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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2024)

Date Nonproprietary name
(Click on each drug name for more information
[only in Japanese])
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)
January 29, 2025 PRECAUTIONS
[14.3 KB]
Summary of
Investigation
[95.2 KB]
-
PRECAUTIONS
[14.8 KB]
Summary of
Investigation
[95.2 KB]
-
PRECAUTIONS
[14.0 KB]
Summary of
Investigation
[95.2 KB]
-
PRECAUTIONS
[89.0 KB]
Summary of
Investigation
[80.7 KB]
-
PRECAUTIONS
[13.0 KB]
Summary of
Investigation
[29.7 KB]
-
December 17, 2024 PRECAUTIONS
[31.1 KB]
Report on
Investigation
[134 KB]

Appendix 3 is not included in this file. See PRECAUTIONS.
-
PRECAUTIONS
[75.8 KB]
Report on
Investigation
[134 KB]

Appendix 3 is not included in this file. See PRECAUTIONS.
-
PRECAUTIONS
[14.7 KB]
Summary of
Investigation
[166 KB]
PMDSI No.416
PRECAUTIONS
[25.6 KB]
Summary of
Investigation
[37.2 KB]
PMDSI No.416
PRECAUTIONS
[22.0 KB]

PRECAUTIONS
[22.0 KB]
Summary of
Investigation
[48.3 KB]
-
PRECAUTIONS
[139 KB]

PRECAUTIONS
[21.5 KB]

PRECAUTIONS
[20.7 KB]
Summary of
Investigation
[48.3 KB]
-
  • Potassium iodide
    (preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
  • Potassium iodide
    (preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
PRECAUTIONS
[30.7 KB]
Report on
Investigation
[134 KB]

Appendix 3 is not included in this file. See PRECAUTIONS.
-
  • Potassium iodide
    (preparations indicated for prevention/reduction of internal exposure of the thyroid gland to radioactive iodine)
PRECAUTIONS
[26.3 KB]
Report on
Investigation
[134 KB]

Appendix 3 is not included in this file. See PRECAUTIONS.
-
PRECAUTIONS
[14.3 KB]
Summary of
Investigation
[166 KB]
PMDSI No.416
PRECAUTIONS
[14.3 KB]
Summary of
Investigation
[166 KB]
PMDSI No.416
PRECAUTIONS
[14.5 KB]
Summary of
Investigation
[166 KB]
PMDSI No.416
PRECAUTIONS
[13.6 KB]
Summary of
Investigation
[35.0 KB]
PMDSI No.416
PRECAUTIONS
[14.4 KB]
Summary of
Investigation
[32.7 KB]
PMDSI No.416
PRECAUTIONS
[18.6 KB]
(References) Material for the 2024 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs Council (the 9th meeting) (only in Japanese) -
PRECAUTIONS
[18.7 KB]
(References) Material for the 2024 Subcommittee on Drug Safety of the Committee on Drug Safety in the Pharmaceutical Affairs Council (the 9th meeting) (only in Japanese) -
November 13, 2024 PRECAUTIONS
[13.7 KB]
Summary of
Investigation
[26.2 KB]
-
PRECAUTIONS
[14.6 KB]
Summary of
Investigation
[30.4 KB]
PMDSI No.415

PRECAUTIONS
[13.4 KB]

Summary of
Investigation
[25.4 KB]
-
PRECAUTIONS
[21.9 KB]
Summary of
Investigation
[26.7 KB]
-
PRECAUTIONS
[21.6 KB]
Summary of
Investigation
[26.7 KB]
-
PRECAUTIONS
[14.5 KB]
Summary of
Investigation
[26.7 KB]
-
PRECAUTIONS
[13.4 KB]
Summary of
Investigation
[85.0 KB]
-
PRECAUTIONS
[14.0 KB]
Summary of
Investigation
[42.6 KB]
-
  • Ethyl icosapentate (OTC drug)
PRECAUTIONS
[14.4 KB]
Summary of
Investigation
[23.5 KB]
-
October 8, 2024
  • Aspirin
    (preparations
    indicated for
    antipyresis/analgesia/
    anti-inflammation)
PRECAUTIONS [71.5 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [93.4 KB] Summary of
Investigation 1
[122 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [96.9 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [74.2 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [73.3 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [75.5 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [96.1 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [73.6 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [73.3 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [75.0 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [96.2 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [73.7 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [73.1 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [96.4 KB] Summary of
Investigation 1
[122 KB]


Summary of
Investigation 2
[182 KB]


(Appendix)
[1,395 KB]

Summary of
the NDB study
-
PRECAUTIONS [73.1 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [73.5 KB] Summary of
Investigation 2
[182 KB]
-
PRECAUTIONS [72.7 KB] Summary of
Investigation 2
[182 KB]
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  • Preparations containing ibuprofen (OTC drugs)
  • Preparations containing naproxen (guidance-mandatory drugs)
  • Preparations containing loxoprofen sodium hydrate (oral dosage form) (guidance-mandatory drugs, OTC drugs)
PRECAUTIONS
[70.4 KB]
Summary of
Investigation 3
[93.2 KB]
-
August 27, 2024 PRECAUTIONS
[31.8 KB]
Summary of
Investigation
[56.2 KB]
-
PRECAUTIONS
[20.3 KB]
Summary of
Investigation
[33.1 KB]


(Appendix 1)
[225 KB]

Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET)

(Appendix 2)
[216 KB]

Evaluation of the risk of kidney function test abnormal in patients with mirogabalin besilate using MID-NET
PMDSI No.413
PRECAUTIONS
[107 KB]
Summary of
Investigation
[148KB]
-
PRECAUTIONS
[96.9 KB]
Summary of
Investigation
[148KB]
-
PRECAUTIONS
[15.5 KB]
Summary of
Investigation
[148KB]
-
PRECAUTIONS
[15.8 KB]
Summary of
Investigation
[148KB]
-
PRECAUTIONS
[13.0 KB]
Summary of
Investigation
[31.8 KB]
PMDSI No.413
PRECAUTIONS
[14.2 KB]
Summary of
lnvestigation
[32.5 KB]
PMDSI No.413
PRECAUTIONS
[13.0 KB]
Summary of
Investigation
[31.7 KB]
-
  • Preparations containing sulfamethoxazole sodium (OTC antibacterial ophthalmic solution)
  • Preparations containing sulfamethoxazole (OTC antibacterial ophthalmic solution)
PRECAUTIONS
[16.1 KB]
Summary of
Investigation
[112 KB]
PMDSI No.413
July 17, 2024 PRECAUTIONS
[25.7 KB]
Summary of
Investigation
[128 KB]
PMDSI No.412
PRECAUTIONS
[95.2 KB]
Summary of
Investigation
[114 KB]
-
PRECAUTIONS
[98.6 KB]
Summary of
Investigation
[30.9 KB]
-
PRECAUTIONS
[89.8 KB]
Summary of
Investigation
[125 KB]
PMDSI No.412
PRECAUTIONS
[123 KB]
Summary of
Investigation
[107 KB]
PMDSI No.412
PRECAUTIONS
[105 KB]
Summary of
Investigation
[115 KB]
-
PRECAUTIONS
[94.4 KB]
Summary of
Investigation
[35.0 KB]
PMDSI No.412
July 4, 2024 PRECAUTIONS
[127 KB]
- -
June 11, 2024 PRECAUTIONS
[14.5 KB]
Summary of
Investigation
[115 KB]
PMDSI No.411
PRECAUTIONS
[14.4 KB]
Summary of
Investigation
[115 KB]
-
PRECAUTIONS
[17.9 KB]
Summary of
Investigation
[121 KB]
-
PRECAUTIONS
[14.9 KB]
Summary of
Investigation
[121 KB]
-
PRECAUTIONS
[17.5 KB]
Summary of
Investigation
[121 KB]
-
PRECAUTIONS
[14.9 KB]
Summary of
Investigation
[27.4 KB]
-
May 17,
2024
PRECAUTIONS
[34.37 KB]
- -
May 8, 2024 PRECAUTIONS [116 KB] Summary of
Investigation
[121 KB]
-
PRECAUTIONS [108 KB] Summary of
Investigation
[162 KB]
-
PRECAUTIONS [112 KB] Summary of
Investigation
[142 KB]
-
PRECAUTIONS [119 KB] Summary of
Investigation
[121 KB]
-
PRECAUTIONS [117 KB] Summary of
Investigation
[142 KB]
-
April 9, 2024 PRECAUTIONS [152 KB] Report on
Investigation
[248 KB]

Appendix 4 is not included in this file. See PRECAUTIONS.
-
PRECAUTIONS [153 KB] Report on
Investigation
[248 KB]

Appendix 4 is not included in this file. See PRECAUTIONS.
-
PRECAUTIONS [149 KB] Report on
Investigation
[236 KB]

Appendix 4 is not included in this file. See PRECAUTIONS.
-