This webpage provides drug risk information which has come under review by the PMDA and the Ministry of Health, Labour and Welfare (MHLW). Information provided here is as follows:
- Risk information suggested by a certain amount of accumulated information of adverse drug reactions (ADR) reports or Early Post-marketing Phase Vigilance (EPPV)
Safety measures such as revision of PRECAUTIONS in the package insert of the product might be taken after the ongoing review.
*When evaluations are completed, the information in the table below will be deleted. You will find the results of evaluation on the “Revisions of PRECAUTIONS” webpage. - Risk information which has attracted the attention of foreign regulatory agencies or academic societies based on studies published in scientific journals, etc., for which the PMDA and MHLW have started their evaluation since the risk information is related to drugs marketed in Japan
Information provided here is still under review. If you are taking the following drugs, you should NOT stop taking them or reduce the dosage without consulting a physician. Consult your healthcare professionals if you have any questions or concerns about these drugs.
| Posted Date | Nonproprietary Name | Risk Information of Ongoing Evaluation | Related Information | Investigation Results |
|---|---|---|---|---|
| April 5, 2024 | Rivaroxaban Posaconazole |
Precautions for concomitant use of rivaroxaban and posaconazole | − | − |
| April 5, 2024 |
Brimonidine tartrate |
Corneal opacity | − | − |
| April 5, 2024 | Colistin sodium methanesulfonate Erythromycin lactobionate/colistin sodium methanesulfonate Chloramphenicol/colistin sodium methanesulfonate |
Hypokalaemia, hypomagnesaemia, hypocalcaemia, metabolic alkalosis | − | − |
| April 5, 2024 | Amoxicillin hydrate Potassium clavulanate/ amoxicillin hydrate Vonoprazan fumarate/ amoxicillin hydrate/clarithromycin Vonoprazan fumarate/ amoxicillin hydrate/metronidazole Rabeprazole sodium/ amoxicillin hydrate/clarithromycin Rabeprazole sodium/ amoxicillin hydrate/metronidazole |
Drug-induced enterocolitis syndrome | − | − |
| December 26, 2013 | Recombinant absorbed bivalent human papillomavirus-like particle vaccine Recombinant adsorbed quadrivalent human papillomavirus virus-like particle vaccine |
Symptoms related to pain | − | Summary of the Report on the Surveillance Results of HPV Vaccines |
| Posted Date | Nonproprietary Name | Risk Information of Ongoing Evaluation | Related Information | Investigation Results |
|---|---|---|---|---|
| November 30, 2011 | Bevacizumab (genetical recombination) | Japan's view on Avastin (bevacizumab) for breast cancer indication | Press Announcement from the FDA Review report of AVASTIN 100mg/4mL Intravenous Infusion and AVASTIN 400mg/16mL Intravenous Infusion on July 14, 2011 (Japanese text only) |
− |