ARXO-2026-0320 · Reported

acamprosate calcium: 2.1 and 4.2 give different instructions for one patient

2.1 reads “creatinine clearance of 30 to 50 mL/min”. 4.2 reads “creatinine clearance of ≤30 mL/min”. Example: At creatinine clearance exactly 30 mL/min the label gives a reduced dose (2.1, 5.1, 12.3) and a contraindication (4.2, 8.6, Highlights). The same text is in 8 labels from 8 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: acamprosate calcium prescribing information (SPL set ID 0c729939-d2d2-4e61-acbc-4f1646dc38c1)
Place: 2.1 and 4.2
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.

creatinine clearance of 30 to 50 mL/min

Official publication · Prescribing information, Zydus Lifesciences Limited, SPL set ID 0c729939-d2d2-4e61-acbc-4f1646dc38c1, version 4 (DailyMed) · 2.1 · version 4 · retrieved 2026-10-29 · SHA-256 a86a100e30e8883ef296447f86b6bbc017f6bc530beaf59fc5334070ec143dbc · copy

creatinine clearance of ≤30 mL/min

Official publication · Prescribing information, Zydus Lifesciences Limited, SPL set ID 0c729939-d2d2-4e61-acbc-4f1646dc38c1, version 4 (DailyMed) · 4.2 · version 4 · retrieved 2026-10-29 · SHA-256 a86a100e30e8883ef296447f86b6bbc017f6bc530beaf59fc5334070ec143dbc · copy

How to check it without Arxo's tools

Open Prescribing information, Zydus Lifesciences Limited, SPL set ID 0c729939-d2d2-4e61-acbc-4f1646dc38c1, version 4 (DailyMed) and find 2.1; 4.2. Compare the text with the quotation above. A copy is kept in this register: a86a100e30e8883e-0c729939-d2d2-4e61-acbc-4f1646dc38c1-v4.xml (SHA-256 a86a100e30e8883ef296447f86b6bbc017f6bc530beaf59fc5334070ec143dbc, 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

Zydus Pharmaceuticals — holder of the labeling
Glenmark Pharmaceuticals Inc., USA — holder of the labeling
Somerset Therapeutics, LLC — 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
2026-10-31	Zydus Pharmaceuticals	e-mail
2026-10-31	Glenmark Pharmaceuticals Inc., USA	e-mail
2026-10-31	Somerset Therapeutics, LLC	e-mail
2026-10-31	U.S. Food and Drug Administration, Center for Drug Evaluation and Research	e-mail

Date

Institution

Channel

Reference

2026-10-31

Zydus Pharmaceuticals

e-mail

2026-10-31

Glenmark Pharmaceuticals Inc., USA

e-mail

2026-10-31

Somerset Therapeutics, LLC

e-mail

2026-10-31

U.S. Food and Drug Administration, Center for Drug Evaluation and Research

e-mail

Responses

No response recorded.

History

2026-10-31Confirmed by Arxo
2026-10-31Reported to Zydus Pharmaceuticals (e-mail)
2026-10-31Reported to Glenmark Pharmaceuticals Inc., USA (e-mail)
2026-10-31Reported to Somerset Therapeutics, LLC (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-2026-0320, https://arxo.io/findings/ARXO-2026-0320/ (status as of 2026-10-31). Data: ARXO-2026-0320.json.