| 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) |
March 28,
2019 |
Amobarbital |
PRECAUTIONS
[25.84 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
Secobarbital sodium
Pentobarbital calcium |
PRECAUTIONS
[25.89 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
| Sodium valproate |
PRECAUTIONS
[137.88 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
Cefmenoxime hydrochloride
Cefmenoxime hydrochloride
Cefmenoxime hydrochloride
Ceftibuten hydrate
Cefaclor
Cefazolin sodium
Cefazolin sodium hydrate
Cefalexin
Cefalotin sodium
Cefixime hydrate
Cefepime dihydrochloride hydrate
Cefozopran hydrochloride
Cefotiam hydrochloride
Cefoperazone sodium/sulbactam sodium
Cefcapene pivoxil hydrochloride hydrate
Cefditoren pivoxil
Cefdinir
Ceftazidime hydrate
Ceftizoxime sodium
Cefteram pivoxil
Ceftriaxone sodium hydrate
Cefpirome sulfate
Cefpodoxime proxetil
Cefminox sodium hydrate
Cefmetazole sodium
Cefroxadine hydrate
Flomoxef sodium
Latamoxef sodium |
PRECAUTIONS
[31.71 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
Hydroxyethylated starch 70000
Hydroxyethylated starch 70000/sodium chloride/potassium chloride/calcium chloride hydrate/sodium lactate |
PRECAUTIONS
[26.16 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
| Penicillamine (50 mg, 100 mg) |
PRECAUTIONS
[38.09 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
| Vancomycin hydrochloride (injectable dosage form) |
PRECAUTIONS
[25.92 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
Benzylpenicillin benzathine hydrate
Benzylpenicillin potassium
Amoxicillin hydrate
Amoxicillin hydrate/potassium clavulanate
Ampicillin hydrate
Ampicillin sodium
Ampicillin sodium/sulbactam sodium
Sultamicillin tosilate hydrate
Bacampicillin hydrochloride
Piperacillin sodium
Ampicillin hydrate/cloxacillin sodium hydrate
Ampicillin sodium/cloxacillin sodium hydrate |
PRECAUTIONS
[127.17 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
Imipenem hydrate/cilastatin sodium
Tebipenem pivoxil
Doripenem hydrate
Panipenem/betamipron
Biapenem
Faropenem sodium hydrate
Meropenem hydrate |
PRECAUTIONS
[28.40 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
| Cefotaxime sodium |
PRECAUTIONS
[25.72 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
| Cefuroxime axetil |
PRECAUTIONS
[25.91 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [9.39 MB] |
March 19,
2019 |
Quetiapine fumarate (tablets, fine granules)
Quetiapine fumarate (tablets, fine granules)
Quetiapine fumarate (extended release tablets) |
PRECAUTIONS
[26.23 KB] |
Investigation
[124.25 KB] |
| Clozapine |
PRECAUTIONS
[38.04 KB] |
Investigation
[120.38 KB] |
| Vonoprazan fumarate |
PRECAUTIONS
[26.19 KB] |
Investigation
[132.62 KB] |
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
Vonoprazan fumarate/amoxicillin hydrate/metronidazole |
PRECAUTIONS
[26.43 KB] |
Investigation
[132.62 KB] |
| Denosumab (genetical recombination) (120 mg product) |
PRECAUTIONS
[25.93 KB] |
Investigation
[120.94 KB] |
March 19,
2019 |
Intravenous injection preparations containing sorbitol as excipient |
PRECAUTIONS
[140.13 KB] |
Investigation
[137.46 KB] |
| Intravenous injection preparations containing fructose as excipient |
PRECAUTIONS
[40.15 KB] |
Investigation
[137.46 KB] |
March 1,
2019 |
Oseltamivir phosphate
Oseltamivir phosphate |
PRECAUTIONS
[26.24 KB] |
Investigation
[24.80 KB] |
| Baloxavir marboxil |
PRECAUTIONS
[28.90 KB] |
Investigation
[124.29 KB] |
February 12,
2019 |
Eliglustat tartrate |
PRECAUTIONS
[107.12 KB] |
Investigation
[54.09 KB] |
Trastuzumab (genetical recombination)
Trastuzumab (genetical recombination) follow-on biologic 1
Trastuzumab (genetical recombination) follow-on biologic 2
Trastuzumab (genetical recombination) follow-on biologic 3 |
PRECAUTIONS
[32.85 KB] |
Investigation
[146.28 KB] |
| Nivolumab (genetical recombination) |
PRECAUTIONS
[43.06 KB] |
Investigation
[132.29 KB] |
| Palbociclib |
PRECAUTIONS
[31.33 KB] |
Investigation
[125.91 KB] |
| Pembrolizumab (genetical recombination) |
PRECAUTIONS
[31.23 KB] |
Investigation
[132.34 KB] |
| Glecaprevir hydrate/pibrentasvir |
PRECAUTIONS
[29.86 KB] |
Investigation
[126.60 KB] |
February 8,
2019 |
Eculizumab (genetical recombination) |
PRECAUTIONS
[31.35 KB] |
Material of the 3rd Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) [2.54 MB] |
January 10,
2019 |
Nusinersen sodium |
PRECAUTIONS
[32.08 KB] |
Investigation
[88.49 KB] |
| Axitinib |
PRECAUTIONS
[32.40 KB] |
Investigation
[89.47 KB] |
| Lenalidomide hydrate |
PRECAUTIONS
[33.70 KB] |
Investigation
[100.58 KB] |
Ofloxacin (oral dosage form)
Garenoxacin mesilate hydrate
Ciprofloxacin
Ciprofloxacin
Ciprofloxacin
Ciprofloxacin
Tosufloxacin tosilate hydrate (oral preparations with dosage and administration for pediatric use)
Pazufloxacin mesilate
Moxifloxacin hydrochloride (oral dosage form)
Levofloxacin hydrate (oral dosage form)
Levofloxacin hydrate (oral dosage form)
Levofloxacin hydrate (oral dosage form)
Levofloxacin hydrate (oral dosage form)
Levofloxacin hydrate (oral dosage form)
Levofloxacin hydrate (injectable dosage form)
Levofloxacin hydrate (injectable dosage form)
Lomefloxacin hydrochloride (oral dosage form) |
PRECAUTIONS
[57.56 KB] |
Investigation
[249.84 KB] |
Sitafloxacin hydrate
Sitafloxacin hydrate
Ciprofloxacin hydrochloride hydrate
Tosufloxacin tosilate hydrate (oral preparations without dosage and administration for pediatric use)
Tosufloxacin tosilate hydrate (oral preparations without dosage and administration for pediatric use)
Norfloxacin (oral dosage form)
Norfloxacin (oral dosage form)
Prulifloxacin |
PRECAUTIONS
[60.89 KB] |
Investigation
[249.84 KB] |
Asunaprevir
Daclatasvir hydrochloride
Daclatasvir hydrochloride/asunaprevir/beclabuvir hydrochloride |
PRECAUTIONS
[43.19 KB] |
Investigation
[100.72 KB] |
November 27,
2018 |
Aluminum potassium sulfate hydrate/tannic acid (with saline) |
PRECAUTIONS
[46.40 KB] |
Investigation
[104.15 KB] |
| Aluminum potassium sulfate hydrate/tannic acid (with analgesic agents) |
PRECAUTIONS
[47.82 KB] |
Investigation
[104.15 KB] |
| Calcitriol (injectable dosage form) |
PRECAUTIONS
[44.58 KB] |
Investigation
[98.86 KB] |
| Freeze-dried live attenuated varicella vaccine |
PRECAUTIONS
[45.51 KB] |
Investigation
[103.66 KB] |
October 23,
2018 |
Lamotrigine
Lamotrigine |
PRECAUTIONS
[46.22 KB] |
Investigation
[118.51 KB] |
| Secukinumab (genetical recombination) |
PRECAUTIONS
[99.38 KB] |
Investigation
[104.17 KB] |
| Lenvatinib mesilate |
PRECAUTIONS
[46.12 KB] |
Investigation
[108.80 KB] |
October 16,
2018 |
Atorvastatin calcium hydrate
Atorvastatin calcium hydrate
Ezetimibe/atorvastatin calcium hydrate
Pravastatin sodium
Pravastatin sodium
Pravastatin sodium
Amlodipine basilate/atorvastatin calcium hydrate |
PRECAUTIONS
[59.78 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
| Clinofibrate |
PRECAUTIONS
[49.76 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
| Clofibrate |
PRECAUTIONS
[62.19 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
Simvastatin
Simvastatin |
PRECAUTIONS
[60.32 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
Pitavastatin calcium hydrate
Pitavastatin calcium hydrate |
PRECAUTIONS
[58.31 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
Fenofibrate
Fenofibrate
Bezafibrate
Bezafibrate |
PRECAUTIONS
[59.52 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
| Fluvastatin sodium |
PRECAUTIONS
[59.40 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
| Pemafibrate |
PRECAUTIONS
[60.75 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
Rosuvastatin calcium
Rosuvastatin calcium
Rosuvastatin calcium |
PRECAUTIONS
[58.65 KB] |
Investigation
[400.50 KB]
Appendix 2 is not included. See the Detailed information on revisions of PRECAUTIONS |
September 18,
2018 |
Radium (223Ra) chloride |
PRECAUTIONS
[48.78 KB] |
Investigation
[50.22 KB] |
| Sunitinib malate |
PRECAUTIONS
[44.26 KB] |
Investigation
[96.94 KB] |
Ampicillin hydrate
Ampicillin hydrate
Bacampicillin hydrochloride
Ampicillin sodium/cloxacillin sodium hydrate
Ampicillin sodium/cloxacillin sodium hydrate |
PRECAUTIONS
[46.50 KB] |
Investigation
[173.32 KB] |
| Ampicillin sodium |
PRECAUTIONS
[45.96 KB] |
Investigation
[173.32 KB] |
Sultamicillin tosilate hydrate
Sultamicillin tosilate hydrate |
PRECAUTIONS
[46.12 KB] |
Investigation
[173.32 KB] |
| Ampicillin hydrate/cloxacillin sodium hydrate |
PRECAUTIONS
[45.92 KB] |
Investigation
[173.32 KB] |
| Dolutegravir sodium |
PRECAUTIONS
[48.05 KB] |
Investigation
[105.07KB] |
| Dolutegravir sodium/abacavir sulfate/lamivudine |
PRECAUTIONS
[58.05 KB] |
Investigation
[105.07KB] |
August 21,
2018 |
Amantadine hydrochloride
Amantadine hydrochloride |
PRECAUTIONS
[55.46 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
Oseltamivir phosphate
Oseltamivir phosphate |
PRECAUTIONS
[114.38 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
Zanamivir hydrate
Laninamivir octanoate hydrate |
PRECAUTIONS
[53.51 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
| Baloxavir marboxil |
PRECAUTIONS
[53.37 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
| Favipiravir |
PRECAUTIONS
[53.74 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
| Peramivir hydrate |
PRECAUTIONS
[53.75 KB] |
Material of the 1st Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2018 (Only in Japanese) |
August 2,
2018 |
Apremilast |
PRECAUTIONS
[44.94 KB] |
Investigation
[98.78 KB] |
Ceftriaxone sodium hydrate
Ceftriaxone sodium hydrate
Ceftriaxone sodium hydrate |
PRECAUTIONS
[47.19 KB] |
Investigation
[62.84 KB] |
July 10,
2018 |
Tacrolimus hydrate (ophthalmic solution) |
PRECAUTIONS
[99.94 KB] |
Investigation
[305.49 KB] |
Tacrolimus hydrate (ointment)
Tacrolimus hydrate (ointment) |
PRECAUTIONS
[100.35 KB] |
Investigation
[305.49 KB] |
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (oral dosage form)
Tacrolimus hydrate (injectable dosage form) |
PRECAUTIONS
[110.54 KB] |
Investigation
[305.49 KB] |
| Azathioprine |
PRECAUTIONS
[131.55 KB] |
Investigation
[213.19 KB] |
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (oral dosage form)
Ciclosporin (injectable dosage form) |
PRECAUTIONS
[124.82 KB] |
Investigation
[262.29 KB] |
June 5,
2018 |
Amiodarone hydrochloride
Amiodarone hydrochloride
Amiodarone hydrochloride |
PRECAUTIONS
[46.16 KB] |
Investigation
[118.91 KB] |
Filgrastim (genetical recombination)
Filgrastim (genetical recombination, follow-on biologic 1)
Filgrastim (genetical recombination, follow-on biologic 2)
Filgrastim (genetical recombination, follow-on biologic 3)
Pegfilgrastim (genetical recombination)
Lenograstim (genetical recombination) |
PRECAUTIONS
[56.21 KB] |
Investigation
[147.07 KB] |
Everolimus (tablets 2.5mg/5mg)
Everolimus (dispersible tablets 2mg/3mg) |
PRECAUTIONS
[45.31 KB] |
Investigation
[117.35 KB] |
| Eftrenonacog alfa (genetical recombination) |
PRECAUTIONS
[44.80 KB] |
Investigation
[98.17 KB] |
Metronidazole (oral dosage form)
Metronidazole (injectable dosage form)
Lansoprazole/amoxicillin hydrate/metronidazole
Rabeprazole sodium/amoxicillin hydrate/metronidazole
Vonoprazan fumarate/amoxicillin hydrate/metronidazole |
PRECAUTIONS
[112.17 KB] |
Investigation
[167.22 KB] |
April 19,
2018 |
Omarigliptin
Saxagliptin hydrate
Trelagliptin succinate |
PRECAUTIONS
[44.87 KB] |
Investigation
[104.70 KB] |
| Cladribine |
PRECAUTIONS
[44.95 KB] |
Investigation
[98.49 KB] |
| Pembrolizumab (genetical recombination) |
PRECAUTIONS
[56.82 KB] |
Investigation
[103.54 KB] |
Tosufloxacin tosilate hydrate (for oral use)
Tosufloxacin tosilate hydrate (for oral use)
Tosufloxacin tosilate hydrate (for oral use) |
PRECAUTIONS
[45.29 KB] |
Investigation
[185.13 KB] |
