Revisions of PRECAUTIONS (FY2022)

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 (Important Safety Information) in Pharmaceuticals and Medical Devices Safety Information (PMDSI)
March 27, 2023	Anti-human thymocyte immunoglobulin, rabbit	PRECAUTIONS [109.76 KB]	-	-
March 23, 2023	Borofalan (¹⁰B)	PRECAUTIONS [26.26 KB]	Investigation [48.98 KB]	PMDSI 400
	Enviomycin sulfate Cycloserine Aluminoparaaminosalicylate calcium hydrate Isoniazid Isoniazid Isoniazid sodium methanesulfonate hydrate Ethionamide Calcium paraaminosalicylate hydrate Pyrazinamide Bedaquiline fumarate	PRECAUTIONS [32.79 KB]	Investigation [70.89 KB]	-
	Kanamycin sulfate Streptomycin sulfate	PRECAUTIONS [30.23 KB]	Investigation [70.89 KB]	-
	Rifabutin	PRECAUTIONS [27.44 KB]	Investigation [70.89 KB]	-
	Rifampicin Ethambutol hydrochloride Levofloxacin hydrate (oral dosage form)	PRECAUTIONS [30.94 KB]	Investigation [70.89 KB]	-
	Delamanid	PRECAUTIONS [27.17 KB]	Investigation [70.89 KB]	-
February 14, 2023	Exenatide Semaglutide (genetical recombination) Semaglutide (genetical recombination) Dulaglutide (genetical recombination) Lixisenatide Liraglutide (genetical recombination) Insulin glargine (genetical recombination)/lixisenatide Insulin degludec (genetical recombination)/liraglutide (genetical recombination)	PRECAUTIONS [29.30 KB]	Investigation [89.78 KB]	PMDSI 399
	Tirzepatide	PRECAUTIONS [27.23 KB]	Investigation [89.78 KB]	PMDSI 399
	Tazobactam/piperacillin hydrate	PRECAUTIONS [75.25 KB]	Investigation [32.56 KB]	PMDSI 399
January 17, 2023 February 10, 2023 Administrative Notice of Partial Correction [71.46 KB]	Acetaminophen (oral dosage form) Acetaminophen (oral dosage form) Acetaminophen (suppositories) Tramadol hydrochloride/ acetaminophen Non-pyrine common cold medicine Non-pyrine common cold medicine Non-pyrine common cold medicine Non-pyrine common cold medicine Non-pyrine common cold medicine Diprophylline/ dihydrocodeine phosphate/ dl-methylephedrine hydrochloride/ diphenhydramine salicylate/ acetaminophen/ bromovalerylurea	PRECAUTIONS [70.24 KB]	Investigation [187.55 KB]	PMDSI 398
	Acetaminophen (injections) Pyrazolone-based antipyretics, analgesics and anti-inflammatory combination drug	PRECAUTIONS [27.39 KB]	Investigation [187.55 KB]	PMDSI 398
	Clopidogrel sulfate Clopidogrel sulfate/aspirin	PRECAUTIONS [32.79 KB]	Investigation [121.48 KB]	PMDSI 398
	Alendronate sodium hydrate Alendronate sodium hydrate	PRECAUTIONS [123.40 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Ibandronate sodium hydrate Ibandronate sodium hydrate	PRECAUTIONS [118.12 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Etidronate disodium	PRECAUTIONS [117.74 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Zoledronic acid hydrate (preparations indicated for osteoporosis)	PRECAUTIONS [118.28 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Minodronic acid hydrate	PRECAUTIONS [124.21 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Sodium risedronate hydrate	PRECAUTIONS [124.37 KB]	Investigation [147.31 KB] Appendix: Database study using MID-NET on risk assessment of hypocalcaemia in patients with renal impairment prescribed bisphosphonate preparations [186.16 KB]	-
	Hydroxychloroquine sulfate	PRECAUTIONS [26.70 KB]	Investigation [113.42 KB]	-
	Imatinib mesilate	PRECAUTIONS [27.83 KB]	Investigation [118.04 KB]	-
	Oral live attenuated human rotavirus vaccine	PRECAUTIONS [26.10 KB]	Investigation [27.09 KB]	PMDSI 398
	Preparations containing acetaminophen (oral dosage form) (OTC drugs) Acetaminophen (suppositories) (OTC drugs)	PRECAUTIONS [27.86 KB] (corrected version)	Investigation [111.70 KB]	PMDSI 398
January 12, 2023	Hydroxyethylated starch 70000 Hydroxyethylated starch 70000/sodium chloride/potassium chloride/calcium chloride hydrate/sodium lactate	PRECAUTIONS [30.82 KB]	Investigation [939.45 KB] Appendix 7 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
January 12, 2023	Hydroxyethylated starch 130000	PRECAUTIONS [38.75 KB]	Investigation [939.45 KB] Appendix 7 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
December 5, 2022	Amlodipine besilate	PRECAUTIONS [31.00 KB]	Investigation [96.54 KB] Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
December 5, 2022	Nifedipine	PRECAUTIONS [83.58 KB]	Investigation [239.74 KB] Appendix 4 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
November 16, 2022	Hydrochlorothiazide	PRECAUTIONS [123.45 KB]	Investigation [29.38 KB]	PMDSI 397
	Candesartan cilexetil/ hydrochlorothiazide Valsartan/ hydrochlorothiazide	PRECAUTIONS [125.62 KB]	Investigation [29.38 KB]	PMDSI 397
	Losartan potassium/ hydrochlorothiazide	PRECAUTIONS [31.13 KB]	Investigation [29.38 KB]	PMDSI 397
	Roxadustat	PRECAUTIONS [117.39 KB]	Investigation [119.43 KB]	PMDSI 397
	Imatinib mesilate	PRECAUTIONS [117.97 KB]	Investigation [115.23 KB]	PMDSI 397
	Amoxicillin hydrate	PRECAUTIONS [160.85 KB]	Investigation [118.77 KB]	-
	Potassium clavulanate/amoxicillin hydrate	PRECAUTIONS [148.73 KB]	Investigation [118.77 KB]	-
	Vonoprazan fumarate/amoxicillin hydrate/clarithromycin Vonoprazan fumarate/amoxicillin hydrate/metronidazole	PRECAUTIONS [163.33 KB]	Investigation [118.77 KB]	-
	Rabeprazole sodium/amoxicillin hydrate/clarithromycin	PRECAUTIONS [164.26 KB]	Investigation [118.77 KB]	-
	Rabeprazole sodium/amoxicillin hydrate/metronidazole	PRECAUTIONS [147.62 KB]	Investigation [118.77 KB]	-
October 20, 2022	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.1), Comirnaty RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5)) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Spikevax Intramuscular Injection (Bivalent: Original/Omicron BA.1))	PRECAUTIONS [28.73 KB]	-	-
	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection (Monovalent: Original))	PRECAUTIONS [29.36 KB]	-	-
	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Spikevax Intramuscular Injection (Monovalent: Original))	PRECAUTIONS [29.30 KB]	-	-
October 12, 2022	Pemafibrate	PRECAUTIONS [74.66 KB]	Investigation [23.97 KB] (References) Material for the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 13th meeting) (Only in Japanese)	-
October 12, 2022	Loxoprofen sodium hydrate (oral dosage form) (prescription drug)	PRECAUTIONS [72.35 KB]	Investigation [35.34 KB]	-
	Methotrexate Methotrexate Methotrexate Methotrexate	PRECAUTIONS [74.28 KB]	Investigation [40.87 KB]	PMDSI 396
	Ipilimumab (genetical recombination)	PRECAUTIONS [26.68 KB]	Investigation [126.42 KB]	-
	Nivolumab (genetical recombination)	PRECAUTIONS [26.75 KB]	Investigation [126.42 KB]	-
	Pembrolizumab (genetical recombination)	PRECAUTIONS [26.02 KB]	Investigation [126.42 KB]	-
	Itraconazole (tablets, capsules)	PRECAUTIONS [74.12 KB]	Investigation [35.34 KB]	-
	Itraconazole (oral solution)	PRECAUTIONS [73.94 KB]	Investigation [35.34 KB]	-
	Itraconazole (injections)	PRECAUTIONS [70.71 KB]	Investigation [35.34 KB]	-
	Preparations containing loxoprofen sodium hydrate (oral dosage form) (OTC drugs)	PRECAUTIONS [28.84 KB]	Investigation [113.07 KB]	-
September 13, 2022	Riociguat	PRECAUTIONS [34.25 KB]	Investigation [244.52 KB]	-
	Atazanavir sulfate	PRECAUTIONS [77.75 KB]	Investigation [244.52 KB]	-
	Ritonavir	PRECAUTIONS [33.82 KB]	Investigation [244.52 KB]	-
	Lopinavir/ritonavir	PRECAUTIONS [33.19 KB]	Investigation [244.52 KB]	-
August 30, 2022	Hydroxychloroquine sulfate	PRECAUTIONS [39.25 KB]	Investigation [26.65 KB]	-
August 30, 2022	Ramucirumab (genetical recombination)	PRECAUTIONS [24.77 KB]	Investigation [25.66 KB]	PMDSI 395
July 20, 2022	Eszopiclone	PRECAUTIONS [233.01 KB]	Investigation [244.52 KB]	-
	Zopiclone	PRECAUTIONS [210.65 KB]	Investigation [244.52 KB]	-
	Zolpidem tartrate	PRECAUTIONS [229.39 KB]	Investigation [244.52 KB]	-
	Triazolam	PRECAUTIONS [153.33 KB]	Investigation [244.52 KB]	-
	Triazolam	PRECAUTIONS [153.33 KB]	Investigation [225.47 KB]	-
	Avelumab (genetical recombination) Durvalumab (genetical recombination)	PRECAUTIONS [210.49 KB]	Investigation [217.16 KB]	PMDSI 394 PMDSI 394
	Bortezomib	PRECAUTIONS [229.95 KB]	Investigation [215.16 KB]	-
	Posaconazole Posaconazole	PRECAUTIONS [219.01 KB]	Investigation [225.47 KB]	-
	Iopamidol Iohexol	PRECAUTIONS [229.51 KB]	Investigation [337.43 KB]	-
	Iomeprol	PRECAUTIONS [210.65 KB]	Investigation [337.43 KB]	-
July 8, 2022	Recombinant COVID-19 (SARS-CoV-2) vaccine (Nuvaxovid Intramuscular Injection)	PRECAUTIONS [27.29 KB]	Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 81st meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 6th meeting) (joint meeting) (Only in Japanese)	-
June 14, 2022	Cetuximab sarotalocan sodium (genetical recombination)	PRECAUTIONS [228.15 KB]	Investigation [214.83 KB]	PMDSI 393
	Nivolumab (genetical recombination) Pembrolizumab (genetical recombination)	PRECAUTIONS [214.03 KB]	Investigation [103.03 KB]	-
	Vonoprazan fumarate/amoxicillin hydrate/metronidazole Rabeprazole sodium/amoxicillin hydrate/metronidazole	PRECAUTIONS [234.88 KB]	Investigation [346.19 KB]	-
	Nirmatrelvir/ritonavir	PRECAUTIONS [211.46 KB]	Investigation [214.83 KB]	PMDSI 393
	Molnupiravir	PRECAUTIONS [211.57 KB]	Investigation [215.33 KB]	PMDSI 393
	Metronidazole (oral dosage form)	PRECAUTIONS [214.41 KB]	Investigation [346.19 KB]	-
	Metronidazole (injections)	PRECAUTIONS [214.19 KB]	Investigation [346.19 KB]	-
June 10, 2022	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection for 5 to 11 years old) Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection))	PRECAUTIONS [29.18 KB]	Material for the Side Effect Subcommittee of the Immunization and Vaccine Section Meeting in the Health Science Council (the 80th meeting), and the 2022 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs and Food Sanitation Council (the 5th meeting) (joint meeting) (Only in Japanese)	-
May 13, 2022	Dexamethasone (oral dosage form) (preparations indicated for pituitary suppression tests)	PRECAUTIONS [242.04 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Dexamethasone (oral dosage form) (preparations not indicated for pituitary suppression tests) Dexamethasone palmitate	PRECAUTIONS [217.61 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Dexamethasone sodium phosphate (injections)	PRECAUTIONS [237.97 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Betamethasone (oral dosage form)	PRECAUTIONS [240.13 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Betamethasone (suppositories) Betamethasone acetate/betamethasone sodium phosphate Betamethasone sodium phosphate (enemas)	PRECAUTIONS [229.99 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Betamethasone/ d-chlorpheniramine maleate Betamethasone sodium phosphate (injections)	PRECAUTIONS [236.71 KB]	Investigation [1,002.19 KB]	PMDSI 392
	Teicoplanin	PRECAUTIONS [219.63 KB]	Investigation [291.03 KB]	-
April 26, 2022	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Comirnaty intramuscular injection)	PRECAUTIONS [212.74 KB]	-	-
April 26, 2022	Coronavirus modified uridine RNA vaccine (SARS-CoV-2) (Spikevax Intrammuscular Injection (former brand name: COVID-19 Vaccine Moderna Intramuscular Injection))	PRECAUTIONS [214.09 KB]	-	-
April 4, 2022	Interferon beta-1a (genetical recombination)	PRECAUTIONS [211.23 KB]	Investigation [435.72 KB] Appendix 5 and 6 are not included. See the Detailed information on revisions of PRECAUTIONS.	-
April 4, 2022	Interferon beta-1b (genetical recombination)	PRECAUTIONS [211.29 KB]	Investigation [435.72 KB] Appendix 5 and 6 are not included. See the Detailed information on revisions of PRECAUTIONS.	-
April 4, 2022	Somatropin (genetical recombination)	PRECAUTIONS [263.72 KB]	Investigation [926.56 KB] Appendix 5 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
	Somatropin (genetical recombination)	PRECAUTIONS [274.18 KB]	Investigation [926.56 KB] Appendix 5 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
	Somatropin (genetical recombination)	PRECAUTIONS [263.22 KB]	Investigation [926.56 KB] Appendix 5 is not included. See the Detailed information on revisions of PRECAUTIONS.	-
	Somatropin (genetical recombination)	PRECAUTIONS [270.58 KB]	Investigation [926.56 KB] Appendix 5 is not included. See the Detailed information on revisions of PRECAUTIONS.	-