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 |
|---|---|---|---|---|
| July 26, 2024 | Purified pineapple stem juice | Application site haemorrhage | － | － |
| Alacepril Imidapril hydrochloride Captopril Delapril hydrochloride Perindopril erbumine |
Hepatic impairment | － | － | |
| Azelnidipine Olmesartan medoxomil/ azelnidipine Posaconazole Fosravuconazole L-lysine ethanolate |
Precautions for concomitant use of preparations containing azelnidipine with posaconazole or fosravuconazole L-lysine ethanolate |
－ | － | |
| Pemafibrate | Hepatic impairment, jaundice | － | － | |
| Mirogabalin besilate | Renal impairment | － | － | |
| Preparations containing sulfamethoxazole sodium (OTC antibacterial ophthalmic solution) Preparations containing sulfamethoxazole (OTC antibacterial ophthalmic solution) |
Shock (anaphylaxis) | － | － | |
| Iodixanol | Acute generalised exanthematous pustulosis | － | － | |
| Sodium valproate | Precautions for neurodevelopmental disorder in infants/children with paternal exposure to sodium valproate | － | － | |
| Aspirin Ampiroxicam Ibuprofen Esflurbiprofen and mentha oil Etodolac Ketoprofen Celecoxib Nabumetone Naproxen Piroxicam Bucolome Flurbiprofen Flurbiprofen axetil Mefenamic acid Loxoprofen sodium hydrate Lornoxicam Ethenzamide Sodium salicylate/ dibucaine hydrochloride/ calcium bromide Zaltoprofen Sulpyrine hydrate Salicylamide/acetaminophen/ anhydrous caffeine/ chlorpheniramine maleate Salicylamide/acetaminophen/ anhydrous caffeine/ promethazine methylenedisalicylate Isopropylantipyrin/ acetaminophen/ allylisopropylacetylurea/ anhydrous caffeine Flufenamate aluminum Ibuprofen piconol Indometacin (dermatologic preparation) Diclofenac etalhyaluronate sodium Diclofenac sodium (dermatologic preparation) Salicylic acid Methyl salicylate Methyl salicylate and glycyrrhetinic acid combination drug Salicylic acid adhesive plaster Suprofen Methyl salicylate/ dl-camphor/capsicum extract Methyl salicylate/ dl-camphor/l-menthol Glycol salicylate/l-menthol Felbinac Suprarenal extract/ heparinoid/salicylic acid Aspirin/dialuminate Aspirin/ vonoprazan fumarate Aspirin/lansoprazole Clopidogrel sulfate/ aspirin |
Constriction of the foetal ductus arteriosus | － | － | |
| 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 [40.4 KB] |
| 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 [54.3 KB] | Press Announcement from the FDA Review report of AVASTIN 100mg/4mL Intravenous Infusion and AVASTIN 400mg/16mL Intravenous Infusion on July 14, 2011 (only in Japanese) [1,708 KB] |
－ |