| 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) |
| October 8, 2024 |
Aspirin (preparations
indicated for
antipyresis/analgesia/
anti-inflammation) |
PRECAUTIONS [71.5 KB] |
Summary of
Investigation 2
[182 KB] |
|
| Acemetacin |
PRECAUTIONS [93.4 KB] |
Summary of
Investigation 1
[122 KB]
(Appendix)
Summary of
the NDB study
[1,395 KB] |
|
Indometacin
(suppositories) |
|
| Indometacin farnesil |
|
| Oxaprozin |
|
Tiaramide
hydrochloride |
|
Proglumetacin
maleate |
|
| Meloxicam |
|
| Ampiroxicam |
PRECAUTIONS [96.9 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
Summary of
the NDB study
[1,395 KB] |
|
| Ibuprofen |
|
| Etodolac |
|
| Naproxen |
|
Piroxicam
(oral dosage form) |
|
Flurbiprofen
(oral dosage form) |
|
| Flurbiprofen axetil |
|
Loxoprofen sodium
hydrate
(oral dosage form) |
|
| Lornoxicam |
|
Isopropylantipyrine/
acetaminophen/
allylisopropylacetylurea/
anhydrous caffeine |
PRECAUTIONS [74.2 KB] |
Summary of
Investigation 2
[182 KB] |
|
Salicylamide/
acetaminophen/
anhydrous caffeine/
chlorpheniramine
maleate |
|
Salicylamide/
acetaminophen/
anhydrous caffeine/
chlorpheniramine
maleate |
|
Salicylamide/
acetaminophen/
anhydrous caffeine/
promethazine
methylenedisalicylate |
|
Salicylamide/
acetaminophen/
anhydrous caffeine/
promethazine
methylenedisalicylate |
|
Salicylamide/
acetaminophen/
anhydrous caffeine/
promethazine
methylenedisalicylate |
|
| Ethenzamide |
PRECAUTIONS [73.3 KB] |
|
| Sulpyrine hydrate |
|
Ketoprofen
(injections) |
PRECAUTIONS [75.5 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
Summary of
the NDB study
[1,395 KB] |
|
Ketoprofen
(suppositories) |
|
| Zaltoprofen |
PRECAUTIONS [96.1 KB] |
|
Dibucaine
hydrocholoride/
sodium salicylate/
calcium bromide |
PRECAUTIONS [73.6 KB] |
Summary of
Investigation 2
[182 KB] |
|
| Celecoxib |
PRECAUTIONS [73.3 KB] |
|
| Celecoxib |
|
| Nabumetone |
PRECAUTIONS [75.0 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
Summary of
the NDB study
[1,395 KB] |
|
| Bucolome |
|
| Mefenamic acid |
|
Flufenamate
aluminum |
PRECAUTIONS [96.2 KB] |
|
Ibuprofen
piconol |
PRECAUTIONS [73.7 KB] |
Summary of
Investigation 2
[182 KB] |
|
Indometacin
(patches) |
|
Diclofenac sodium
(dermatologic
preparation) |
|
Piroxicam
(dermatologic
preparation) |
|
Flurbiprofen
(dermatologic preparation) |
|
Loxoprofen sodium
hydrate
(dermatologic
preparation) |
|
Loxoprofen sodium
hydrate
(dermatologic
preparation) |
Indometacin
(topical preparations
excluding patches) |
PRECAUTIONS [73.1 KB] |
|
Esflurbiprofen/
mentha oil |
PRECAUTIONS [96.4 KB] |
Summary of
Investigation 1
[122 KB]
Summary of
Investigation 2
[182 KB]
(Appendix)
Summary of
the NDB study
[1,395 KB] |
|
Ketoprofen
(dermatologic
preparation) |
PRECAUTIONS [73.1 KB] |
Summary of
Investigation 2
[182 KB] |
|
Glycol salicylate/
l-menthol |
PRECAUTIONS [73.5 KB] |
|
| Methyl salicylate |
|
Methyl salicylate/
dl-camphor/
capsicum extract |
|
Methyl salicylate/
dl-camphor/
l-menthol |
|
Methyl salicylate/
l-menthol/
dl-camphor/
glycyrrhetinic acid |
|
| Felbinac |
|
Heparinoid/
adrenal extract/
salicylic acid |
|
| Salicylic acid |
|
| Salicylic acid |
|
| Salicylic acid |
|
Diclofenac
etalhyaluronate
sodium |
PRECAUTIONS [72.7 KB] |
|
| Preparations containing ibuprofen (OTC drugs) |
PRECAUTIONS
[70.4 KB] |
Summary of
Investigation 3
[93.2 KB] |
|
| Preparations containing naproxen (guidance-mandatory drugs) |
|
| Preparations containing loxoprofen sodium hydrate (oral dosage form) (guidance-mandatory drugs, OTC drugs) |
|
| August 27, 2024 |
Sodium valproate |
PRECAUTIONS
[31.8 KB] |
Summary of
Investigation
[56.2 KB] |
|
| Mirogabalin besilate |
PRECAUTIONS
[20.3 KB] |
Summary of
Investigation
[33.1 KB]
(Appendix 1)
Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET)
[225 KB]
(Appendix 2)
Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET
[216 KB] |
|
| Azelnidipine |
PRECAUTIONS
[107 KB] |
Summary of
Investigation
[148KB] |
|
Olmesartan
medoxomil/
azelnidipine |
PRECAUTIONS
[96.9 KB] |
|
| Posaconazole |
PRECAUTIONS
[15.5 KB] |
|
| Posaconazole |
|
Fosravuconazole
L-lysine ethanolate |
PRECAUTIONS
[15.8 KB] |
|
| Pemafibrate |
PRECAUTIONS
[13.0 KB] |
Summary of
Investigation
[31.8 KB] |
|
Purified pineapple
stem juice |
PRECAUTIONS
[14.2 KB] |
Summary of
lnvestigation
[32.5 KB] |
|
| Iodixanol |
PRECAUTIONS
[13.0 KB] |
Summary of
Investigation
[31.7 KB] |
|
Preparations containing sulfamethoxazole sodium
(OTC antibacterial ophthalmic solution) |
PRECAUTIONS
[16.1 KB] |
Summary of
Investigation
[112 KB] |
|
| Preparations containing sulfamethoxazole (OTC antibacterial ophthalmic solution) |
|
| July 17, 2024 |
Epoprostenol sodium
|
PRECAUTIONS
[25.7 KB] |
Summary of
Investigation
[128 KB] |
PMDSI No.412 |
Pabinafusp alfa
(genetical
recombination) |
PRECAUTIONS
[95.2 KB] |
Summary of
Investigation
[114 KB] |
|
| Daprodustat |
PRECAUTIONS
[98.6 KB] |
Summary of
Investigation
[30.9 KB] |
|
Ipilimumab (genetical
recombination) |
PRECAUTIONS
[89.8 KB] |
Summary of
Investigation
[125 KB] |
PMDSI No.412 |
Nivolumab (genetical
recombination) |
Tirabrutinib
hydrochloride |
PRECAUTIONS
[123 KB] |
Summary of
Investigation
[107 KB] |
PMDSI No.412 |
| Regorafenib hydrate |
PRECAUTIONS
[105 KB] |
Summary of
Investigation
[115 KB] |
|
| Gadobutrol |
PRECAUTIONS
[94.4 KB] |
Summary of
Investigation
[35.0 KB] |
PMDSI No.412 |
| July 4, 2024 |
Freeze-dried smallpox vaccine prepared in cell culture |
PRECAUTIONS
[127 KB] |
－ |
|
| June 11, 2024 |
Brimonidine tartrate |
PRECAUTIONS
[14.5 KB] |
Summary of
Investigation
[115 KB] |
PMDSI No.411 |
Brimonidine tartrate/
brinzolamide |
Ripasudil
hydrochloride hydrate/
brimonidine tartrate |
|
Brimonidine tartrate/
timolol maleate |
PRECAUTIONS
[14.4 KB] |
|
| Finerenone |
PRECAUTIONS
[17.9 KB] |
Summary of
Investigation
[121 KB] |
|
| Posaconazole |
PRECAUTIONS
[14.9 KB] |
|
| Posaconazole |
|
| Voriconazole |
PRECAUTIONS
[17.5 KB] |
|
| Voriconazole |
|
| Carglumic acid |
PRECAUTIONS
[14.9 KB] |
Summary of
Investigation
[27.4 KB] |
|
May 17,
2024 |
Pembrolizumab
(genetical
recombination) |
PRECAUTIONS
[34.37 KB] |
－ |
|
|
May 8, 2024
|
Rivaroxaban
|
PRECAUTIONS [116 KB]
|
Summary of
Investigation
[121 KB]
|
|
|
Colistin sodium
methanesulfonate
(injections)
|
PRECAUTIONS [108 KB]
|
Summary of
Investigation
[162 KB]
|
|
|
Amoxicillin hydrate
|
PRECAUTIONS [112 KB]
|
Summary of
Investigation
[142 KB]
|
|
|
Potassium
clavulanate/
amoxicillin hydrate
|
|
|
Posaconazole
|
PRECAUTIONS [119 KB]
|
Summary of
Investigation
[121 KB]
|
|
|
Posaconazole
|
|
|
Vonoprazan fumarate/
amoxicillin hydrate/
clarithromycin
|
PRECAUTIONS [117 KB]
|
Summary of
Investigation
[142 KB]
|
|
|
Vonoprazan fumarate/
amoxicillin hydrate/
metronidazole
|
|
|
Rabeprazole sodium/
amoxicillin hydrate/
clarithromycin
|
|
|
Rabeprazole sodium/
amoxicillin hydrate/
metronidazole
|
|
| April 9, 2024 |
Bisoprolol fumarate |
PRECAUTIONS [152 KB] |
Report on
Investigation
[248 KB] Appendix 4 is not included in this file. See PRECAUTIONS. |
|
| Bisoprolol |
PRECAUTIONS [153 KB] |
|
| Carvedilol |
PRECAUTIONS [149 KB] |
Report on
Investigation
[236 KB] Appendix 4 is not included in this file. See PRECAUTIONS. |
|
