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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2026)

Report on the Deliberation Results(Japanese only)Report on the Deliberation Results(Japanese only)Report on Investigation Results Date Nonproprietary name Information on revisions of PRECAUTIONS
(from MHLW)
Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable)
August 28, 2026
  • Tucatinib ethanolate
PRECAUTIONS
[144 KB]
Summary of Investigation
[75.3 KB]
  • Palovarotene
PRECAUTIONS
[46.3 KB]
Summary of Investigation
[75.3 KB]
August 25, 2026
  • Acetaminophen
  • Isopropylantipyrine/acetaminophen/
    allylisopropylacetylurea/
    anhydrous caffeine
  • Tramadol hydrochloride/
    acetaminophen
  • Salicylamide/acetaminophen/
    anhydrous caffeine/
    chlorpheniramine maleate
  • Salicylamide/acetaminophen/
    anhydrous caffeine/
    promethazine methylenedisalicylate
  • Diprophylline/
    dihydrocodeine phosphate/
    dl-methylephedrine hydrochloride/
    diphenhydramine salicylate/
    acetaminophen/bromovalerylurea
PRECAUTIONS
[42.3 KB]
Summary of Investigation
[66.7 KB]
  • Olanzapine
    (oral dosage form)
PRECAUTIONS
[47.3 KB]
Report on Investigation
Results [250 KB]

Appendix 5 is not included in this file. See Detailed information on revisions of PRECAUTIONS.
  • Domperidone
PRECAUTIONS
[44.1 KB]
Summary of Investigation 
Results
[55.8 KB]

(Appendix)[188 KB]
Summary of the NBD study
  • Metoclopramide hydrochloride
  • Metoclopramide
PRECAUTIONS
[47.2 KB]
Summary of Investigation 
Results
[55.8 KB]

(Appendix)[188 KB]
Summary of the NBD study
  • Mitotane
PRECAUTIONS
[44.4 KB]
Summary of Investigation
[61.4 KB]
  • Atezolizumab
    (genetical recombination)
  • Avelumab
    (genetical recombination)
  • Durvalumab
    (genetical recombination)
  • Tremelimumab
    (genetical recombination)
PRECAUTIONS
[37.5 KB]
Summary of Investigation
[51.7 KB]
  • Apalutamide
PRECAUTIONS
[37.1 KB]
Summary of Investigation
[86.1 KB]
  • Avelumab
    (genetical recombination)
  • Ipilimumab
    (genetical recombination)
  • Tislelizumab
    (genetical recombination) 
  • Durvalumab
    (genetical recombination) 
  • Tremelimumab
    (genetical recombination)
  • Retifanlimab
    (genetical recombination)
PRECAUTIONS
[36.9 KB]
Summary of Investigation
[54.4 KB]
  • Ipilimumab
    (genetical recombination)
PRECAUTIONS
[39.7 KB]
Summary of Investigation
[45.5 KB]
  • Ivosidenib
PRECAUTIONS
[45.2 KB]
Summary of Investigation
[61.4 KB]
  • Encorafenib
PRECAUTIONS
[45.1 KB]
Summary of Investigation
[61.4 KB]
  • Talaporfin sodium
PRECAUTIONS
[47.6 KB]
Summary of Investigation
[43.2 KB]
  • Nivolumab
    (genetical recombination)
PRECAUTIONS
[37.1 KB]
Summary of Investigation
[45.5 KB]
  • Kakkonto
PRECAUTIONS
[34.8 KB]
Summary of Investigation
[28.9 KB]
  • Elvitegravir/cobicistat/emtricitabine/
    tenofovir alafenamide fumarate
PRECAUTIONS
[44.3 KB]
Summary of Investigation
[61.4 KB]
  • Darunavir ethanolate/cobicistat
PRECAUTIONS
[42.8 KB]
Summary of Investigation
[61.4 KB]
  • Darunavir ethanolate/cobicistat/
    emtricitabine/
    tenofovir alafenamide fumarate
PRECAUTIONS
[44.7 KB]
Summary of Investigation
[61.4 KB]
  • Doravirine
PRECAUTIONS
[42.1 KB]
Summary of Investigation
[61.4 KB]
  • Doravirine/islatravir hydrate
PRECAUTIONS
[45.1 KB]
Summary of Investigation
[61.4 KB]
  • Dolutegravir sodium/
    rilpivirine hydrochloride
PRECAUTIONS
[41.3 KB]
Summary of Investigation
[61.4 KB]
  • Bictegravir sodium/emtricitabine/
    tenofovir alafenamide fumarate
PRECAUTIONS
[41.5 KB]
Summary of Investigation
[61.4 KB]
  • Rilpivirine
PRECAUTIONS
[41.8 KB]
Summary of Investigation
[61.4 KB]
  • Rilpivirine hydrochloride
PRECAUTIONS
[41.2 KB]
Summary of Investigation
[61.4 KB]
  • Rilpivirine hydrochloride/emtricitabine/
    tenofovir alafenamide fumarate
PRECAUTIONS
[41.2 KB]
Summary of Investigation
[61.4 KB]
  • Lenacapavir sodium
PRECAUTIONS
[42.6 KB]
Summary of Investigation
[61.4 KB]
  • OTC drugs containing Kakkonto formulation
PRECAUTIONS
[52.3 KB]
Summary of Investigation
[48.7 KB]
August 24, 2026
  • Freeze-dried Bacillus Calmette-Guérin (BCG) for intravesical use
    (Japanese strain)
PRECAUTIONS
[77.8 KB]
Review report for
durvalumab
(genetical recombination)
​[1,989 KB]

(Japanese only)
August 17, 2026
  • Donanemab
    (genetical recombination)
PRECAUTIONS
[51.1 KB]
Summary of Investigation
[38.4 KB]
  • Lecanemab
    (genetical recombination)
PRECAUTIONS
[63.5 KB]
Summary of Investigation
[38.4 KB]
August 12, 2026
  • Viltolarsen
PRECAUTIONS
[108 KB]
Summary of Investigation
[66.7 KB]
July 14, 2026
  • Esomeprazole Magnesium Hydrate
  • Omeprazole
  • Vonoprazan Fumarate
  • Rabeprazole Sodium
  • Lansoprazole (oral dosage form)
PRECAUTIONS
[57.1 KB]
Summary of Investigation
[136 KB]
  • Omeprazole Sodium
  • Lansoprazole (injection)
PRECAUTIONS
[57.8KB]
Summary of Investigation
[136 KB]
  • Insulin aspart
    (genetical recombination)
    (Fiasp Injection 100U/mL)
PRECAUTIONS
[103 KB]
Summary of Investigation
[99.4 KB]
  • Aspirin/
    Vonoprazan Fumarate
PRECAUTIONS
[56KB]
Summary of Investigation
[136 KB]
  • Aspirin/Lansoprazole
PRECAUTIONS
[64.1 KB]
Summary of Investigation
[136 KB]
  • Guselkumab
    (Genetical Recombination)
PRECAUTIONS
[134 KB]
Summary of Investigation
[128 KB]
  • Doxorubicin hydrochloride
    (liposome formulations)
PRECAUTIONS
[61.1 KB]
Summary of Investigation
[62.3 KB]
  • Atezolizumab
    (Genetical Recombination)
  • Avelumab
    (Genetical Recombination)
  • Ipilimumab
    (Genetical Recombination)
  • Cemiplimab
    (Genetical Recombination)
  • Tislelizumab
    (Genetical Recombination)
  • Durvalumab
    (Genetical Recombination)
  • Tremelimumab
    (Genetical Recombination)
  • Nivolumab
    (Genetical Recombination)
  • Retifanlimab
    (Genetical Recombination)
PRECAUTIONS
[61.5 KB]
Summary of Investigation
[95.6KB]
  • Ixazomib Citrate
PRECAUTIONS
[60.9 KB]
Summary of Investigation
[54.4 KB]
  • Carboplatin
PRECAUTIONS
[58.6 KB]
Summary of Investigation
[55.8 KB]
  • Nivolumab
    (Genetical Recombination)
PRECAUTIONS
[60.5 KB]
Summary of Investigation
[62.3 KB]
  • Vonoprazan Fumarate/
    Amoxicillin Hydrate/Clarithromycin
  • Vonoprazan Fumarate/
    Amoxicillin Hydrate/Metronidazole
PRECAUTIONS
[70.7 KB]
Summary of Investigation
[136 KB]
  • Recombinant RS virus vaccine (Abrysvo)
  • Recombinant RS virus vaccine (Arexvy)
PRECAUTIONS
[110 KB]
Summary of Investigation
[103 KB]
  • Anti-human thymocyte immunoglobulin, rabbit
PRECAUTIONS
[120 KB]
Summary of Investigation
[109KB]
  • Preparations containing omeprazole
    (guidance-mandatory drugs)
PRECAUTIONS
[79.9KB]
Summary of Investigation
[30.3 KB]
  • Preparations containing rabeprazole sodium
    (guidance-mandatory drugs)
PRECAUTIONS
[81.4 KB]
Summary of Investigation
[30.3 KB]
  • Preparations containing lansoprazole
    (guidance-mandatorydrugs)
PRECAUTIONS
[80.9KB]
Summary of Investigation
[30.3 KB]
June 30, 2026
  • Cefcapene pivoxil hydrochloride hydrate
PRECAUTIONS
[51.4 KB]
Summary of Investigation
[93.9 KB]
  • Cefditoren pivoxil
PRECAUTIONS
[51.3 KB]
Summary of Investigation
[93.9 KB]
  • Cefteram pivoxil
PRECAUTIONS
[51.2 KB]
Summary of Investigation
[93.9 KB]
  • Tebipenem pivoxil
PRECAUTIONS
[51.3 KB]
Summary of Investigation
[93.9 KB]
June 16, 2026
  • Lithium carbonate
PRECAUTIONS
[65.4 KB]
Report on Investigation
[126 KB]
  • Ferric carboxymaltose
  • Saccharated ferric oxide
PRECAUTIONS
[58.1 KB]

PRECAUTIONS
[58.3 KB]
Summary of Investigation
[24.6 KB]
  • Valemetostat tosilate
PRECAUTIONS
[138 KB]
Summary of Investigation
[43.5 KB]
  • Sulfamethoxazole/trimethoprim
    (oral dosage form)
  • Sulfamethoxazole/trimethoprim (injection)
PRECAUTIONS
[57.3 KB]

PRECAUTIONS
[57.2 KB]
Summary of Investigation
[35.1 KB]
June 5, 2026
  • Donanemab
    (genetical recombination)
PRECAUTIONS
[43.3 KB]
Summary of Investigation
[71.2 KB]
  • Lecanemab
    (genetical recombination)
PRECAUTIONS
[44.4 KB]
Summary of Investigation
[29.9 KB]
May 21, 2026
  • Avacopan
PRECAUTIONS
[97 KB]
Investigation
[62 KB]

Blue Letter
[226 KB]
April 21, 2026
  • Infliximab
    (genetical recombination) and biosimilars
  • Etanercept
    (genetical recombination) and biosimilars
PRECAUTIONS
[26.5KB]
Summary of Investigation
[73.8 KB]
  • Calcium chloride hydrate (injection)
PRECAUTIONS
[32.4 KB]
Summary of Investigation
[131 KB]
  • Calcium gluconate hydrate
PRECAUTIONS
[31.4 KB]
Summary of Investigation
[131 KB]
  • Avelumab
    (genetical recombination)
PRECAUTIONS
[25.6 KB]
Summary of Investigation
[79.8 KB]
  • Regorafenib hydrate
PRECAUTIONS
[25.6 KB]
Summary of Investigation
[78.6 KB]