| 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) |
PRECAUTIONS
[37.02 KB] |
Investigation
[33.79 KB] |
PMDSI No. 409 |
| February 15, 2024 |
Topiramate |
PRECAUTIONS
[30.53 KB] |
Investigation
[29.28 KB] |
PMDSI No. 408 |
Nintedanib ethanesulfonate
Axitinib
Aflibercept beta (genetical recombination)
Cabozantinib malate
Sunitinib malate
Sorafenib tosilate
Pazopanib hydrochloride
Vandetanib
Ponatinib hydrochloride
Ramucirumab (genetical recombination)
Regorafenib hydrate
Lenvatinib mesilate |
PRECAUTIONS
[30.15 KB] |
Investigation
[40.78 KB]
Appendix: Evaluation of the risk of artery dissection due to systemic exposure to VEGF/VEGFR inhibitors
[438.64 KB] |
- |
Linezolid
Linezolid |
PRECAUTIONS
[30.48 KB] |
Investigation
[51.90 KB] |
- |
| Itraconazole |
PRECAUTIONS
[28.26 KB] |
Investigation
[35.85 KB] |
- |
| February 8, 2024 |
Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Gobik Aqueous Suspension Syringes) |
PRECAUTIONS
[27.19 KB] |
- |
- |
| Adsorbed diphtheria-purified pertussis-tetanus-inactivated polio-Haemophilus type b conjugate combined vaccine (Quintovac Aqueous Suspension Injection) |
PRECAUTIONS
[122.87 KB] |
- |
- |
| January 10, 2024 |
Sertraline hydrochloride |
PRECAUTIONS
[124.93 KB] |
Investigation
[137.87 KB]
Appendix: Evaluation of the effect of antidepressants on indices of decreased platelet count using MID-NET
[125.17 KB] |
- |
Acetazolamide
Acetazolamide sodium |
PRECAUTIONS
[117.11 KB] |
Investigation
[132.14 KB] |
PMDSI No. 407 |
| Cortisone acetate |
PRECAUTIONS
[115.42 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
| Dexamethasone (oral dosage form) (preparations indicated for multiple myeloma) |
PRECAUTIONS
[117.40 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
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 |
PRECAUTIONS
[132.36 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
| Dexamethasone palmitate |
PRECAUTIONS
[117.10 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
Hydrocortisone sodium succinate (preparations not indicated for lymphoid tumours)
Hydrocortisone sodium phosphate |
PRECAUTIONS
[122.61 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
| Prednisolone sodium phosphate |
PRECAUTIONS
[113.65 KB] |
Investigation
[1.10 MB] |
PMDSI No. 407 |
| Atezolizumab (genetical recombination) |
PRECAUTIONS
[114.01 KB] |
Investigation
[119.85 KB] |
PMDSI No. 407 |
Encorafenib
Binimetinib |
PRECAUTIONS
[115.69 KB] |
Investigation
[148.48 KB] |
PMDSI No. 407 |
| Pembrolizumab (genetical recombination) |
PRECAUTIONS
[114.27 KB] |
Investigation
[122.42 KB] |
PMDSI No. 407 |
| November 24, 2023 |
Nivolumab (genetical recombination) |
PRECAUTIONS
[121.11 KB] |
- |
- |
| November 21, 2023 |
Metyrapone |
PRECAUTIONS
[28.51 KB] |
Investigation
[111.01 KB] |
PMDSI No. 406 |
Apixaban
Edoxaban tosilate hydrate
Dabigatran etexilate methanesulfonate
Rivaroxaban |
PRECAUTIONS
[29.13 KB] |
Investigation
[48.59 KB] |
PMDSI No. 406 |
| Warfarin potassium |
PRECAUTIONS
[30.71 KB] |
Investigation
[48.59 KB] |
PMDSI No. 406 |
Technetium (99mTc) galactosyl human serum albumin diethylenetriamine
pentaacetic acid |
PRECAUTIONS
[26.94 KB] |
Investigation
[28.03 KB] |
PMDSI No. 406 |
| October 12, 2023 |
Acetaminophen (oral dosage form)
Acetaminophen (oral dosage form) |
PRECAUTIONS
[41.80 KB] |
Investigation
[377.02 KB]
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
- |
| Acetaminophen (injections) |
PRECAUTIONS
[33.76 KB] |
Investigation
[377.02 KB]
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
- |
| Acetaminophen (suppository) |
PRECAUTIONS
[40.47 KB] |
Investigation
[377.02 KB]
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
- |
Tramadol hydrochloride/
acetaminophen |
PRECAUTIONS
[45.47 KB] |
Investigation
[377.02 KB]
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
- |
Diprophylline/dihydrocodeine
phosphate/dl-methylephedrine
hydrochloride/diphenhydramine salicylate/acetaminophen/
bromovalerylurea |
PRECAUTIONS
[33.06 KB] |
Investigation
[377.02 KB]
Appendix 3 is not included. See the detailed information on revisions of PRECAUTIONS. |
- |
| October 12, 2023 |
Filgrastim (genetical recombination)
Filgrastim (genetical recombination, biosimilar 1)
Filgrastim (genetical recombination, biosimilar 2) |
PRECAUTIONS
[120.26 KB] |
Investigation
[93.45 KB] |
- |
Pegfilgrastim (genetical recombination)
Pegfilgrastim (genetical recombination, biosimilar 1) |
PRECAUTIONS
[113.79 KB] |
Investigation
[93.45 KB] |
- |
| Lenograstim (genetical recombination) |
PRECAUTIONS
[26.95 KB] |
Investigation
[93.45 KB] |
- |
| Diazoxide |
PRECAUTIONS
[29.84 KB] |
Investigation
[27.94 KB] |
- |
| Apalutamide |
PRECAUTIONS
[27.52 KB] |
Investigation
[27.15 KB] |
PMDSI No. 405 |
| Ipilimumab (genetical recombination) |
PRECAUTIONS
[25.72 KB] |
Investigation
[74.94 KB] |
- |
| Technetium (99mTc) tetrofosmin |
PRECAUTIONS
[26.50 KB] |
Investigation
[27.36 KB] |
PMDSI No. 405 |
| COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) |
PRECAUTIONS
[27.22 KB] |
Investigation
[28.32 KB] |
- |
| Adenosine |
PRECAUTIONS
[27.32 KB] |
Investigation
[26.46 KB] |
- |
August 29,
2023 |
Rivastigmine |
PRECAUTIONS
[32.77 KB] |
Investigation
[28.38 KB] |
PMDSI No. 404 |
| Finasteride |
PRECAUTIONS
[31.70 KB] |
Investigation
[53.24 KB]
Appendix: Summary of Disproportionality Analysis Using VigiBase
[119.72 KB] |
- |
| Dabigatran etexilate methanesulfonate |
PRECAUTIONS
[28.02 KB] |
Investigation
[75.82 KB] |
PMDSI No. 404 |
| Peficitinib hydrobromide |
PRECAUTIONS
[26.72 KB] |
Investigation
[27.85 KB] |
PMDSI No. 404 |
Cefazolin sodium
Cefazolin sodium hydrate |
PRECAUTIONS
[31.08 KB] |
Investigation
[47.79 KB] |
- |
July 20,
2023 |
Atorvastatin calcium hydrate
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 |
PRECAUTIONS
[122.29 KB] |
Investigation
[140.61 KB]
Appendix: Summary of Disproportionality Analysis Using VigiBase
[52.48 KB] |
PMDSI No. 403 |
| Tirzepatide |
PRECAUTIONS
[26.11 KB] |
Investigation
[28.07 KB] |
- |
Minocycline hydrochloride
(oral dosage form)
Minocycline hydrochloride (injections) |
PRECAUTIONS
[28.92 KB] |
Investigation
[38.84 KB] |
- |
| Ensitrelvir fumaric acid |
PRECAUTIONS
[26.31 KB] |
Investigation
[27.45 KB] |
- |
June 13,
2023 |
Ipilimumab (genetical recombination) |
PRECAUTIONS
[26.12 KB] |
Investigation
[120.22 KB] |
PMDSI No. 402 |
| Nivolumab (genetical recombination) |
PRECAUTIONS
[25.97 KB] |
Investigation
[120.22 KB] |
PMDSI No. 402 |
May 30,
2023 |
Haemophilus influenzae type b conjugate vaccine (tetanus toxoid conjugate) |
PRECAUTIONS
[28.36 KB] |
- |
- |
May 9,
2023 |
Azilsartan
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 |
PRECAUTIONS
[41.74 KB] |
Investigation
[234.42 KB] |
PMDSI No. 401 |
| Sacubitril valsartan sodium hydrate |
PRECAUTIONS
[35.67 KB] |
Investigation
[234.42 KB] |
PMDSI No. 401 |
Mesalazine
Mesalazine |
PRECAUTIONS
[31.87 KB] |
Investigation
[32.22 KB] |
PMDSI No. 401 |
Zinc acetate hydrate
Zinc acetate hydrate |
PRECAUTIONS
[26.31 KB] |
Investigation
[27.41 KB] |
PMDSI No. 401 |
| Leflunomide |
PRECAUTIONS
[31.10 KB] |
Investigation
[27.86 KB] |
- |
Ampicillin hydrate
Ampicillin sodium |
PRECAUTIONS
[26.74 KB] |
Investigation
[47.87 KB] |
- |
Ampicillin hydrate/
cloxacillin sodium hydrate
Ampicillin sodium/
cloxacillin sodium hydrate |
PRECAUTIONS
[28.67 KB] |
Investigation
[47.87 KB] |
- |
| Ioversol |
PRECAUTIONS
[28.64 KB] |
Investigation
[32.80 KB] |
- |
