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Post-marketing Safety Measures

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.
-
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.
-
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]
-
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]
- -
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.
-
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.
-