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Post-marketing Safety Measures

Revisions of PRECAUTIONS (FY2017)

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)
March 27,
 2018
Propofol
Propofol
Propofol
Propofol
PRECAUTIONS
[99.08 KB]
Investigation
[426.57 KB]
Adrenaline (preparations indicated for
emergency supplemental treatment of
anaphylactic reactions caused by
allergens in vespid venom, food, drugs
and other allergens)
PRECAUTIONS
[111.72 KB]
Investigation
[210.30 KB]
Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions)

Adrenaline (preparations indicated for
emergency supplemental treatment of
acute hypotension or shock associated
with various diseases or conditions)
PRECAUTIONS
[114.03 KB]
Investigation
[210.30 KB]
Asenapine maleate
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
aripiprazole
olanzapine
olanzapine
olanzapine
olanzapine
quetiapine fumarate
quetiapine fumarate
quetiapine fumarate
clocapramine hydrochloride hydrate
clocapramine hydrochloride hydrate
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine hydrochloride
chlorpromazine
hydrochloride/promethazine
hydrochloride/phenobarbital

chlorpromazine phenolphthalinate
spiperone
zotepine
timiperone
timiperone
haloperidol
haloperidol
haloperidol
haloperidol
paliperidone
pipamperone
hydrochloride

fluphenazine decanoate
fluphenazine maleate
brexpiprazole
prochlorperazine mesilate
prochlorperazine maleate
propericiazine
bromperidol
perphenazine
perphenazine
hydrochloride

perphenazine fendizoate
perphenazine maleate
perospirone
hydrochloride hydrate

mosapramine hydrochloride
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
risperidone (oral drug)
levomepromazine hydrochloride
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate
levomepromazine maleate
PRECAUTIONS
[67.44 KB]
Investigation
[210.30 KB]
Aripiprazole hydrate
Aripiprazole hydrate
Paliperidone palmitate
Haloperidol decanoate
Risperidone (injections)
PRECAUTIONS
[46.59 KB]
Investigation
[210.30 KB]
Clozapine PRECAUTIONS
[46.03 KB]
Investigation
[210.30 KB]
Blonanserin PRECAUTIONS
[46.42 KB]
Investigation
[210.30 KB]
March 27,
 2018
Azithromycin hydrate (Tablets 250 mg/500 mg)
Azithromycin hydrate (Dry syrup)
Azithromycin hydrate (For pediatric use)
Azithromycin hydrate (For pediatric use)
Aztreonam
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin
Hydrate/potassium clavulanate

Amoxicillin
Hydrate/potassium clavulanate

Ampicillin Hydrate
Ampicillin Hydrate
Ampicillin Sodium
Ampicillin Sodium, Cloxacillin Sodium Hydrate (100mg preparation)
Imipenem Hydrate, Cilastatin Sodium
Imipenem Hydrate, Cilastatin Sodium
Erythromycin
Erythromycin Ethylsuccinate
Erythromycin Ethylsuccinate
Erythromycin Stearate
Ofloxacin (Tablets)
Kanamycin Monosulfate
Kanamycin Monosulfate
Kanamycin Sulfate
Clarithromycin
Clarithromycin
Clarithromycin
Clindamycin Hydrochloride
Clindamycin Phosphate (For injection)
Clindamycin Phosphate (For injection)
Chloramphenicol(For topical application)
Chloramphenicol(For oral use)
Chloramphenicol Sodium Succinate
Colistin Sodium Methanesulfonate
Colistin Sodium Methanesulfonate
Sitafloxacin Hydrate
Sitafloxacin Hydrate
Ciprofloxacin Hydrochloride Hydrate
Dibekacin Sulfate (For injection)
Dibekacin Sulfate (For injection)
Josamycin
Josamycin Propionate
Josamycin Propionate
Spiramycin Acetate
Sultamicillin Tosilate Hydrate
Sultamicillin Tosilate Hydrate
Sulfamethoxazole,Trimethoprim (For oral use)
Cefaclor
Cefaclor
Cefaclor
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefazolin Sodium Hydrate
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalexin
Cefalotin Sodium
Cefixime Hydrate
Cefepime Dihydrochloride Hydrate
Cefepime Dihydrochloride Hydrate
Cefozopran Hydrochloride
Cefotaxime Sodium
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hydrochloride
Cefotiam Hexetil Hydrochloride
Cefoperazone Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefoperazone Sodium, Sulbactam Sodium
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefcapene Pivoxil Hydrochloride Hydrate
Cefditoren Pivoxil
Cefditoren Pivoxil
Cefdinir
Cefdinir
Cefdinir
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftazidime Hydrate
Ceftizoxime Sodium
Ceftibuten Hydrate
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Cefteram Pivoxil
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Ceftriaxone Sodium Hydrate
Cefpirome Sulfate
Cefpodoxime Proxetil
Cefpodoxime Proxetil
Cefminox Sodium Hydrate
Cefmetazole Sodium
Cefmetazole Sodium
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For injection)
Cefmenoxime Hydrochloride (For ear and nose)
Cefroxadine Hydrate
Cefuroxime Axetil
Tetracycline Hydrochloride (For oral use)
Tetracycline Hydrochloride (For oral use)
Tebipenem Pivoxil
Demethylchlortetracycline Hydrochloride
Doxycycline Hydrochloride Hydrate
Tosufloxacin Tosilate Hydrate (Tablets)
Tosufloxacin Tosilate Hydrate (Tablets)
Tobramycin
Doripenem Hydrate
Nalidixic acid
Nalidixic acid
Norfloxacin (Tablets)
Norfloxacin (Tablets)
Bacampicillin Hydrochloride
Panipenem, Betamipron
Vancomycin Hydrochloride (Powder)
Pipemidic Acid Hydrate
Piperacillin Sodium
Piperacillin Sodium
Piperacillin Sodium
Faropenem Sodium Hydrate
Faropenem Sodium Hydrate
Prulifloxacin
Flomoxef Sodium
Benzylpenicillin Potassium
Benzylpenicillin Benzathine Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Calcium Hydrate
Fosfomycin Sodium (For injection)
Fosfomycin Sodium (For injection)
Polymixin B Sulfate (Powder)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For oral use)
Minocycline Hydrochloride (For injection)
Garenoxacin Mesilate Hydrate
Metronidazole (For oral use)
Metronidazole (For injection)
Meropenem Hydrate
Moxifloxacin hydrochloride (Tablets)
Latamoxef Sodium
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Lincomycin Hydrochloride Hydrate
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Levofloxacin Hydrate (For oral use)
Roxithromycin
Lomefloxacin hydrochloride (For oral use)
PRECAUTIONS
[113.58 KB]
Investigation
[839.40 KB]
March 20,
 2018
Tolvaptan PRECAUTIONS
[100.89 KB]
Investigation
[116.58 KB]
Selexipag PRECAUTIONS
[44.53 KB]
Investigation
[133.38 KB]
Clopidogrel sulfate
Clopidogrel sulfate/aspirin
PRECAUTIONS
[44.68 KB]
Investigation
[133.38 KB]
Anagliptin PRECAUTIONS
[57.35 KB]
Investigation
[96.55 KB]
Anagliptin PRECAUTIONS
[57.35 KB]
Investigation
[107.46 KB]
Linagliptin

Teneligliptin hydrobromide hydrate

Teneligliptin hydrobromide hydrate/canagliflozin hydrate
PRECAUTIONS
[56.76 KB]
Investigation
[107.46 KB]
Sterile talc PRECAUTIONS
[44.88 KB]
Investigation
[97.00 KB]
February 13,
 2018
Gardenia fruit
Gardenia fruit
Gardenia fruit
Gardenia fruit
PRECAUTIONS
[115.02 KB]
Investigation
[154.30 KB]
Inchinkoto extract
Inchinkoto extract
Inchinkoto extract 

Orengedokuto extract
Orengedokuto extract
Orengedokuto extract
Orengedokuto extract

Kamishoyosan extract
Kamishoyosan extract
Kamishoyosan extract

Shiniseihaito extract
Shiniseihaito extract
PRECAUTIONS
[46.49 KB]
Investigation
[154.30 KB]
PRECAUTIONS
[57.42 KB]
Investigation
[154.30 KB]
Efavirenz PRECAUTIONS
[43.60 KB]
Investigation
[98.06 KB]
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel)
Iohexol (for urinary tract, blood vessel, CT)
Iohexol (for urinary tract, blood vessel, CT)
PRECAUTIONS
[45.51 KB]
Investigation
[145.17 KB]
Iomeprol
Iomeprol
PRECAUTIONS
[45.65 KB]
Investigation
[145.17 KB]
Products containing gardenia fruit
 (OTC drugs)
PRECAUTIONS
[46.47 KB]
Investigation
[170.83 KB]
January 11,
 2018
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole
Aripiprazole

Aripiprazole hydrate
Aripiprazole hydrate
PRECAUTIONS
[44.96 KB]
Investigation
[117.45 KB]
Teriparatide
 (genetical recombination)
PRECAUTIONS
[59.76 KB]
Investigation
[106.95 KB]
Teriparatide acetate
Teriparatide acetate
PRECAUTIONS
[116.82 KB]
Investigation
[106.95 KB]
Edoxaban tosilate hydrate
Edoxaban tosilate hydrate
PRECAUTIONS
[44.82 KB]
Investigation
[106.59 KB]
Ipilimumab
 (genetical recombination)
PRECAUTIONS
[44.34 KB]
Investigation
[89.59 KB]
Lenvatinib mesilate PRECAUTIONS
[45.29 KB]
Investigation
[87.75 KB]
November 28,
2017
Clozapine PRECAUTIONS
[45.30 KB]
Investigation
[28.87 KB]
Gadoxetate sodium
Gadoteridol
Meglumine gadoterate
Gadobutrol
PRECAUTIONS
[46.86 KB]
Investigation
[953.34 KB]
Gadodiamide hydrate
Gadodiamide hydrate

Meglumine gadopentetate
Meglumine gadopentetate
PRECAUTIONS
[49.40 KB]
Investigation
[953.34 KB]
October 17,
 2017
Levetiracetam
Levetiracetam
Levetiracetam
PRECAUTIONS
[44.60 KB]
Investigation
[109.18 KB]
Chlorhexidine hydrochloride/
diphenhydramine salicylate/
hydrocortisone acetate/
benzalkonium chloride concentrated solution 50
PRECAUTIONS
[47.84 KB]
Investigation
[120.17 KB]
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
Chlorhexidine gluconate
PRECAUTIONS
[47.87 KB]
Investigation
[120.17 KB]
Products containing chlorhexidine gluconate or products containing chlorhexidine hydrochloride (OTC drugs) PRECAUTIONS
[57.91 KB]
Investigation
[30.84 KB]
Linagliptin PRECAUTIONS
[46.83 KB]
Investigation
[88.56 KB]
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate
Amoxicillin hydrate

Lansoprazole/amoxicillin hydrate/
clarithromycin


Lansoprazole/amoxicillin hydrate/
metronidazole


Rabeprazole sodium/amoxicillin hydrate/clarithromycin

Rabeprazole sodium/amoxicillin hydrate/metronidazole

Vonoprazan fumarate/amoxicillin hydrate/clarithromycin

Vonoprazan fumarate/amoxicillin hydrate/metronidazole
PRECAUTIONS
[59.48 KB]
Investigation
[80.22 KB]
Potassium clavulanate/
amoxicillin hydrate

Potassium clavulanate/
amoxicillin hydrate
PRECAUTIONS
[45.80 KB]
Investigation
[80.22 KB]
Moxifloxacin hydrochloride
(oral dosage form)
PRECAUTIONS
[45.52 KB]
Investigation
[23.63 KB]
September 12,
 2017
Dabigatran etexilate methanesulfonate PRECAUTIONS
[37.28 KB]
Investigation
[24.33 KB]
Palivizumab (genetical recombination) PRECAUTIONS
[35.71 KB]
Investigation
[52.19 KB]
Interferon beta PRECAUTIONS
[37.86 KB]
Investigation
[256.35 KB]
August 3,
2017
Riociguat PRECAUTIONS
[33.24 KB]
Investigation
[91.05 KB]
Warfarin potassium
Warfarin potassium
Warfarin potassium
PRECAUTIONS
[33.20 KB]
Investigation
[26.16 KB]
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
Azithromycin hydrate
PRECAUTIONS
[33.77 KB]
Investigation
[36.37 KB]
Azithromycin hydrate PRECAUTIONS
[33.73 KB]
Investigation
[36.37 KB]
Laninamivir octanoate hydrate PRECAUTIONS
[33.71 KB]
Investigation
[25.89 KB]
July 4,
2017
Tramadol hydrochloride
Tramadol hydrochloride
PRECAUTIONS
[31.02 KB]
Investigation
[192.44 KB]
Tramadol hydrochloride PRECAUTIONS
[33.57 KB]
Investigation
[192.44 KB]
Tramadol hydrochloride/
acetaminophen
PRECAUTIONS
[30.89 KB]
Investigation
[192.44 KB]
Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate


Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate


Dihydrocodeine phosphate/
dl-methylephedrine hydrochloride/
chlorpheniramine maleate
PRECAUTIONS
[34.71 KB]
Investigation
[192.44 KB]
Dihydrocodeine phosphate/diprophylline/
dl-methylephedrine hydrochloride/
diphenhydramine salicylate/
acetaminophen/bromovalerylurea
PRECAUTIONS
[35.97 KB]
Investigation
[192.44 KB]
Codeine phosphate hydrate/cherry bark extract

Dihydrocodeine phosphate/
platycodon fluidextract/
glycyrrhiza extract/
plantago herb extract/peony root extract
PRECAUTIONS
[33.82 KB]
Investigation
[192.44 KB]
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate
Codeine phosphate hydrate

Dihydrocodeine phosphate
Dihydrocodeine phosphate
Dihydrocodeine phosphate
PRECAUTIONS
[34.31 KB]
Investigation
[192.44 KB]
Dihydrocodeine phosphate/
ephedrine hydrochloride/
ammonium chloride
PRECAUTIONS
[34.61 KB]
Investigation
[192.44 KB]
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 2 years old)
PRECAUTIONS
[34.66 KB]
Investigation
[192.44 KB]
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations with the administration for patients younger than 12 years old and without the administration for patients younger than 2 years old)
PRECAUTIONS
[34.62 KB]
Investigation
[192.44 KB]
Products containing codeine phosphate hydrate and products containing dihydrocodeine phosphate(OTC drugs)
(preparations without the administration for patients younger than 12 years old)
PRECAUTIONS
[33.60 KB]
Investigation
[192.44 KB]
Loxoprofen sodium hydrate
(Cataplasms/Gel Patches)

Loxoprofen sodium hydrate(Tape)
Loxoprofen sodium hydrate(Gel)
Loxoprofen sodium hydrate(Spray)
PRECAUTIONS
[26.09 KB]
Investigation
[31.02 KB]
Hydroxocobalamin PRECAUTIONS
[28.68 KB]
Investigation
[28.53 KB]
Nivolumab
(genetical recombination)
PRECAUTIONS
[34.91 KB]
Investigation
[31.23 KB]
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fluconazole
Fosfluconazole
PRECAUTIONS
[31.37 KB]
Investigation
[79.90 KB]
Patch test products containing gold (I) sodium thiosulfate PRECAUTIONS
[30.70 KB]
Investigation
[51.97 KB]
Loxoprofen sodium hydrate
(dermatologic preparation)
(guidance-mandatory drugs)
PRECAUTIONS
[30.63 KB]
Investigation
[28.99 KB]
May 30,
2017
Treprostinil PRECAUTIONS
[24.35 KB]
Investigation
[74.06 KB]
Dulaglutide
(genetical recombination)
PRECAUTIONS
[25.90 KB]
Investigation
[77.35 KB]
Bosutinib hydrate PRECAUTIONS
[25.94 KB]
Investigation
[77.70 KB]
Pneumococcal vaccine PRECAUTIONS
[26.14 KB]
Investigation
[32.42 KB]
April 20,
2017
Denosumab
 (genetical recombination)
(drug product with the indication for osteoporosis)
PRECAUTIONS
[31.23 KB]
Investigation
[32.76 KB]
Pembrolizumab
(genetical recombination)
PRECAUTIONS
[24.38 KB]
Investigation
[26.27 KB]
Caspofungin acetate PRECAUTIONS
[24.37 KB]
Investigation
[77.23 KB]