Pmda - Pharmaceuticals and Medical Devices Agency
Menu
Close

Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2026)

Date Nonproprietary name Information on revisions of PRECAUTIONS
(from MHLW)
Summary of
investigation results
(from PMDA)
Reference article note)
(if applicable)
July 14,2026
  • Esomeprazole Magnesium Hydrate
  • Omeprazole
  • Vonoprazan Fumarate
  • Rabeprazole Sodium
  • Lansoprazole (oral dosage form)
PRECAUTIONS
[57.1 KB]
Summary of Investigation
[136KB]
  • 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
[128KB]
  • 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]