This site provides information on risks and other information regarding pharmaceuticals that are currently being evaluated by the PMDA and the Ministry of Health, Labour and Welfare.
The following items are eligible for publication:
This information is distributed via email as PMDA medi-navi. If you wish to receive this information in a timely manner, we recommend that you register with PMDA medi-navi .
- Risk information of interest that may lead to Revision of PRECAUTIONS, etc.
This is risk information suggested by a certain accumulation of adverse drug reactions reports and Early Post-marketing Phase Vigilance, etc., and the Ministry of Health, Labour and Welfare and PMDA are currently evaluating its relevance to pharmaceuticals, but are paying attention to it as it may lead to Revision of PRECAUTIONS, etc. (Note) If the Revision of PRECAUTIONS, the information listed will be posted on the "Instructions for Revision of PRECAUTIONS" page.
- Risk information that has attracted the attention of foreign regulatory authorities and academic societies, and that the Ministry of Health, Labor and Welfare and PMDA have begun to evaluate
Based on the results of research papers, etc., foreign regulatory authorities and academic societies have been paying attention to this information, and the Ministry of Health, Labor and Welfare and PMDA have begun to evaluate it as risk information related to pharmaceuticals used in Japan.
[general information] Provision of Drug safety Information (PFSB/SD No. 0715 No. 3) [138.65KB]
[To all patients]
The information on this page is currently being evaluated.
Please do not stop taking your medication or reduce the dosage on your own judgment.
| Publication date | Generic Name of the drug | Risk information under evaluation | Related information | Evaluation results |
|---|---|---|---|---|
| 2026 January 16th |
Acyclovir (oral and injectable) Valacyclovir hydrochloride |
Acute generalized exanthematous pustulosis | － | － |
| Ibrutinib | uveitis | － | － | |
| Cytarabine Daunorubicin Hydrochloride | Tumor lysis syndrome | － | － | |
| Fruquintinib | Nephrotic syndrome | － | － | |
| Axitinib | Acute pancreatitis | － | － | |
| 2013 December 26 |
Recombinant adsorbed bivalent human papillomavirus-like particle vaccines (derived from cells of the nettle looper) Recombinant adsorbed quadrivalent human papillomavirus-like particle vaccines (derived from yeast) |
Pain-related symptoms | － | Report [1.01MB] |
| Publication date | Generic Name of the drug | Risk information under evaluation | Related information | Evaluation results |
|---|---|---|---|---|
| 2011 November 30 |
Bevacizumab (genetical recombination) | Removal of Avastin's indication for breast cancer in the United States [131.78KB] |
FDA Publication (November 18, 2011) review report for Avastin for Intravenous Infusion, dated July 14, 2011 [1.67MB] |
－ |