| 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 in Pharmaceuticals and Medical Devices Safety Information (PMDSI) |
| March 31, 2020 |
Spiperone
Timiperone
Timiperone
Pipamperone hydrochloride |
PRECAUTIONS
[48.06 KB] |
Investigation
[201.36 KB] |
- |
Sultopride hydrochloride
Fluphenazine decanoate |
PRECAUTIONS
[50.60 KB] |
Investigation
[201.36 KB] |
- |
Sulpiride
Sulpiride
Sulpiride
Sulpiride |
PRECAUTIONS
[38.75 KB] |
Investigation
[201.36 KB] |
- |
| Nemonapride |
PRECAUTIONS
[38.65 KB] |
Investigation
[201.36 KB] |
- |
Haloperidol
Haloperidol
Haloperidol decanoate
Bromperidol
Mosapramine hydrochloride |
PRECAUTIONS
[35.62 KB] |
Investigation
[201.36 KB] |
- |
| Pimozide |
PRECAUTIONS
[36.90 KB] |
Investigation
[201.36 KB] |
- |
Blonanserin
Blonanserin
Perospirone hydrochloride
hydrate |
PRECAUTIONS
[39.73 KB] |
Investigation
[201.36 KB] |
- |
| Aclatonium napadisilate |
PRECAUTIONS
[35.75 KB] |
Investigation
[201.36 KB] |
- |
Pegfilgrastim
(genetical recombination) |
PRECAUTIONS
[69.31 KB] |
Investigation
[223.14 KB]
Appendix:
A pharmacoepidemiological study on the association between G-CSF preparations and decreased platelet counts
[411.89 KB] |
- |
Pembrolizumab
(genetical recombination) |
PRECAUTIONS
[3.85 KB] |
Investigation
[138.28 KB] |
PMDSI No. 372 |
Aciclovir
(oral dosage forms)
Aciclovir
(injectable
dosage forms)
Valaciclovir hydrochloride |
PRECAUTIONS
[50.92 KB] |
Investigation
[143.10 KB] |
- |
| Amenamevir |
PRECAUTIONS
[52.13 KB] |
Investigation
[133.95 KB] |
- |
Baloxavir
marboxil |
PRECAUTIONS
[53.08 KB] |
Investigation
[135.03 KB] |
- |
February
25,
2020 |
Rotigotine |
PRECAUTIONS
[50.26 KB] |
Investigation
[240.40 KB] |
PMDSI No. 371 |
| Allopurinol |
PRECAUTIONS
[54.41 KB] |
Investigation
[144.85 KB] |
- |
| Arsenic trioxide |
PRECAUTIONS
[52.00 KB] |
Investigation
[145.27 KB] |
- |
Asunaprevir
Glecaprevir
hydrate/
pibrentasvir
Sofosbuvir
Daclatasvir hydrochloride
Ledipasvir
acetonate/
sofosbuvir |
PRECAUTIONS
[50.52 KB] |
Investigation
[145.25 KB]
Appendix:
A study on the effect of hepatitis C drugs on blood coagulability in patients on warfarin
[259.41 KB] |
- |
Elbasvir
Grazoprevir
hydrate |
PRECAUTIONS
[40.07 KB] |
Investigation
[145.25 KB]
Appendix:
A study on the effect of hepatitis C drugs on blood coagulability in patients on warfarin
[259.41 KB] |
- |
Sofosbuvir/
velpatasvir |
PRECAUTIONS
[60.22 KB] |
Investigation
[145.25 KB]
Appendix:
A study on the effect of hepatitis C drugs on blood coagulability in patients on warfarin
[259.41 KB] |
- |
Daclatasvir hydrochloride/
asunaprevir/
beclabuvir hydrochloride |
PRECAUTIONS
[52.23 KB] |
Investigation
[145.25 KB]
Appendix:
A study on the effect of hepatitis C drugs on blood coagulability in patients on warfarin
[259.41 KB] |
- |
Fosravuconazole
L-lysine
ethanolate |
PRECAUTIONS
[49.56 KB] |
Investigation
[148.47 KB] |
- |
Aminolevulinic acid
hydrochloride |
PRECAUTIONS
[49.72 KB] |
Investigation
[160.60 KB] |
PMDSI No. 371 |
January
21,
2020 |
Levodopa
Levodopa
Levodopa/
carbidopa
hydrate
Levodopa/
benserazide hydrochloride |
PRECAUTIONS
[53.72 KB] |
Investigation
[148.10 KB] |
- |
Levodopa/
carbidopa
hydrate/
entacapone |
PRECAUTIONS
[53.24 KB] |
Investigation
[148.10 KB] |
- |
Olmesartan medoxomil
Olmesartan medoxomil/
azelnidipine |
PRECAUTIONS
[53.34 KB] |
Investigation
[132.84 KB] |
PMDSI No. 370 |
| Ipragliflozin L-Proline |
PRECAUTIONS
[36.35 KB] |
Investigation
[133.34 KB] |
PMDSI No. 370 |
Sitagliptin phosphate hydrate/
ipragliflozin L-Proline |
PRECAUTIONS
[36.39 KB] |
Investigation
[133.34 KB] |
- |
Secukinumab
(genetical recombination) |
PRECAUTIONS
[124.46 KB] |
Investigation
[143.50 KB] |
PMDSI No. 370 |
Alemtuzumab
(genetical recombination) |
PRECAUTIONS
[66.01 KB] |
Investigation
[122.70 KB] |
- |
December
3,
2019 |
Mecasermin
(genetical recombination) |
PRECAUTIONS
[42.67 KB] |
Investigation
[25.23 KB] |
- |
Atezolizumab
(genetical recombination) |
PRECAUTIONS
[56.41 KB] |
Investigation
[141.15 KB] |
PMDSI No. 369 |
| Osimertinib mesilate |
PRECAUTIONS
[41.98 KB] |
Investigation
[40.10 KB] |
PMDSI No. 369 |
| Bilastine |
PRECAUTIONS
[40.06 KB] |
Investigation
[121.83 KB] |
PMDSI No. 369 |
November
15,
2019 |
Apalutamide |
PRECAUTIONS
[53.83 KB] |
Investigation
[133.56 KB] |
- |
| Enzalutamide |
PRECAUTIONS
[53.83 KB] |
Investigation
[134.93 KB] |
- |
November
12,
2019 |
Urokinase
(60 000 units) |
PRECAUTIONS
[53.79 KB] |
Material of the 9th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019
[1.03 MB]
(Only in Japanese) |
- |
October
29,
2019 |
Methylphenidate hydrochloride
(sustained-
release tablets) |
PRECAUTIONS
[37.06 KB] |
Points for Consideration concerning the Use of Methylphenidate Hydrochloride Preparations (Concerta Tablets 18 mg, 27 mg, 36 mg)
[153.73 KB]
Appendix: Outline of Logistic Management Implemented by Manufacturing Authorization Holders
[444.26 KB]
(Both only in Japanese) |
- |
October
29,
2019 |
Vonoprazan fumarate |
PRECAUTIONS
[67.66 KB] |
Investigation
[163.51 KB] |
PMDSI No. 368 |
Vonoprazan fumarate/
amoxicillin
hydrate/
clarithromycin
Vonoprazan fumarate/
amoxicillin
hydrate/
metronidazole |
PRECAUTIONS
[52.33 KB] |
Investigation
[163.51 KB] |
- |
D-Sorbitol
(urologic
irrigating
solution) |
PRECAUTIONS
[62.41 KB] |
Investigation
[130.72 KB] |
- |
Belimumab
(genetical recombination) |
PRECAUTIONS
[66.86 KB] |
Investigation
[134.48 KB] |
- |
September
24,
2019 |
Baricitinib |
PRECAUTIONS
[39.28 KB] |
Investigation
[148.60 KB] |
PMDSI No. 367 |
| Osimertinib mesilate |
PRECAUTIONS
[68.96 KB] |
Investigation
[134.88 KB] |
PMDSI No. 367 |
Ofloxacin
(oral dosage
form) |
PRECAUTIONS
[42.01 KB] |
Investigation
[246.41 KB] |
- |
| Garenoxacin mesilate hydrate |
PRECAUTIONS
[40.64 KB] |
Investigation
[246.41 KB] |
- |
| Sitafloxacin hydrate |
PRECAUTIONS
[38.66 KB] |
Investigation
[246.41 KB] |
- |
Ciprofloxacin
Ciprofloxacin
hydrochloride hydrate |
PRECAUTIONS
[40.72 KB] |
Investigation
[246.41 KB] |
- |
Tosufloxacin tosilate hydrate
(oral dosage
form) |
PRECAUTIONS
[42.67 KB] |
Investigation
[246.41 KB] |
- |
Norfloxacin
(oral dosage
form) |
PRECAUTIONS
[38.28 KB] |
Investigation
[246.41 KB] |
- |
| Pazufloxacin mesilate |
PRECAUTIONS
[38.32 KB] |
Investigation
[246.41 KB] |
- |
| Pipemidic acid hydrate |
PRECAUTIONS
[41.35 KB] |
Investigation
[246.41 KB] |
- |
| Prulifloxacin |
PRECAUTIONS
[40.40 KB] |
Investigation
[246.41 KB] |
- |
Moxifloxacin hydrochloride
(oral dosage
form) |
PRECAUTIONS
[40.42 KB] |
Investigation
[246.41 KB] |
- |
Levofloxacin hydrate
(oral dosage
form)
Levofloxacin hydrate
(injectable dosage form) |
PRECAUTIONS
[42.66 KB] |
Investigation
[246.41 KB] |
- |
Lomefloxacin hydrochloride
(oral dosage
form) |
PRECAUTIONS
[41.96 KB] |
Investigation
[246.41 KB] |
- |
Tocilizumab
(genetical recombination) |
PRECAUTIONS
[58.57 KB] |
Investigation
[168.72 KB] |
- |
September
6,
2019 |
Romosozumab
(genetical recombination) |
PRECAUTIONS
[76.06 KB] |
Investigation
[34.73 KB] |
- |
September
6,
2019 |
Trelagliptin succinate |
PRECAUTIONS
[168.01 KB] |
Investigation
[773.37 KB] |
- |
August
22,
2019 |
Apomorphine hydrochloride hydrate |
PRECAUTIONS
[43.10 KB] |
Investigation
[249.35 KB] |
- |
| Talipexole hydrochloride |
PRECAUTIONS
[46.33 KB] |
Investigation
[249.35 KB] |
- |
| Pramipexole hydrochloride hydrate |
PRECAUTIONS
[145.58 KB] |
Investigation
[249.35 KB] |
- |
| Pramipexole hydrochloride hydrate |
PRECAUTIONS
[44.24 KB] |
Investigation
[249.35 KB] |
- |
Bromocriptine mesilate
Pergolide
mesilate |
PRECAUTIONS
[43.19 KB] |
Investigation
[249.35 KB] |
- |
| Rotigotine |
PRECAUTIONS
[44.05 KB] |
Investigation
[249.35 KB] |
- |
| Ropinirole hydrochloride |
PRECAUTIONS
[45.45 KB] |
Investigation
[249.35 KB] |
- |
| Cabergoline |
PRECAUTIONS
[150.74 KB] |
Investigation
[249.35 KB]
Investigation
[137.85 KB] |
- |
Tofacitinib
citrate |
PRECAUTIONS
[49.69 KB] |
Investigation
[154.70 KB] |
- |
Freeze-dried
BCG vaccine |
PRECAUTIONS
[43.00 KB] |
Investigation
[33.24 KB] |
PMDSI No. 366 |
July
17,
2019 |
Suxamethonium chloride hydrate
Suxamethonium chloride hydrate |
PRECAUTIONS
[51.86 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[2.55 MB] |
- |
| Etilefrine hydrochloride |
PRECAUTIONS
[48.84 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[985.85 KB] |
- |
| Phenylephrine hydrochloride |
PRECAUTIONS
[49.02 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[985.85 KB] |
- |
| Ozagrel sodium |
PRECAUTIONS
[49.47 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[5.21 MB] |
- |
Purified tuberculin
Purified tuberculin |
PRECAUTIONS
[58.19 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.61 MB] |
- |
July
9,
2019 |
Febuxostat |
PRECAUTIONS
[52.87 KB] |
Investigation
[607.98 KB] |
- |
| Topiroxostat |
PRECAUTIONS
[49.43 KB] |
Investigation
[607.98 KB] |
- |
July
9,
2019 |
Epoprostenol sodium |
PRECAUTIONS
[53.96 KB] |
Investigation
[131.00 KB] |
- |
Nivolumab
(genetical recombination) |
PRECAUTIONS
[44.04 KB] |
Investigation
[136.34 KB] |
PMDSI No. 365 |
Pembrolizumab
(genetical recombination) |
PRECAUTIONS
[68.63 KB] |
Investigation
[136.34 KB] |
- |
| Palbociclib |
PRECAUTIONS
[58.03 KB] |
Investigation
[36.16 KB] |
PMDSI No. 365 |
Cedar pollen extract powder
Dermatophagoides pteronyssinus extract/
dermatophagoides farina extract |
PRECAUTIONS
[51.94 KB] |
Investigation
[141.22 KB] |
- |
Standardized cedar pollen extract
(liquid, those for sublingual administration only)
Dermatophagoides pteronyssinus extract bulk powder/
dermatophagoides farinae extract bulk powder |
PRECAUTIONS
[50.76 KB] |
Investigation
[141.22 KB] |
- |
Tramadol hydrochloride
(oral dosage
form)
Tramadol hydrochloride/
acetaminophen |
PRECAUTIONS
[55.36 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.86 MB] |
- |
Tramadol hydrochloride
(injection) |
PRECAUTIONS
[52.85 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.86 MB] |
- |
Codeine phosphate hydrate
(prescription drugs)
Codeine phosphate hydrate
(prescription drugs)
Codeine phosphate hydrate
(prescription drugs)
Dihydrocodeine phosphate
(prescription drugs)
Dihydrocodeine phosphate
(prescription drugs)
Dihydrocodeine phosphate
(prescription drugs) |
PRECAUTIONS
[52.54 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.86 MB] |
- |
Dihydrocodeine phosphate/
platycodon fluidextract/
glycyrrhiza extract/
plantago herb extract/
peony root extract
(prescription drugs)
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
(prescription drugs)
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
(prescription drugs)
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
(prescription drugs)
Dihydrocodeine phosphate/
diprophylline/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/
bromovalerylurea (prescription drugs)
Dihydrocodeine phosphate/
ephedrine hydrochloride/
ammonium chloride
(prescription drugs) |
PRECAUTIONS
[53.29 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.86 MB] |
- |
Products containing codeine phosphate hydrate
(OTC drugs)
Products containing dihydrocodeine phosphate
(OTC drugs) |
PRECAUTIONS
[144.27 KB] |
Material of the 4th Committee on Drug Safety of the Pharmaceutical Affairs and Food Sanitation Council in FY2019 (Only in Japanese)
[1.86 MB] |
- |
June
18,
2019 |
Metformin Hydrochloride(preparations with a daily maximum dose of 2 250 mg) |
PRECAUTIONS
[139.66 KB] |
Investigation
[480.23 KB] |
- |
| Metformin Hydrochloride(preparations with a maximum daily dose of 750 mg) |
PRECAUTIONS
[122.81 KB] |
Investigation
[480.23 KB] |
- |
Anagliptin/
metformin hydrochloride |
PRECAUTIONS
[118.38 KB] |
Investigation
[480.23 KB] |
- |
Alogliptin benzoate/
metformin hydrochloride |
PRECAUTIONS
[115.62 KB] |
Investigation
[480.23 KB] |
- |
Pioglitazone hydrochloride/
metformin hydrochloride |
PRECAUTIONS
[123.61 KB] |
Investigation
[480.23 KB] |
- |
Vildagliptin/
metformin hydrochloride |
PRECAUTIONS
[118.34 KB] |
Investigation
[480.23 KB] |
- |
June
4,
2019 |
Eletriptan hydrobromide
Zolmitriptan
Naratriptan hydrochloride
Rizatriptan benzoate |
PRECAUTIONS
[154.05 KB] |
Investigation
[151.18 KB] |
- |
Sumatriptan
Sumatriptan succinate
Sumatriptan succinate |
PRECAUTIONS
[152.71 KB] |
Investigation
[151.18 KB] |
- |
| Sumatriptan succinate |
PRECAUTIONS
[150.80 KB] |
Investigation
[151.18 KB] |
- |
Avelumab
(genetical recombination) |
PRECAUTIONS
[49.80 KB] |
Investigation
[129.41 KB] |
- |
Nivolumab
(genetical recombination) |
PRECAUTIONS
[53.33 KB] |
Investigation
[167.87 KB] |
PMDSI No. 364 |
| Pembrolizumab (genetical recombination) |
PRECAUTIONS
[50.25 KB] |
Investigation
[167.87 KB] |
- |
Baloxavir
marboxil |
PRECAUTIONS
[51.74 KB] |
Investigation
[133.25 KB] |
PMDSI No. 364 |
May
20,
2019
May
17,
2019
(Originally Posted in Japanese) |
Abemaciclib |
PRECAUTIONS
[82.87 KB] |
Investigation
[117.68 KB] |
PMDSI No. 364 |
May
9,
2019 |
Dulaglutide
(genetical recombination) |
PRECAUTIONS
[55.10 KB] |
Investigation
[137.26 KB] |
PMDSI No. 363 |
Ipragliflozin L-proline
Tofogliflozin hydrate |
PRECAUTIONS
[162.20 KB] |
Investigation
[245.84 KB] |
- |
| Empagliflozin |
PRECAUTIONS
[161.78 KB] |
Investigation
[245.84 KB] |
PMDSI No. 363 |
Empagliflozin/
linagliptin |
PRECAUTIONS
[153.89 KB] |
Investigation
[245.84 KB] |
- |
| Canagliflozin hydrate |
PRECAUTIONS
[162.07 KB] |
Investigation
[245.84 KB] |
- |
Sitagliptin phosphate hydrate/
ipragliflozin L-proline |
PRECAUTIONS
[155.23 KB] |
Investigation
[245.84 KB] |
- |
| Dapagliflozin propylene glycolate hydrate |
PRECAUTIONS
[178.49 KB] |
Investigation
[245.84 KB] |
- |
Teneligliptin hydrobromide hydrate/
canagliflozin hydrate |
PRECAUTIONS
[162.70 KB] |
Investigation
[245.84 KB] |
- |
| Luseogliflozin hydrate |
PRECAUTIONS
[176.67 KB] |
Investigation
[245.84 KB] |
- |
Nivolumab
(genetical recombination) |
PRECAUTIONS
[50.29 KB] |
Investigation
[141.37 KB] |
PMDSI No. 363 |
| Lenvatinib mesilate |
PRECAUTIONS
[48.60 KB] |
Investigation
[129.36 KB] |
PMDSI No. 363 |
| Influenza HA vaccine |
PRECAUTIONS
[51.63 KB] |
Investigation
[139.05 KB] |
PMDSI No. 363 |
