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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2020)

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 in Pharmaceuticals and Medical Devices Safety Information (PMDSI)
March 30,
2021
Magnesium sulfate hydrate/glucose (preparations indicated for prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) PRECAUTIONS
[69.59 KB]
Investigation
[244.47 KB]
-
Magnesium sulfate hydrate (preparations indicated for eclampsia) PRECAUTIONS
[230.85 KB]
Investigation
[244.47 KB]
-
Ritodrine hydrochloride (oral dosage form) PRECAUTIONS
[400.75 KB]
Investigation
[244.47 KB]
-
Ritodrine hydrochloride (injections) PRECAUTIONS
[253.83 KB]
Investigation
[244.47 KB]
PMDSI No. 382
Magnesium sulfate hydrate/glucose (preparations indicated for inhibition of uterine contractions in threatened premature labour, and prophylaxis and treatment of eclampsia in severe hypertensive disorders of pregnancy) PRECAUTIONS
[229.66 KB]
Investigation
[244.47 KB]
-
Cetuximab (genetical recombination) PRECAUTIONS
[216.16 KB]
Investigation
[212.89 KB]
-
Durvalumab (genetical recombination) PRECAUTIONS
[211.62 KB]
Investigation
[212.14 KB]
PMDSI No. 382
Iopamidol PRECAUTIONS
[223.37 KB]
Investigation
[225.42 KB]
-
February 25,
2021

March 30, 2021
Administrative Notice of Partial Correction
[139.43 KB]
Aspirin PRECAUTIONS
[219.29 KB]
Investigation
[415.27 KB]
-
Aspirin
Aspirin/dialuminate
PRECAUTIONS
[234.30 KB]
Investigation
[415.27 KB]
-
Ampiroxicam
Piroxicam
PRECAUTIONS
[232.99 KB]
Investigation
[415.27 KB]
-
Isopropylantipyrine PRECAUTIONS
[225.32 KB]
Investigation
[415.27 KB]
-
Pyrazolone-based antipyretics, analgesics and anti-inflammatory combination drug
Ethenzamide
PRECAUTIONS
[227.75 KB]
Investigation
[415.27 KB]
-
Ibuprofen
Celecoxib
Naproxen
Pranoprofen (oral agents)
Flurbiprofen axetil
Loxoprofen sodium hydrate
Lornoxicam
PRECAUTIONS
[233.81 KB]
Investigation
[415.27 KB]
-
Etodolac
Nabumetone
Flurbiprofen
Mefenamic acid
Mefenamic acid
Esflurbiprofen/mentha oil
PRECAUTIONS
[227.53 KB]
Investigation
[415.27 KB]
-
Ketoprofen PRECAUTIONS
[236.33 KB]
Investigation
[415.27 KB]
-
Ketoprofen PRECAUTIONS
[235.91 KB]
Investigation
[415.27 KB]
-
Zaltoprofen PRECAUTIONS
[233.02 KB]
Investigation
[415.27 KB]
-
Sodium salicylate/dibucaine combination drug
Sodium salicylate/dibucaine combination drug
Bucolome
Flufenamate aluminum
Mofezolac
PRECAUTIONS
[225.52 KB]
Investigation
[415.27 KB]
-
Sulpyrine hydrate PRECAUTIONS
[225.56 KB]
Investigation
[415.27 KB]
-
Tiaprofenic acid PRECAUTIONS
[226.05 KB]
Investigation
[415.27 KB]
-
Migrenin PRECAUTIONS
[225.26 KB]
Investigation
[415.27 KB]
-
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
PRECAUTIONS
[227.91 KB]

(corrected version)
Investigation
[415.27 KB]
-
Ibuprofen piconol
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Cataplasms/Gel Patches
Methyl salicylate/diphenhydramine combination drug
Methyl salicylate/glycyrrhetinic acid combination stick
Suprofen
PRECAUTIONS
[228.88 KB]
Investigation
[415.27 KB]
-
Indometacin (agents for epidermis)
Ketoprofen
Diclofenac sodium (agents for epidermis)
Piroxicam
Felbinac
Flurbiprofen
Loxoprofen sodium hydrate
Salicylic acid
Salicylic acid
Salicylic acid adhesive plaster
PRECAUTIONS
[229.13 KB]
Investigation
[415.27 KB]
-
Methyl salicylate PRECAUTIONS
[225.88 KB]
Investigation
[415.27 KB]
-
Adrenal extract and heparinoid combination drug PRECAUTIONS
[227.55 KB]
Investigation
[415.27 KB]
-
Aspirin
Aspirin/dialuminate
Aspirin/lansoprazole
Clopidogrel sulfate/aspirin
PRECAUTIONS
[237.38 KB]
Investigation
[415.27 KB]
-
Aspirin/vonoprazan fumarate PRECAUTIONS
[216.81 KB]
Investigation
[415.27 KB]
-
Salbutamol sulfate
Salbutamol sulfate
PRECAUTIONS
[229.40 KB]
Investigation
[213.06 KB]
PMDSI No. 381
January 26,
2021
Amiodarone hydrochloride (oral dosage form) PRECAUTIONS
[249.61 KB]
Investigation
[538.85 KB]

Appendix 4-1 and 4-2 are not included. See the Detailed information on revisions of PRECAUTIONS.
-
Sildenafil citrate (preparations indicated for pulmonary arterial hypertension) PRECAUTIONS
[221.56 KB]
Investigation
[538.85 KB]

Appendix 4-1 and 4-2 are not included. See the Detailed information on revisions of PRECAUTIONS.
-
January 26,
2021
Alemtuzumab (genetical recombination) PRECAUTIONS
[282.48 KB]
Investigation
[280.43 KB]
-
Pomalidomide PRECAUTIONS
[480.93 KB]
Investigation
[211.94 KB]
PMDSI No. 380
December 21,
2020
Lidocaine hydrochloride/adrenaline (excluding preparations for dental use) PRECAUTIONS
[225.63 KB]
Investigation
[428.65 KB]
-
Adrenaline (preparations indicated for prolonged action of local anaesthetics and for prevention and treatment of local haemorrhage during surgery) PRECAUTIONS
[226.83 KB]
Investigation
[428.65 KB]
-
December 8,
2020
Clopidogrel sulfate PRECAUTIONS
[229.26 KB]
Investigation
[226.94 KB]
-
Prasugrel hydrochloride PRECAUTIONS
[212.11 KB]
Investigation
[226.94 KB]
-
Venetoclax PRECAUTIONS
[238.07 KB]
Investigation
[243.65 KB]
-
Posaconazole
Posaconazole
PRECAUTIONS
[236.75 KB]
Investigation
[243.65 KB]
-
Eculizumab (genetical recombination) PRECAUTIONS
[228.25 KB]
Investigation
[226.98 KB]
-
November 5,
2020
Glatiramer acetate PRECAUTIONS
[232.62 KB]
Investigation
[211.15 KB]
-
Nivolumab (genetical recombination)
Nivolumab (genetical recombination)
PRECAUTIONS
[215.38 KB]
Investigation
[114.17 KB]
PMDSI No. 378
October 6,
2020
Vonoprazan fumarate PRECAUTIONS
[22.05 KB]
Investigation
[28.96 KB]
PMDSI No. 377
Vonoprazan fumarate/amoxicillin hydrate/clarithromycin
Vonoprazan fumarate/amoxicillin hydrate/metronidazole
PRECAUTIONS
[25.30 KB]
Investigation
[28.96 KB]
-
Cytarabine (excluding 400 mg and 1 g preparations) PRECAUTIONS
[25.48 KB]
Investigation
[26.86 KB]
-
Tazobactam/piperacillin hydrate PRECAUTIONS
[25.08 KB]
Investigation
[25.28 KB]
-
September 8,
2020
Ofloxacin (preparations for otic use) PRECAUTIONS
[55.11 KB]
Investigation
[381.48 KB]
-
Chloramphenicol (preparations for otic use)
Fosfomycin sodium (preparations for otic use)
Gentamicin sulfate (injections)
PRECAUTIONS
[50.96 KB]
Investigation
[381.48 KB]
-
Cefmenoxime hydrochloride (preparations for otic and nasal use)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Chloramphenicol sodium succinate (solution for topical use, oral dosage form)
Tetracycline hydrochloride (powders, capsules)
Tetracycline hydrochloride (powders, capsules)
Polymixin B sulfate (powders)
Clindamycin hydrochloride
Clindamycin phosphate (injections)
Benzylpenicillin potassium
Benzylpenicillin benzathine hydrate
Lincomycin hydrochloride hydrate
Lincomycin hydrochloride hydrate
Aztreonam
Amoxicillin hydrate
Ampicillin hydrate
Ampicillin sodium
Potassium clavulanate/amoxicillin hydrate
Dibekacin sulfate (injections)
Sultamicillin tosilate hydrate
Cefaclor
Cefazolin sodium
Cefazolin sodium hydrate
Cefalexin (oral dosage form with indications for otitis media)
Cephalothin sodium
Cefixime hydrate
Cefixime hydrate
Cefepime dihydrochloride hydrate
Cefozopran hydrochloride
Cefotiam hydrochloride (intravenous injections)
Cefcapene pivoxil hydrochloride hydrate
Cefditoren pivoxil
Cefdinir
Ceftazidime hydrate
Cefteram pivoxil
Ceftriaxone sodium hydrate
Cefpodoxime proxetil
Cefroxadine hydrate
Cefuroxime axetil
Tebipenem pivoxil
Doripenem hydrate
Bacampicillin hydrochloride
Panipenem/betamipron
Faropenem sodium hydrate
Flomoxef sodium
Fosfomycin calcium hydrate
Meropenem hydrate
Chloramphenicol sodium succinate
Demethylchlortetracycline hydrochloride
Doxycycline hydrochloride hydrate
Minocycline hydrochloride (oral dosage form)
Kanamycin sulfate
PRECAUTIONS
[61.70 KB]
Investigation
[381.48 KB]
-
Lomefloxacin hydrochloride (preparations for otic use)
Lomefloxacin hydrochloride (preparations for otic use)
PRECAUTIONS
[53.35 KB]
Investigation
[381.48 KB]
-
Azithromycin Hydrate (oral dosage form for pediatric use)
Erythromycin
Clarithromycin
Spiramycin acetate
Roxithromycin
Tosufloxacin tosilate hydrate (oral dosage form without dosage and administration for pediatric use)
Norfloxacin (oral dosage form with indications for otitis media)
PRECAUTIONS
[76.73 KB]
Investigation
[381.48 KB]
-
Erythromycin ethylsuccinate
Erythromycin stearate
Josamycin
Josamycin propionate
PRECAUTIONS
[40.53 KB]
Investigation
[381.48 KB]
-
Tosufloxacin tosilate hydrate (oral dosage form for pediatric use) PRECAUTIONS
[54.88 KB]
Investigation
[381.48 KB]
-
September 8,
2020
Relugolix PRECAUTIONS
[50.60 KB]
Investigation
[133.26 KB]
PMDSI No. 376
Hydroxychloroquine sulfate PRECAUTIONS
[49.96 KB]
Investigation
[145.34 KB]
-
July 20,
2020
Iodixanol
Iohexol (preparations with indications of cerebral angiography)
PRECAUTIONS
[56.50 KB]
Investigation
[63.24 KB]
-
Iopamidol
PRECAUTIONS
[56.55 KB]
Investigation
[63.24 KB]
PMDSI No. 375
Iopromide PRECAUTIONS
[57.23 KB]
Investigation
[63.24 KB]
-
Iohexol (preparations with indications of cerebral angiography, angiocardiography (including pulmonary artery angiography), aortography, and angiocardiography of pediatrics (including pulmonary artery angiography)) PRECAUTIONS
[57.61 KB]
Investigation
[63.24 KB]
-
Ioversol PRECAUTIONS
[56.96 KB]
Investigation
[63.24 KB]
-
Iomeprol PRECAUTIONS
[56.61 KB]
Investigation
[63.24 KB]
-
June 25,
2020
Oxytocin PRECAUTIONS
[77.30 KB]
Investigation
(only in Japanese)
[174.89 KB]
-
Dinoprost PRECAUTIONS
[37.37 KB]
Investigation
(only in Japanese)
[174.89 KB]
-
Dinoprostone (oral dosage form) PRECAUTIONS
[39.88 KB]
Investigation
(only in Japanese)
[174.89 KB]
-
Calonary L, Calonary M, Calonary H Infusion Solution
Hicaliq-1, Hicaliq-2, Hicaliq-3 Liquid
Hicaliq NC-L, Hicaliq NC-N, Hicaliq NC-H Infusion Solution
Rehabix-K1, Rehabix-K2 Infusion Solution
PRECAUTIONS
[26.86 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Amicaliq Infusion Solution
Paresafe Infusion Solution
Pareplus Infusion Solution
PRECAUTIONS
[25.90 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Amizet B Infusion Solution
Aminic Infusion Solution
Pleamin-P Injection, Hy-Pleamin Injection, Hy-Pleamin S Injection
Proteamin 12 Injection
Moriamin-S Injection
Moripron-F Infusion Solution
PRECAUTIONS
[26.94 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Amiparen Injection
Plas-amino Injection
PRECAUTIONS
[25.37 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Aminoleban Injection
Terufis Intravenous Drip Infusions
Hikarilevan Injection
PRECAUTIONS
[25.50 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Elneopa-NF No.1 Injection, Elneopa-NF No.2 Injection
Neoparen No.1 Injection, Neoparen No.2 Injection
Mixid L Injection, Mixid H Injection
PRECAUTIONS
[26.44 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Twinpal Infusion Solution
Bfluid Injection
PRECAUTIONS
[26.01 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Pntwin No.1, Pntwin No.2, Pntwin No.3 Infusion Solution
Fulcaliq 1, Fulcaliq 2, Fulcaliq 3 Infusion Solution
Onepal No.1, Onepal No.2 Infusion Solution
PRECAUTIONS
[26.62 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Morihepamin Intravenous Drip Infusions PRECAUTIONS
[25.22 KB]
Investigation
[170.83 KB]

The Appendix 3 is not included. See the Detailed information on revisions of PRECAUTIONS.
-
June 16,
2020
Memantine hydrochloride
Memantine hydrochloride
PRECAUTIONS
[53.49 KB]
Investigation
[154.23 KB]
PMDSI No. 374
Bevacizumab (genetical recombination)
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 1]
Bevacizumab (genetical recombination) [Bevacizumab biosimilar 2]
PRECAUTIONS
[52.01 KB]
Investigation
[162.60 KB]
-
June 1,
2020
Selexipag PRECAUTIONS
[84.82 KB]
Investigation
[533.47 KB]

The Appendix for draft revisions is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Clopidogrel sulfate PRECAUTIONS
[76.55 KB]
Investigation
[533.47 KB]

The Appendix for draft revisions is not included. See the Detailed information on revisions of PRECAUTIONS.
-
Clopidogrel sulfate/aspirin PRECAUTIONS
[62.03 KB]
Investigation
[533.47 KB]

The Appendix for draft revisions is not included. See the Detailed information on revisions of PRECAUTIONS.
-
May 19,
2020
Insulin human (genetical recombination)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
PRECAUTIONS
[85.01 KB]
Investigation
[198.24 KB]

Investigation
(only in Japanese)
[532.54 KB]
-
Insulin aspart (genetical recombination) PRECAUTIONS
[82.99 KB]
Investigation
[198.24 KB]

Investigation
(only in Japanese)
[532.54 KB]
-
Insulin glulisine (genetical recombination) PRECAUTIONS
[76.35 KB]
Investigation
[198.24 KB]

Investigation
(only in Japanese)
[532.54 KB]
-
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1]
PRECAUTIONS
[85.80 KB]
Investigation
[198.24 KB]

Investigation
(only in Japanese)
[532.54 KB]
-
Insulin human (genetical recombination)
Insulin human (genetical recombination)
Insulin aspart (genetical recombination)
Insulin glargine (genetical recombination)
Insulin detemir (genetical recombination)
Insulin glulisine (genetical recombination)
Insulin degludec (genetical recombination)
Insulin glargine (genetical recombination) [Insulin glargine biosimilar 1]
Insulin glargine (genetical recombination) [Insulin glargine biosimilar 2]
Insulin degludec (genetical recombination)/insulin aspart (genetical recombination)
PRECAUTIONS
[76.77 KB]
Investigation
[181.59 KB]
-
Insulin lispro (genetical recombination)
Insulin lispro (genetical recombination)
Insulin lispro mix preparation 25
Insulin lispro mix preparation 50
Insulin degludec (genetical recombination)/liraglutide (genetical recombination)
Insulin glargine (genetical recombination)/lixisenatide
Insulin lispro (genetical recombination) [Insulin lispro biosimilar 1]
PRECAUTIONS
[72.76 KB]
Investigation
[181.59 KB]
-
Apalutamide PRECAUTIONS
[71.42 KB]
Investigation
[155.25 KB]
PMDSI No. 373
Fulvestrant PRECAUTIONS
[67.67 KB]
Investigation
[152.13 KB]
-