| 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 23,
2022 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection) |
PRECAUTIONS
[210.69 KB] |
- |
- |
March 15,
2022 |
Ticagrelor |
PRECAUTIONS
[225.05 KB] |
Investigation
[216.86 KB] |
- |
| Nintedanib ethanesulfonate |
PRECAUTIONS
[227.76 KB] |
Investigation
[280.46 KB] |
- |
| Efavirenz |
PRECAUTIONS
[228.41 KB] |
Investigation
[208.34 KB] |
- |
February 3,
2022 |
Levonorgestrel (preparations indicated for emergency contraception) |
PRECAUTIONS
[243.21 KB] |
Investigation
[211.67 KB] |
- |
January 6,
2022 |
Aminolevulinic acid hydrochloride |
PRECAUTIONS
[304.75 KB] |
Investigation
[785.09 KB]
Appendix 10 is not included.
See the Detailed information on revisions of PRECAUTIONS. |
- |
December 17,
2021 |
Blonanserin (oral dosage form) |
PRECAUTIONS
[247.12 KB] |
Investigation
[228.63 KB] |
- |
| Blonanserin (patches) |
PRECAUTIONS
[248.88 KB] |
Investigation
[228.63 KB] |
- |
| Suvorexant |
PRECAUTIONS
[247.46 KB] |
Investigation
[227.88 KB] |
- |
| Fingolimod hydrochloride |
PRECAUTIONS
[241.43 KB] |
Investigation
[212.90 KB] |
PMDSI No. 389 |
Posaconazole
Posaconazole |
PRECAUTIONS
[252.61 KB] |
Investigation
[228.63 KB]
Investigation
[227.88 KB] |
- |
Washed human red blood cell
Synthetic blood
Concentrated human blood platelet
Concentrated human blood platelet |
PRECAUTIONS
[231.66 KB] |
Investigation
[221.10 KB] |
- |
Whole human blood
Human red blood cells |
PRECAUTIONS
[207.42 KB] |
Investigation
[221.10 KB] |
- |
| Frozen-thawed human red blood cells |
PRECAUTIONS
[205.07 KB] |
Investigation
[221.10 KB] |
- |
December 8,
2021 |
Tacrolimus hydrate (ointment) |
PRECAUTIONS
[140.81 KB] |
Re-examination Report [779.39 KB]
(only in Japanese) |
- |
December 3,
2021 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection) |
PRECAUTIONS
[105.95 KB] |
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 73rd meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 23rd meeting) (joint meeting)
(only in Japanese) |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(COVID-19 Vaccine Moderna Intramuscular Injection) |
PRECAUTIONS
[226.35 KB] |
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 73rd meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 23rd meeting) (joint meeting)
(only in Japanese) |
- |
November 16,
2021 |
Atezolizumab (genetical recombination) |
PRECAUTIONS
[226.93 KB] |
Investigation
[226.85 KB] |
PMDSI No. 388 |
October 15,
2021 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(Comirnaty intramuscular injection) |
PRECAUTIONS
[74.73 KB] |
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 70th meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 19th meeting) (joint meeting)
(only in Japanese) |
- |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
(COVID-19 Vaccine Moderna Intramuscular Injection) |
PRECAUTIONS
[27.45 KB] |
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 70th meeting), and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 19th meeting) (joint meeting)
(only in Japanese) |
- |
October 12,
2021 |
Tofacitinib citrate |
PRECAUTIONS
[152.06 KB] |
Investigation
[99.31 KB] |
- |
| Cefoperazone sodium/sulbactam sodium |
PRECAUTIONS
[122.81 KB] |
Investigation
[28.27 KB] |
PMDSI No. 387 |
| Ivermectin |
PRECAUTIONS
[118.53 KB] |
Investigation
[97.27 KB] |
- |
| September 21, 2021 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)(Comirnaty intramuscular injection) |
PRECAUTIONS
[210.05 KB] |
- |
- |
| Coronavirus modified uridine RNA vaccine (SARS-CoV-2)(COVID-19 Vaccine Moderna Intramuscular Injection) |
PRECAUTIONS
[211.19 KB] |
- |
- |
| COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) |
PRECAUTIONS
[229.55 KB] |
- |
- |
September 7,
2021 |
Istradefylline |
PRECAUTIONS
[284.46 KB] |
Investigation
[228.89 KB] |
- |
| Lomitapide mesilate |
PRECAUTIONS
[248.06 KB] |
Investigation
[228.89 KB] |
- |
July 27,
2021 |
COVID-19 (SARS-CoV-2) vaccine (recombinant chimpanzee adenovirus vector) |
PRECAUTIONS
[229.55 KB] |
Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 64th meeting) and the 2021 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 13th meeting)
(Only in Japanese) |
- |
July 20,
2021 |
Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) |
PRECAUTIONS
[212.03 KB] |
Investigation
[253.12 KB] |
PMDSI No. 385 |
| Magnesium sulfate hydrate (preparations indicated for eclampsia) |
PRECAUTIONS
[232.81 KB] |
Investigation
[253.12 KB] |
PMDSI No. 385 |
Hydrocortisone
Hydrocortisone sodium succinate
Hydrocortisone sodium phosphate |
PRECAUTIONS
[228.80 KB] |
Investigation
[283.12 KB] |
- |
| Magnesium sulfate hydrate/glucose (preparations indicated for inhibition of uterine contractions in threatened premature labour, and prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) |
PRECAUTIONS
[213.67 KB] |
Investigation
[229.69 KB] |
PMDSI No. 385 |
Alendronate sodium hydrate
Alendronate sodium hydrate
Zoledronic acid hydrate
Pamidronate disodium hydrate
Minodronic acid hydrate
Sodium risedronate hydrate |
PRECAUTIONS
[239.23 KB] |
Investigation
[253.12 KB] |
- |
Ibandronate sodium hydrate
Ibandronate sodium hydrate
Etidronate disodium |
PRECAUTIONS
[211.07 KB] |
Investigation
[253.12 KB] |
- |
| Denosumab (genetical recombination) |
PRECAUTIONS
[211.40 KB] |
Investigation
[253.12 KB] |
- |
| Romosozumab (genetical recombination) |
PRECAUTIONS
[214.20 KB] |
Investigation
[253.12 KB] |
- |
July 7,
2021 |
Coronavirus modified uridine RNA vaccine (SARS-CoV-2)
Coronavirus modified uridine RNA vaccine (SARS-CoV-2) |
PRECAUTIONS
[218.83 KB] |
Investigation
[419.90 KB] |
- |
June 21,
2021 |
Nivolumab (genetical recombination) |
PRECAUTIONS
[213.54 KB] |
Investigation
[495.69 KB] |
- |
June 15,
2021 |
Ixekizumab (genetical recombination) |
PRECAUTIONS
[73.26 KB] |
Investigation
[74.11 KB] |
PMDSI No. 384 |
| Pembrolizumab (genetical recombination) |
PRECAUTIONS
[40.95 KB] |
Investigation
[28.15 KB] |
PMDSI No. 384 |
June 3,
2021 |
Clozapine |
PRECAUTIONS
[110.22 KB] |
Investigation
[495.69 KB]
Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS |
- |
June 2,
2021
June 1,
2021
(Originally Posted in Japanese) |
Diclofenac etalhyaluronate sodium |
PRECAUTIONS
[71.54 KB] |
Investigation
[105.41 KB]
Blue Letter
[85.85 KB]
Case report
[108.94 KB] |
- |
May 13,
2021 |
Shosaikotokakikyosekko |
PRECAUTIONS
[218.16 KB] |
Investigation
[205.04 KB] |
- |
