Revisions of PRECAUTIONS (FY2025)

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Date	Nonproprietary name	Detailed information on revisions of PRECAUTIONS (from MHLW)	Summary of investigation results (from PMDA) Reference article ^note) (if applicable)
February24,2026	Colchicine	PRECAUTIONS [91.9 KB]	Summary of Investigation [76.8 KB]
February10,2026	Cytarabine Daunorubicin hydrochloride	PRECAUTIONS [28 KB]	Summary of Investigation [67 KB]
	Axitinib	PRECAUTIONS [26 KB]	Summary of Investigation [65 KB]
	Ibrutinib	PRECAUTIONS [26 KB]	Summary of Investigation [62 KB]
	Fruquintinib	PRECAUTIONS [26 KB]	Summary of Investigation [62 KB]
	Aciclovir (oral dosage form) Aciclovir (injection) Valaciclovir hydrochloride	PRECAUTIONS [26 KB]	Summary of Investigation [98 KB]
	Riociguat	PRECAUTIONS [27 KB]	Report on Investigation [416 KB]
	Lonafarnib	PRECAUTIONS [33 KB]	Report on Investigation [416 KB]
	Ensitrelvir fumaric acid	PRECAUTIONS [123 KB]	Report on Investigation [416 KB]
January 13, 2026	Aspirin (preparations indicated for prevention of thrombus and embolus formation) Aspirin/dialuminate Aspirin/vonoprazan fumarate Aspirin/lansoprazole Clopidogrel sulfate/aspirin Aspirin (preparations indicated for antipyresis/analgesia/anti-inflammation)	PRECAUTIONS [26.8 KB]	Summary of Investigation [87 KB]
	Imeglimin hydrochloride	PRECAUTIONS [24.8 KB]	Summary of Investigation [60 KB]
	Burosumab (genetical recombination)	PRECAUTIONS [28.4 KB]	Summary of Investigation [61.3 KB]
	Preparations containing aspirin (OTC drug) Preparations containing aspirin aluminum (OTC drug)	PRECAUTIONS [26.8 KB]	Summary of Investigation [59.3 KB]
November 26, 2025	Bosentan hydrate	PRECAUTIONS [24 KB]	Summary of Investigation [73 KB]
	Apixaban	PRECAUTIONS [19 KB]	Summary of Investigation [113 KB] Appendix: [77 KB]
	Edoxaban tosilate hydrate	PRECAUTIONS [20 KB]	Summary of Investigation [113 KB] Appendix: [77 KB]
	Dabigatran etexilate methanesulfonate	PRECAUTIONS [19 KB]	Summary of Investigation [113 KB] Appendix: [77 KB]
	Rivaroxaban	PRECAUTIONS [20 KB]	Summary of Investigation [113 KB] Appendix: [77 KB]
	Warfarin potassium	PRECAUTIONS [21 KB]	Summary of Investigation [113 KB] Appendix: [77 KB]
	Andexanet alfa (genetical recombination)	PRECAUTIONS [28 KB]	Summary of Investigation [55 KB]
	Imiglucerase (genetical recombination)	PRECAUTIONS [21 KB]	Summary of Investigation [55 KB]
	Atezolizumab (genetical recombination)	PRECAUTIONS [19 KB]	Summary of Investigation [72 KB]
	Tosufloxacin tosilate hydrate (oral dosage form)	PRECAUTIONS [20 KB]	Summary of Investigation [67 KB]
October 22, 2025	Lubiprostone	PRECAUTIONS [25.1 KB]	Summary of Investigation [76.3 KB]
	Estradiol (oral dosage form) Estradiol valerate Estriol (oral dosage form) Progesterone (oral dosage form) Estradiol/norethisterone acetate Estradiol/levonorgestrel Testosterone enanthate/ estradiol valerate	PRECAUTIONS [29.6 KB]	Summary of Investigation [143 KB]
	Estradiol (preparations for cutaneous application) estrogens conjugated	PRECAUTIONS [29.7 KB]	Summary of Investigation [143 KB]
	Freeze-dried recombinant herpes zoster vaccine (prepared from Chinese hamster ovary cells)	PRECAUTIONS [25.7 KB]	Summary of Investigation [97.8 KB]
September 17, 2025	Tarlatamab (genetical recombination)	PRECAUTIONS [21.3 KB]	Summary of Investigation [60.9 KB]
September 9, 2025	Azilsartan Azilsartan/amlodipine besilate Candesartan cilexetil Candesartan cilexetil/ amlodipine besilate Candesartan cilexetil/ hydrochlorothiazide	PRECAUTIONS [27.2 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Alacepril	PRECAUTIONS [25.5 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Aliskiren fumarate	PRECAUTIONS [25.5 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Imidapril hydrochloride	PRECAUTIONS [25.9 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Irbesartan Irbesartan/amlodipine besilate Irbesartan/trichlormethiazide	PRECAUTIONS [25.6 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Olmesartan medoxomil Olmesartan medoxomil/azelnidipine Valsartan Valsartan/amlodipine besilate Valsartan/cilnidipine Valsartan/hydrochlorothiazide	PRECAUTIONS [27.3 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Sacubitril valsartan sodium hydrate	PRECAUTIONS [26.1 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Delapril hydrochloride	PRECAUTIONS [25.8 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Telmisartan Telmisartan/amlodipine besilate Telmisartan/amlodipine besilate/hydrochlorothiazide Telmisartan/hydrochlorothiazide	PRECAUTIONS [25.9 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Trandolapril	PRECAUTIONS [26.0 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Perindopril erbumine	PRECAUTIONS [25.8 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Losartan potassium Losartan potassium/hydrochlorothiazide	PRECAUTIONS [25.5 KB]	Summary of Investigation [136 KB] Appendix: [155 KB] Summary of Disproportionality Analysis Using VigiBase
	Mesalazine Salazosulfapyridine	PRECAUTIONS [25.8 KB]	Summary of Investigation [69.5 KB]
	Adalimumab (genetical recombination) Adalimumab (genetical recombination) [adalimumab follow-on biologics 1] Adalimumab (genetical recombination) [adalimumab follow-on biologics 2] Adalimumab (genetical recombination) [adalimumab follow-on biologics 3] Adalimumab (genetical recombination) [adalimumab follow-on biologics 4]	PRECAUTIONS [27.1 KB]	Summary of Investigation [66.7 KB]
	Ipilimumab (genetical recombination)	PRECAUTIONS [26.2 KB]	Summary of Investigation [70.3 KB]
	Nivolumab (genetical recombination)	PRECAUTIONS [26.4 KB]	Summary of Investigation [70.3 KB]
	Meropenem hydrate	PRECAUTIONS [25.4 KB]	Summary of Investigation [66.9 KB]
July 30, 2025	Semaglutide (genetical recombination) Tirzepatide Insulin glargine (genetical recombination)/lixisenatide	PRECAUTIONS [19.5 KB]	Summary of Investigation [84.1 KB] Reference article: PMDSI No.422
	Afatinib maleate Fulvestrant	PRECAUTIONS [24.8 KB]	Summary of Investigation (Afatinib maleate) [61.1 KB] Reference article: PMDSI No.422 Summary of Investigation (Fulvestrant) [60.9. KB] Reference article: PMDSI No.422
	Avelumab (genetical recombination)	PRECAUTIONS [34.1 KB]	Summary of Investigation [62.0 KB]
	Sunitinib malate	PRECAUTIONS [18.4 KB]	Summary of Investigation [61.6 KB] Reference article: PMDSI No.422
	Pembrolizumab (genetical recombination)	PRECAUTIONS [18.4 KB]	Summary of Investigation [65.3 KB] Reference article: PMDSI No.422
June 24, 2025	Desmopressin acetate hydrate (oral dosage form)	PRECAUTIONS [19.8 KB]	Summary of Investigation [65.4 KB]
	Desmopressin acetate hydrate (nasal preparations)	PRECAUTIONS [20.7 KB]	Summary of Investigation [65.4 KB]
	Thiamazole	PRECAUTIONS [13.5 KB]	Summary of Investigation [56.5 KB] Reference article: PMDSI No.421
May 20, 2025	Acetazolamide Acetazolamide sodium	PRECAUTIONS [14.9 KB]	Summary of Investigation [87.6 KB]
	Trichlormethiazide Benzylhydrochlorothiazide Irbesartan/Trichlormethiazide	PRECAUTIONS [13.1 KB]	Summary of Investigation [87.6 KB]
	Hydrochlorothiazide	PRECAUTIONS [14.0 KB]	Summary of Investigation [87.6 KB]
	Mefruside	PRECAUTIONS [12.6 KB]	Summary of Investigation [87.6 KB]
	Indapamide	PRECAUTIONS [60.2 KB]	Summary of Investigation [87.6 KB] Reference article: PMDSI No.420 PMDSI No.420
	Candesartan cilexetil/ hydrochlorothiazide	PRECAUTIONS [14.1 KB]	Summary of Investigation [87.6 KB]
	Telmisartan/amlodipine besilate/ hydrochlorothiazide Telmisartan/hydrochlorothiazide	PRECAUTIONS [14.3 KB]	Summary of Investigation [87.6 KB]
	Valsartan/hydrochlorothiazide	PRECAUTIONS [14.1 KB]	Summary of Investigation [87.6 KB]
	Losartan potassium/ hydrochlorothiazide	PRECAUTIONS [14.1 KB]	Summary of Investigation [87.6 KB]
	Riociguat	PRECAUTIONS [18.5 KB]	Report on Deliberation/ Report on Investigation [724 KB]
	Domperidone (oral dosage form, suppository)	PRECAUTIONS [20.6 KB]	Report on Investigation [148 KB] Appendix 4 is not included in this file. See Detailed information on revisions of PRECAUTIONS.
	Ceritinib	PRECAUTIONS [14.8 KB]	Summary of Investigation [56.0 KB]
	Venetoclax	PRECAUTIONS [26.4 KB]	Summary of Investigation [56.0 KB]
	Borofalan (¹⁰B)	PRECAUTIONS [12.6 KB]	Summary of Investigation [136 KB]
	Nemolizumab (genetical recombination)	PRECAUTIONS [12.4 KB]	Summary of Investigation [55.1 KB] Reference article: PMDSI No.420
	Eplerenone	PRECAUTIONS [16.0 KB]	Summary of Investigation [105 KB]
	Posaconazole (oral dosage form, injections)	PRECAUTIONS [16.6 KB]	Summary of Investigation [105 KB]
	Voriconazole (oral dosage form, injections)	PRECAUTIONS [20.6 KB]	Summary of Investigation [105 KB] Report on Deliberation/ Report on Investigation [724 KB]
	Itraconazole	PRECAUTIONS [20.7 KB]	Report on Deliberation/ Report on Investigation [724 KB]
	Iodixanol	PRECAUTIONS [20.8 KB]	Summary of Investigation [55.7 KB] Reference article: PMDSI No.420
April 8, 2025	Desmopressin acetate hydrate (injections)	PRECAUTIONS [17.7 KB]	Summary of Investigation [84.7 KB]
	Imeglimin hydrochloride	PRECAUTIONS [42.2 KB]	Summary of Investigation [66.0 KB]
	Enzalutamide	PRECAUTIONS [20.8 KB]	Summary of Investigation [62.2 KB]
	Nirmatrelvir/ritonavir	PRECAUTIONS [24.7 KB]	Summary of Investigation [62.2 KB]

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