrCL exactly 30 mL/min, 7.3 places the patient both in the 30 to 50 band (reduce dabigatran) and in the 15 to 30 band (avoid the combination). The same text is in 2 labels from 2 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

dronedarone prescribing information (SPL set ID 7fa41601-7fb5-4155-8e50-2ae903f0d2d6)

Place

7.3 and 7.3

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.

reduce the dose of dabigatran to 75 mg twice daily

should be avoided

How to check it without Arxo's tools

1. Open Prescribing information, Sanofi-Aventis U.S. LLC, SPL set ID 7fa41601-7fb5-4155-8e50-2ae903f0d2d6, version 37 (DailyMed) and find 7.3. Compare the text with the quotation above. A copy is kept in this register: ad58e6f56c84b6c1-7fa41601-7fb5-4155-8e50-2ae903f0d2d6-v37.xml (SHA-256 ad58e6f56c84b6c17a9cd070e5d7b3aaa2acaf2bf2e3d79950625ec86e6fa54a, 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

• sanofi-aventis U.S. LLC — holder of the labeling
• U.S. Food and Drug Administration, Center for Drug Evaluation and Research — regulator of prescription drug labeling

Reported to

Responses

No response recorded.

History

1. 2026-10-31Confirmed by Arxo
2. 2026-10-31Reported to sanofi-aventis U.S. LLC (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-2026-0324, https://arxo.io/findings/ARXO-2026-0324/ (status as of 2026-10-31). Data: ARXO-2026-0324.json.