| Posted date |
Nonproprietary name
(Click on each drug name for more information
[only in Japanese ]) |
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 28, 2024 |
Andexanet alfa (genetical recombination) |
 |
|
PMDSI No. 409 |
| February 15, 2024 |
Topiramate |
|
|
PMDSI No. 408 |
| Nintedanib ethanesulfonate |
|
Appendix: Evaluation of the risk of artery dissection due to systemic exposure to VEGF/VEGFR inhibitors |
|
| Axitinib |
| Aflibercept beta (genetical recombination) |
| Cabozantinib malate |
| Sunitinib malate |
| Sorafenib tosilate |
| Pazopanib hydrochloride |
| Vandetanib |
| Ponatinib hydrochloride |
| Ramucirumab (genetical recombination) |
| Regorafenib hydrate |
| Lenvatinib mesilate |
| Linezolid |
|
|
|
| Linezolid |
| Itraconazole |
|
|
|
| February 8, 2024 |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Gobik Aqueous Suspension Syringes) |
|
- |
|
| Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Quintovac Aqueous Suspension Injection) |
|
- |
|
| January 10, 2024 |
Sertraline hydrochloride |
|
Appendix: Evaluation of the effect of antidepressants on indices of decreased platelet count using MID-NET® |
|
| Acetazolamide |
|
|
PMDSI No. 407 |
| Acetazolamide sodium |
| Cortisone acetate |
|
|
PMDSI No. 407 |
| Dexamethasone (oral dosage form) (preparations indicated for multiple myeloma) |
|
| Dexamethasone (oral dosage form) (preparations indicated for lymphoid tumours) |
|
| Dexamethasone sodium phosphate (injections) |
| Hydrocortisone |
| Hydrocortisone sodium succinate (preparations indicated for lymphoid tumours) |
| Prednisolone (oral dosage form) |
| Prednisolone sodium succinate |
| Methylprednisolone |
| Methylprednisolone sodium succinate |
| Methylprednisolone acetate |
| Dexamethasone palmitate |
|
| Hydrocortisone sodium succinate (preparations not indicated for lymphoid tumours) |
|
| Hydrocortisone sodium phosphate |
| Prednisolone sodium phosphate |
|
| Atezolizumab (genetical recombination) |
|
|
PMDSI No. 407 |
| Encorafenib |
|
|
PMDSI No. 407 |
| Binimetinib |
| Pembrolizumab (genetical recombination) |
|
|
PMDSI No. 407 |
| November 24, 2023 |
Nivolumab (genetical recombination) |
|
- |
|
| November 21, 2023 |
Metyrapone |
|
|
PMDSI No. 406 |
| Apixaban |
|
|
PMDSI No. 406 |
| Edoxaban tosilate hydrate |
| Dabigatran etexilate methanesulfonate |
| Rivaroxaban |
| Warfarin potassium |
|
Technetium (99mTc) galactosyl human serum albumin diethylenetriamine
pentaacetic acid |
|
|
PMDSI No. 406 |
| October 12, 2023 |
Acetaminophen (oral dosage form) |
|
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
|
| Acetaminophen (oral dosage form) |
|
| Acetaminophen (injections) |
|
|
| Acetaminophen (suppository) |
|
|
Tramadol hydrochloride/
acetaminophen |
|
|
Diprophylline/dihydrocodeine
phosphate/dl-methylephedrine
hydrochloride/diphenhydramine salicylate/acetaminophen/
bromovalerylurea |
|
|
| October 12, 2023 |
Filgrastim (genetical recombination) |
|
|
- |
| Filgrastim (genetical recombination, biosimilar 1) |
- |
| Filgrastim (genetical recombination, biosimilar 2) |
- |
| Pegfilgrastim (genetical recombination) |
|
- |
| Pegfilgrastim (genetical recombination, biosimilar 1) |
- |
| Lenograstim (genetical recombination) |
|
- |
| Diazoxide |
|
|
- |
| Apalutamide |
|
|
PMDSI No. 405 |
| Ipilimumab (genetical recombination) |
|
|
- |
| Technetium (99mTc) tetrofosmin |
|
|
PMDSI No. 405 |
| COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) |
|
|
- |
| Adenosine |
|
|
- |
August 29,
2023 |
Rivastigmine |
|
|
PMDSI No. 404 |
| Finasteride |
|
Appendix: Summary of Disproportionality Analysis Using VigiBase |
- |
| Dabigatran etexilate methanesulfonate |
|
|
PMDSI No. 404 |
| Peficitinib hydrobromide |
|
|
PMDSI No. 404 |
| Cefazolin sodium |
|
|
- |
| Cefazolin sodium hydrate |
- |
July 20,
2023 |
Atorvastatin calcium hydrate |
|
Appendix: Summary of Disproportionality Analysis Using VigiBase |
PMDSI No. 403 |
| Ezetimibe/atorvastatin calcium hydrate |
| Ezetimibe/rosuvastatin calcium |
| Simvastatin |
| Pitavastatin calcium hydrate |
| Pitavastatin calcium hydrate/ezetimibe |
| Pravastatin sodium |
| Fluvastatin sodium |
| Rosuvastatin calcium |
Amlodipine basilate/
atorvastatin calcium hydrate |
| Tirzepatide |
|
|
- |
Minocycline hydrochloride
(oral dosage form) |
|
|
- |
| Minocycline hydrochloride (injections) |
- |
| Ensitrelvir fumaric acid |
|
|
- |
June 13,
2023 |
Ipilimumab (genetical recombination) |
|
|
- |
| Nivolumab (genetical recombination) |
|
PMDSI No. 402 |
May 30,
2023 |
Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) |
|
- |
- |
May 9,
2023 |
Azilsartan |
|
|
PMDSI No. 401 |
| Azilsartan |
| Azilsartan/amlodipine besilate |
| Alacepril |
| Aliskiren fumarate |
| Imidapril hydrochloride |
| Irbesartan |
| Irbesartan/amlodipine besilate |
| Irbesartan/trichlormethiazide |
| Enalapril maleate |
| Olmesartan medoxomil |
Olmesartan medoxomil/
azelnidipine |
| Captopril |
| Candesartan cilexetil |
Candesartan cilexetil/
amlodipine besilate |
Candesartan cilexetil/
hydrochlorothiazide |
| Temocapril hydrochloride |
| Delapril hydrochloride |
| Telmisartan |
| Telmisartan/amlodipine besilate |
| Telmisartan/amlodipine besilate/hydrochlorothiazide |
| Telmisartan/hydrochlorothiazide |
| Trandolapril |
| Valsartan |
| Valsartan/amlodipine besilate |
| Valsartan/cilnidipine |
| Valsartan/hydrochlorothiazide |
| Benazepril hydrochloride |
| Perindopril erbumine |
| Lisinopril hydrate |
| Losartan potassium |
Losartan potassium/
hydrochlorothiazide |
| Sacubitril valsartan sodium hydrate |
|
| Mesalazine |
|
|
PMDSI No. 401 |
| Mesalazine |
| Zinc acetate hydrate |
|
|
PMDSI No. 401 |
| Zinc acetate hydrate |
| Leflunomide |
|
|
- |
| Ampicillin hydrate |
|
|
- |
| Ampicillin sodium |
- |
Ampicillin hydrate/
cloxacillin sodium hydrate |
|
- |
Ampicillin sodium/
cloxacillin sodium hydrate |
- |
| Ioversol |
|
|
- |
