Japan PMDA Drug Precaution Revisions for FY2025

Detected March 12th, 2026

Summary

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has published a list of drug precaution revisions for Fiscal Year 2025, detailing updates for various nonproprietary drug names. These revisions are effective on specific dates in late 2025 and early 2026, with associated investigation summaries available.

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What changed

The Japan Pharmaceuticals and Medical Devices Agency (PMDA) has released a comprehensive list of revisions to drug precautions for Fiscal Year 2025, affecting numerous nonproprietary drug names. The updates, effective on various dates between November 2025 and February 2026, include detailed information on the revised precautions and summaries of the underlying investigation results. This guidance serves to inform drug manufacturers about necessary updates to product labeling and safety information.

Drug manufacturers must review these revisions to ensure their product labeling and internal safety protocols align with the updated precautions. While specific compliance deadlines for manufacturers are not explicitly stated beyond the effective dates of the revisions, it is critical to implement these changes promptly to maintain regulatory compliance and patient safety. Failure to adhere to updated safety information could lead to regulatory action or impact product market authorization.

What to do next

Review the list of drug precaution revisions for FY2025 published by PMDA.
Identify all affected drugs manufactured by the organization.
Update product labeling and internal safety documentation to reflect the revised precautions by their respective effective dates.

Source document (simplified)

日本語ページはこちら
| Date | Nonproprietary name | Detailed information on revisions of PRECAUTIONS
(from MHLW) | Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable) |
| --- | --- | --- | --- |
| February24,2026 | - Colchicine | PRECAUTIONS
[91.9 KB] | Summary of Investigation
[76.8 KB] |
| February10,2026 | - Cytarabine
- Daunorubicin hydrochloride | PRECAUTIONS
[28 KB] | Summary of Investigation
[67 KB] |
| - Axitinib | PRECAUTIONS
[26 KB] | Summary of Investigation
[65 KB] | |
| - Ibrutinib | PRECAUTIONS
[26 KB] | Summary of Investigation
[62 KB] | |
| - Fruquintinib | PRECAUTIONS
[26 KB] | Summary of Investigation
[62 KB] | |
| - Aciclovir (oral dosage form)
- Aciclovir (injection)
- Valaciclovir hydrochloride | PRECAUTIONS
[26 KB] | Summary of Investigation
[98 KB] | |
| - Riociguat | PRECAUTIONS
[27 KB] | Report on Investigation
[416 KB] | |
| - Lonafarnib | PRECAUTIONS
[33 KB] | Report on Investigation
[416 KB] | |
| - Ensitrelvir fumaric acid | PRECAUTIONS
[123 KB] | Report on Investigation
[416 KB] | |
| January 13, 2026 | - Aspirin (preparations indicated for prevention of thrombus and embolus formation)
- Aspirin/dialuminate
- Aspirin/vonoprazan fumarate
- Aspirin/lansoprazole
- Clopidogrel sulfate/aspirin
- Aspirin (preparations indicated for antipyresis/analgesia/anti-inflammation) | PRECAUTIONS
[26.8 KB] | Summary of Investigation
[87 KB] |
| - Imeglimin hydrochloride | PRECAUTIONS
[24.8 KB] | Summary of Investigation
[60 KB] | |
| - Burosumab (genetical recombination) | PRECAUTIONS
[28.4 KB] | Summary of Investigation
[61.3 KB] | |
| - Preparations containing aspirin
(OTC drug)