ADR

(Adverse Drug Reaction)

2011.08.26

ADR
ADR
ADR
ADR
ADR
ADR

:
~
~
~


:955
4

45-1

-92
45-1


WHO:

FDA:





:


Type A Reaction
Predictable ()

Type B Reaction
Unpredictable ()


(93/08/31)

3:


(93/08/31)

5
()()

ADR
ADR

ADR

ADR

ADR

Naranjo

1.

+1

2.

+2

-1

3.

+1

4.

+2

-1

6.

-1
-1

+2
+1

0
0

7.

+1

8.

+1

9.

+1

+1

5.

10.

Definite

5~8

Probable

1~4

Possible

Unlikely

99ADR

1.Antihistamine
agent (2)

Clarityne (headache)

Finska-LP 1 bid

99ADR

2.Anti-infection agent and

Immunosuppresio-ns(15)

Minoline(vertigo)

Ocillina (WBC)

Pisutam(thrombocytopenia)

Curam 1000mg(pruritic skin rash )

Augcin 1.2g inj()

Cefazolin(morbiliform rash)

Lamisil(taste disturbance)

Spasmo-euvernil

Keflex

Refexindiarrhea

Cekodin eyes edema

Klaricid (skin rashFace redness)

Flagyl diarrhea

99ADR

3.Respiratory
agent (2)

Medicon-A(Fixed drug euption)

Singulair skin rash

99ADR

4.Cardiovascular
agent (23)

Coxine20mg(palpitation)(headache) 3
Moreez(cough) (skin itching)

Hysartan(cough) (constipation)

Zestril(cough)

Amtrel()

Fluitran()

Royatec cough

Amcopineedema headache

Adalat OROS

99ADR

4.Cardiovascul
ar agent (23
)-2

Diovan (dizzinesslower back

soreness)
Pavatinabdominal pain leg
cramping

Fenogal 200mg

Lescol XL(constipation
insomnia

Vytorin

Lasynheadache palpitation

Syntamskin itching

99ADR

5. CNS agent
(8)

CephadolDizziness

Midazophlebitis

Tofranilconstipation

Camapine(dizzinessnausea)

Provivenausea vomiting

Stilnox ()

99ADR

6.Musculokeletal agent (NSAID)(14)

Painil()general skin urticaria

Voreneyelid edemaeye and throat edema 3

face edema
Keto inj() (skin itchingface eyelid

swelling)
Keto 10mg()(heartburn)

Acemet eyelid edema

Ponstan skin rash

Scanol (Fixed Drug eruption)

Bolaxin eyelid edema

99ADR

7.Gastrointestinal Vesyca(skin itching,blurred vision)

agent (8)

Urotrol (blurred vision)

Mopride()

Kowell(constipation)

Dampurine(cold sweatingcold
sensation)

Buscopan ()

Dimotilskin rash over face & hand1

NovamineDizziness

99ADR

8.Hormone agent( 7)

Antigluco 850mgdiarrhea 2
Glucophage 500mg (nasuea)

Amarine (epigastralgia)

Glutazone(chest discomfortsleepy)

Glucobay (anorexia,nausea)

Levemir()

99ADR

9. Other (3)

Pneumovax ()

Cytron(GI upset,nausea,anorexia)

Covaxin ()

82

99

44

50

50
40

40

30

30

20

20

10

43

93

10
0


99

1.Antihistamine agent

2.Anti-infection agent

15

3.Respiratory agent
4.Cardiovascular agent

5.CNS agent
6. Musculokeletal agent (NSAID)

23
23
8
14

7.Gastrointestinal agent

8.Hormone agent

9.Other

82

ADR

99

Keto (ketorolac)

44

Glucomine (Metformin HCl)

Minoline (Minocycline HCl)

Voren (Diclofenac)

Painil (Flurbiprofen)

Coxine (Isosorbide-5-mononitrate)

ADR

99

1.

2.

26
26

3.

13

4.

5.

20

6.

7.

11

ADR

Type A

Type B

30

52

99

82

68

14

82

99

ADR
99

ADR

8.,
, 9.80%

1.

14

17.1%

2.,

14

17.1%

3.,

38

46.3%

4.,

3.7%

5.,

2.4%

6.

2.4%

7.,

8.,

9.8%

9.

1.2%

10.

82

100%

1., 17.10%

4.,
, 3.70%

2.,,
17.10%
3.,,
46.30%

ADR
99

50.00%

1.

35

42.7%

2.

18

22%

40.00%

3.

29

35.3%

30.00%

4.

5.

6.

10.00%

7.

0.00%

8.

9.

10.

11.

12.

82

100%

20.00%

1
.

2
.

3
.

4
.

5
.

6
.

7
.

8
.

9
.

1
0
.

1
1
.

1
2
.


:adr.doh.gov.tw

ADR

99

1%

98

2266

7939

10320

97

10

1322

6977

8316

96

1191

5777

6971

95

777

3851

4629

77%

22%

98ADR10

Diclofenac

rash,eyelid oedema,rash pruritic,pruritus,angioedema,eye swelling,

dyspnoea,SJS,urticaria,eye pain,anaphylactic shock,gastrointestinal
haemorrhage

Ketorolac

eyelid oedema,rash,rash pruritic,angioedema,eye swelling,pruritus,

urticaria,dyspnoea,anaphylactic shock,hypersensitivity

Diatrizoic acid

rash,rash pruritic,nausea,vomiting,dyspnoea,sneezing,flushing,eyelid
oedema,chest discomfort,urticaria

Acetylsalicylic acid

eyelid oedema,rash,eye swelling,rash pruritic,angioedema,dyspnoea

gastrointestinal haemorrhage,urticaria,gastric ulcer,ioxitalamic acid

Ioxitalamic acid

rash,rash pruritic,vomiting,urticaria,nausea,pruritus,anaphylactic
shock,drug eruption,dizziness,dyspnoea,eyelid oedema

Cefazolin

rash,rash pruritic,dyspnoea,anaphylacticshockeyelidoedema
,vomiting,urticaria,anaphylactic reaction,SJS

Vancomycin

rash,red man syndrome,rash pruritic,pruritus,leukopenia,flushing,

neutropenia,renal failure ,acute,thrombocytopenia,pyrexia

Erlotinib

rash,treatment failure,disease progression,pyrexia,diarrhoea,

pneumonia,bile duct obstruction,paronychia,drug ineffective,
vomiting,docetaxel,

Docetaxel

Febril eneutropenia,pyrexia,diarrhoea,neutropenia,pneumonia,
vomiting,agranulocytosis,cellulitis,rash,anaemia,disease progression,

Sunitinib

disease progression,pyrexia,thrombocytopenia,abdominal
pain,urinary tract infection,vomiting

:
E-mail
adr@tdrf.org.tw


KEYADR

5()
ADR

8key

KEYADR

6() :D.IC

://

4.:

~ADR

(1)
(2)

Taiwan Drug Releif
FoudationTDRF


:http://www.tdrf.org.tw


(2011/04/19)

(off-label use)


Stevens-Johnson syndrome (SJS)

 %


/

SJS
a. (Sulfonamide) :Baktar
b. NSAIDButazone Oxicams
-Piroxicam FeldeneTenoxicamTilcotil
DiclofenacvorenPropionix acid
c. PhenobarbitalLuminal Phenytoin
DilantinCarbamezepineTegretal
d. Allopurinol
e. ChlormezanoneTensolax
f. Corticosteroid
g. ClobazamFrisium


Carbamazepine
Allopurinol
SJS

44CarbamazepineSJS
101
HLA-B*1502
SJS
51Allopurinol
13551
HLA-B*580120

1.3.2.6 Carbamazepine100/8/1
1.
(1)carbamazepineIC
HLA-B 1502
carbamazepine
(2)carbamazepine
HLA-B
1502
2.
4
Steven-Johnson

3.carbamazepine


http://drug.doh.gov.tw
http://adr.doh.gov.tw

http://www.tdrf.org.tw

http://www.nhi.gov.tw