| Posted date |
Nonproprietary name
(Click on each drug name for more information
[only available in Japanese language]) |
Detailed information on revisions of PRECAUTIONS
(from MHLW) |
Summary of
investigation results
(from PMDA) |
Reference article (Important Safety Information) in Pharmaceuticals and Medical Devices Safety Information (PMDSI) |
| March 27, 2023 |
Anti-human thymocyte immunoglobulin, rabbit |
 |
- |
- |
| March 23, 2023 |
Borofalan (10B) |
|
|
PMDSI 400 |
| Enviomycin sulfate |
|
|
- |
| Cycloserine |
- |
| Aluminoparaaminosalicylate calcium hydrate |
- |
| Isoniazid |
- |
| Isoniazid |
- |
| Isoniazid sodium methanesulfonate hydrate |
- |
| Ethionamide |
- |
| Calcium paraaminosalicylate hydrate |
- |
| Pyrazinamide |
- |
| Bedaquiline fumarate |
- |
| Kanamycin sulfate |
|
- |
| Streptomycin sulfate |
- |
| Rifabutin |
|
- |
| Rifampicin |
|
- |
| Ethambutol hydrochloride |
- |
| Levofloxacin hydrate (oral dosage form) |
- |
| Delamanid |
|
- |
| February 14, 2023 |
Exenatide |
|
|
PMDSI 399 |
| Semaglutide (genetical recombination) |
| Semaglutide (genetical recombination) |
| Dulaglutide (genetical recombination) |
| Lixisenatide |
| Liraglutide (genetical recombination) |
| Insulin glargine (genetical recombination)/lixisenatide |
| Insulin degludec (genetical recombination)/liraglutide (genetical recombination) |
| Tirzepatide |
|
| Tazobactam/piperacillin hydrate |
|
|
PMDSI 399 |
January 17, 2023
*February 10, 2023
Administrative Notice of Partial Correction |
Acetaminophen
(oral dosage form) |
|
|
PMDSI 398 |
Acetaminophen
(oral dosage form) |
| Acetaminophen (suppositories) |
Tramadol hydrochloride/
acetaminophen |
| Non-pyrine common cold medicine |
| Non-pyrine common cold medicine |
| Non-pyrine common cold medicine |
| Non-pyrine common cold medicine |
| Non-pyrine common cold medicine |
Diprophylline/
dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/ bromovalerylurea |
| Acetaminophen (injections) |
|
| Pyrazolone-based antipyretics, analgesics and anti-inflammatory combination drug |
| Clopidogrel sulfate |
|
|
PMDSI 398 |
| Clopidogrel sulfate/aspirin |
| Alendronate sodium hydrate |
|
Appendix: Database study using MID-NET® on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations |
- |
| Alendronate sodium hydrate |
- |
| Ibandronate sodium hydrate |
|
- |
| Ibandronate sodium hydrate |
- |
| Etidronate disodium |
|
- |
| Zoledronic acid hydrate (preparations indicated for osteoporosis) |
|
- |
| Minodronic acid hydrate |
|
- |
| Sodium risedronate hydrate |
|
- |
| Hydroxychloroquine sulfate |
|
|
- |
| Imatinib mesilate |
|
|
- |
| Oral live attenuated human rotavirus vaccine |
|
|
PMDSI 398 |
| Preparations containing acetaminophen (oral dosage form) (OTC drugs) |
(corrected version) |
|
PMDSI 398 |
| Acetaminophen (suppositories) (OTC drugs) |
| January 12, 2023 |
Hydroxyethylated starch 70000 |
|
Appendix 7 is not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
| Hydroxyethylated starch 70000/sodium chloride/potassium chloride/calcium chloride hydrate/sodium lactate |
- |
| Hydroxyethylated starch 130000 |
|
- |
| December 5, 2022 |
Amlodipine besilate |
|
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
| Nifedipine |
|
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS. |
- |
| November 16, 2022 |
Hydrochlorothiazide |
|
|
PMDSI 397 |
Candesartan cilexetil/
hydrochlorothiazide |
|
Valsartan/
hydrochlorothiazide |
Losartan potassium/
hydrochlorothiazide |
|
| Roxadustat |
|
|
PMDSI 397 |
| Imatinib mesilate |
|
|
PMDSI 397 |
| 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 |
|
- |
| October 20, 2022 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.1), Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5)) |
|
- |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intramuscular Injection (Bivalent: Original/Omicron BA.1)) |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection (Monovalent: Original)) |
|
- |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intramuscular Injection (Monovalent: Original)) |
|
- |
- |
| October 12, 2022 |
Pemafibrate |
|
(References) Material for the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 13th meeting) (Only in Japanese) |
- |
| October 12, 2022 |
Loxoprofen sodium hydrate (oral dosage form) (prescription drug) |
|
|
- |
| Methotrexate |
|
|
PMDSI 396 |
| Methotrexate |
| Methotrexate |
| Methotrexate |
| Ipilimumab (genetical recombination) |
|
|
- |
| Nivolumab (genetical recombination) |
|
- |
| Pembrolizumab (genetical recombination) |
|
- |
| Itraconazole (tablets, capsules) |
|
|
- |
| Itraconazole (oral solution) |
|
- |
| Itraconazole (injections) |
|
- |
| Preparations containing loxoprofen sodium hydrate (oral dosage form) (OTC drugs) |
|
|
- |
| September 13, 2022 |
Riociguat |
|
|
- |
| Atazanavir sulfate |
|
- |
| Ritonavir |
|
- |
| Lopinavir/ritonavir |
|
- |
| August 30, 2022 |
Hydroxychloroquine sulfate |
|
|
- |
| Ramucirumab (genetical recombination) |
|
|
PMDSI 395 |
| July 20, 2022 |
Eszopiclone |
|
|
- |
| Zopiclone |
|
- |
| Zolpidem tartrate |
|
- |
| Triazolam |
|
|
| - |
|
- |
| Avelumab (genetical recombination) |
|
|
PMDSI 394 |
| Durvalumab (genetical recombination) |
PMDSI 394 |
| Bortezomib |
|
|
- |
Posaconazole
Posaconazole |
|
|
- |
| Iopamidol |
|
|
- |
| Iohexol |
- |
| Iomeprol |
|
- |
July 8,
2022 |
Recombinant COVID-19 (SARS-CoV-2) vaccine
(Nuvaxovid Intramuscular Injection) |
|
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 81st meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 6th meeting) (joint meeting) (Only in Japanese) |
- |
| June 14, 2022 |
Cetuximab sarotalocan sodium (genetical recombination) |
|
|
PMDSI 393 |
| Nivolumab (genetical recombination) |
|
|
- |
| Pembrolizumab (genetical recombination) |
- |
| Vonoprazan fumarate/amoxicillin hydrate/metronidazole |
|
|
- |
| Rabeprazole sodium/amoxicillin hydrate/metronidazole |
- |
| Nirmatrelvir/ritonavir |
|
|
PMDSI 393 |
| Molnupiravir |
|
|
PMDSI 393 |
| Metronidazole (oral dosage form) |
|
|
- |
| Metronidazole (injections) |
|
- |
| June 10, 2022 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection) |
|
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 80th meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 5th meeting) (joint meeting) (Only in Japanese) |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection for 5 to 11 years old) |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection)) |
- |
May 13,
2022 |
Dexamethasone (oral dosage form) (preparations indicated for pituitary suppression tests) |
|
|
PMDSI 392 |
| Dexamethasone (oral dosage form) (preparations not indicated for pituitary suppression tests) |
|
| Dexamethasone palmitate |
| Dexamethasone sodium phosphate (injections) |
|
| Betamethasone (oral dosage form) |
|
| Betamethasone (suppositories) |
|
| Betamethasone acetate/betamethasone sodium phosphate |
| Betamethasone sodium phosphate (enemas) |
Betamethasone/
d-chlorpheniramine maleate |
|
| Betamethasone sodium phosphate (injections) |
| Teicoplanin |
|
|
- |
April 26,
2022 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection) |
|
- |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection)) |
|
- |
- |
April 4,
2022 |
Interferon beta-1a (genetical recombination) |
|
Appendix 5 and 6 are not included.
See the Detailed information on revisions of PRECAUTIONS. |
- |
| Interferon beta-1b (genetical recombination) |
|
- |
April 4,
2022 |
Somatropin (genetical recombination) |
|
Appendix 5 is not included.
See the Detailed information on revisions of PRECAUTIONS. |
- |
|
|
|
