Download as pdf or txt
Download as pdf or txt
You are on page 1of 80

Efek Samping Obat

Fajar Wahyu Pribadi


fajarwahyupribadi@yahoo.com

Outline
Definisi
Klasifikasi
Diskusidengancontoh
Diskusidengancontoh

Definitions
AdverseEvent(AE):Anyuntowardmedicaloccurrence
Anyuntowardmedicaloccurrence
thatmaypresentduringtreatmentwithapharmaceutical
productbutwhichdoesnotnecessarilyhaveacausal
notnecessarilyhaveacausal
relationshipwiththistreatment.
withthistreatment.
AdverseDrugReaction(ADR):Anynoxiouschange
AdverseDrugReaction(ADR):
whichissuspectedtobeduetoadrug
suspectedtobeduetoadrug,occursatdoses
normallyusedinman,requirestreatmentordecreasein
doseorindicatescautioninfutureuseofthesamedrug.

Therefore,anadversedrugreactionisanadverseevent
withacausallinktoadrug.
withacausallinktoadrug.

Drugadministered
Pt.developsanewcondition/symptom

ADE
Drugsuspected?
Yes
Checkliterature

Documented?
(fortheproduct
Or
similarclassofproducts)
Yes
Highlysuggestiveof ADR

Notdocumentedinliterature
Drugcontinued

Worseningofsymptoms

Anyotherpossiblecauses?
Concomitanttherapy
Underlying conditions

Drugdiscontinued

Symptomsimprove
(+vedechallenge)

Drugrestarted

Symptomsrecur
(+verechallenge)

Simply.

Adverse: Untoward, unintended, possibly causing harm


(noxious)
AE: Adverse Event, Effect or Experience
ADE (Adverse Drug Event):: An AE which happens in a
patient taking a drug
ADR (Adverse Drug Reaction): An ADE in which a causal
association is suspected between the drug and the event

ADEsVsADRs
ADRs
Adversedrugevents
(ADEs)

AdverseDrug
Reactions
(ADRs)

Noneedtohave
acausalrelationship

Causalrelationship
issuspected/established

Fromtheearliesttimes,pharmaceutical
formulationshavebeenrecognizedas
beingpotentiallydangerous.
Indeeditisatruismthatunlessadrugis
capableofdoingsomeharmitisunlikely
todomuchgood.
Publicandprofessionalconcernabout
thesemattersfirstaroseinthelate19th
century.
In1922,therewasanenquiryintothe
JAUNDICE associatedwiththeuseof
SALVARSAN,anorganicarsenicalusedin
,anorganicarsenicalusedin
thetreatmentofSyphillis.
thetreatmentofSyphillis.

In1961,itwasreportedinWestGermany
thattherewasanoutbreakof
PHOCOMELIA (hypoplasticandaplastic
hypoplasticandaplastic
limbdeformities)inthenewbornbabies.
)inthenewbornbabies.
Itwasshownsubsequentlythat
thalidomide,anonbarbituratehypnotic,
wastoblame.
Thecrucialperiodofpregnancyduring
whichthalidomideisTERATOGENICisthe
whichthalidomideisTERATOGENICisthe
firstthreemonths.

In1937intheUSA,107peoplediedfrom
takingan ELIXIROFSULFANILAMIDE
ELIXIROFSULFANILAMIDEthat
containedthe SOLVENTDIETHYLENE
GLYCOL
Thisledtotheestablishmentofthe
ThisledtotheestablishmentoftheFOOD
ANDDRUGADMINISTRATION (FDA),
whichwasgiventhetaskofenquiringinto
thesafetyofnewdrugsbeforeallowing
themtobemarketed.
Majormoderncatastrophethatchanged
professionalandpublicopiniontowards
medicineswasthe THALIDOMIDE
THALIDOMIDE
INCIDENT.

The THALIDOMIDEINCIDENT
THALIDOMIDEINCIDENTledtoa
publicoutcry,totheinstitutionallround
theworldof DRUGREGULATORY
AUTHORITIES,tothedevelopmentofa
,tothedevelopmentofa
muchmoresophisticatedapproachtothe
preclinicaltestingandclinicalevaluationof
drugsbeforemarketing,andtoagreatly
increased awarenessofadverseeffectof
drugs and methodsofdetectingthem.
methodsofdetectingthem

Incidenceofadversedrug
reactions
Manydifferentfigureshavebeenpublished
ontheincidenceofadversedrugreactions.
Thefollowingaretherepresentingfigures.
HOSPITALINPATIENTS
PATIENTS:1020%sufferan
adversedrugreaction.
DEATHSINHOSPITALINPATIENTS:0.24
DEATHSINHOSPITALIN
2.9%areduetoadversedrugreactions.
HOSPITALADMISSIONS:0.35%ofhospital
HOSPITALADMISSIONS:
admissionsareduetoadversedrug
admissionsareduetoadversedrug
reactions.

Drug

Year

AdverseReaction Outcome

Sulfanilamide

1937

Liverdamagedue
damagedue Solventchanged
todiethyleneglycol FDAestablished

Thalidomide

1961

Congenital
Malformations

Withdrawn

Chloramphenicol

1966

BloodDyscrasias
Dyscrasias

Usesrestricted

Benoxaprofan

1982

Liverdamage

Withdrawn

Aspirin

1986

Reyessyndrome

Usesrestricted

Flecainide

1989

Cardiac
Arrhythmias

Usesrestricted

Noscapine

1991

Genetoxicity

Withdrawn

Triazolam

1991

Psychiatric
disorders

Withdrawn

drug

year

Adverse
reaction

Outcome

Temafloxacin

1992

Variousserious
adverseeffects

Withdrawn

Cotrimoxazole

1995

Seriousallergic
reactions

Usesrestricted

Terfenadine

1997

Interactions
(e.g.with
grapefruitjuice)

Withdrawn from
OTCsale

Sotalol

1997

Cardiac
arrhythmias

Usesrestricted

Astemizole

1998

Interactions

Withdrawn

Cisapride

2000

Cardiac
arrhythmias

Withdrawn

Cerivastatin

2001

Rhabdomylosis

Withdrawn

Classification
Classification

Classification
Onsetofevent:Acute(<60minutes),Sub
Acute(<60minutes),Subacute(124hrs)
andLatent(>2days)
Typeofreaction:TypeA(Augmented),B(Bizarre),C
TypeA(Augmented),B(Bizarre),C
(Chemical),D(Delayed),E(Exit),F(Familial),G
),E(Exit),F(Familial),G
(Genotoxicity),H(Hypersensitivity
Hypersensitivity),U(Unclassified)
Severity:Minor,Moderate,Severe,LethalADRs
Minor,Moderate,Severe,LethalADRs
Others:Sideeffects,Secondaryeffects,Toxiceffects,
Sideeffects,Secondaryeffects,Toxiceffects,
Intolerance,Idiosyncrasy,Drugallergy,
Photosensitivity,DrugDependence,DrugWithdrawal
Reactions,Teratogenicity,Mutagenicity,
Carcinogenicity,Druginduceddisease(Iatrogenic)
Carcinogenicity,Druginduceddisease(Iatrogenic)

ClassificationofADRs....
Willsandbrown
TypeA(Augmented)
TypeB(Bizarre)
TypeC(Chemical)
TypeD(Delayed)
TypeE(Exit/Endoftreatment)
TypeE(Exit/Endoftreatment)
TypeF(Familial)
TypeG(Genotoxicity)
TypeH(Hypersensitivity)
TypeU(Unclassified)

TypeA(Augmented)reactions
TypeA(Augmented)reactions
Reactions which can be predicted from the known
pharmacology of the drug
Dose dependent,
Can be alleviated by a dose reduction
E.g.
Anticoagulants Bleeding,
Beta blockers Bradycardia,
radycardia,
Nitrates Headache,
Prazosin Postural
ostural hypotension.

TypeB(Bizarre)reactions
Cannotbepredictedfromthepharmacologyof
thedrug
Notdosedependent,
Hostdependentfactorsimportantin
predisposition
E.g.
Penicillin
PenicillinAnaphylaxis,
Anticonvulsant
AnticonvulsantHypersensitivity

Type C (Chemical) reactions


Biological characteristics can be predicted

from the chemical structure of the


drug/metabolite
E.g.
Paracetamol H

Hepatotoxicity
epatotoxicity

TypeD(Delayed)reactions
Occuraftermanyyearsoftreatment.
Canbeduetoaccumulation.
E.g.
ChemotherapySecondarytumours
Secondarytumours
Phenytoinduringpregnancy
Teratogeniceffects
AntipsychoticsTardivedyskinesia
Tardivedyskinesia
AnalgesicsNephropathy

TypeE(Endoftreatment)
reactions
Occuronwithdrawalespeciallywhendrugis
stoppedabruptly
E.g.
PhenytoinwithdrawalSeizures,
Phenytoinwithdrawal
Steroidwithdrawal
Adrenocorticalinsufficiency.

ClassificationofADRs.
DependingonSeverity
MinorADRs:Notherapy,antidoteor
Notherapy,antidoteor
prolongationofhospitalizationis
required.
ModerateADRs:Requireschangein
Requireschangein
drugtherapy,specifictreatmentor
prolongshospitalstaybyatleast1day
prolongshospitalstaybyatleast1day.
SevereADRs:Potentiallylife
Potentiallylife
threatening,causespermanentdamageor
requiresintensivemedicaltreatment.
Lethal: Directlyorindirectlycontributes
Directlyorindirectlycontributes
todeathofthepatient.

Side effects
Unwantedbutoftenunavoidable,pharmacodynamiceffects
thatoccurattherapeuticdoses
Predictedfromthepharmacologicalprofileofadrug
Knowntooccurinagivenpercentageofdrugrecipients
E.g.
Sideeffectbasedontherapeuticeffect:
Atropine(preanaesthetic)drynessofmouth
drynessofmouth
Acetazolamide(diureticbicarbonateexcretion)
bicarbonateexcretion)Acidosis
Sideeffectbasedonadifferentaction:
Promethazine(antiallergic)sedation
Estrogen(Antiovulatory)Nausea
Nausea
Dependingonthecontext:
Codeine(antitussive)constipation
constipationUsedinTravellers
diarrhea

Sideeffects.
Drugdiscovery
Occasionally,adverseeffectsmaybeexploited
todevelopanentirelynewindicationforadrug.
E.g:
UnwantedhairgrowthduringMinoxidiltreatment
ofseverelyhypertensivepatients
ofseverelyhypertensivepatientsdevelopment
ofthedrugforhairgrowth.
Sildenafilwasinitiallydevelopedasan
antianginal,butitseffectstoalleviateerectile
dysfunctionanewdrugindicationinerectile
anewdrugindicationinerectile
tissue.
Sulfonamidesusedasantibacterialswerefound
toproducehypoglycemiaandacidosisasside
effects developmentofHypoglycemic
developmentofHypoglycemic
SulfonylureasandCarbonicanhydraseinhibitor
SulfonylureasandCarbonicanhydraseinhibitor
Acetazolamide.

Secondaryeffects
Indirectconsequencesofaprimaryactionofthe
drug
E.g.
Tetracyclines Suppressionofbacterialflora
Suppressionofbacterialflora
Superinfections
Corticosteroids Weakenhostdefence
Weakenhostdefence
Activationoflatenttuberculosis
Activationoflatenttuberculosis

Toxic effects
Result of excessive pharmacological action of
the drug due to over dosage or prolonged use.
Over dosage may be
1.
2.

Absolute (Accidental, homicidal, suicidal)


Relative (Gentamycin
(
in Renal failure)

Result from
1. Extension of therapeutic effect:
E.g. Barbiturates Coma,
Digoxin Complete A-V block,
Heparin Bleeding
2. Functional alteration:
E.g. Atropine Delirium
3. Drug induced tissue damage:
E.g. Paracetamol Hepatic necrosis

Intolerance
Appearance of characteristic toxic effects of a drug in an
individual at therapeutic doses
Converse of tolerance,
Indicates a low threshold of the individual
E.g.
Triflupromazine (single dose) Muscular dystonias in
some individuals
Carbamazepine (few doses) Ataxia in some individuals
Chloroquine (single tablet) Vomiting and abdominal pain
in some individuals

Idiosyncrasy
Geneticallydeterminedabnormalreactivitytoa
chemical
CertainBizarredrugeffectsduetopeculiaritiesof
anindividualforwhichnodefinitegenotypehas
beendescribed,arealsoincluded.
Druginteractswithsomeuniquefeatureofthe
individual,notfoundinmajoritysubjects,and
producestheuncharacteristicreaction.
E.g.
BarbituratesExcitementandmentalconfusionin
Excitementandmentalconfusionin
someindividuals
QuinineCramps,diarrhea,asthma,vascular
Cramps,diarrhea,asthma,vascular
collapseinsomeindividuals
Chloramphenicol Aplasticanemiainrareindividuals

Drugallergy
Immunologicallymediatedreactionproducingstereotypesymptoms,
unrelatedtothepharmacodynamicprofileofthedrug
Generallyoccurevenwithmuchsmallerdoses
AlsocalledDrughypersensitivity

Nonspecific Types:defectiveorabsentenzymes,cytokine
dysabalance, dysbalance ofinflammatorymediators,nonspecificmast
cell degranulation
SpesificTypes:
TypeI:Immediate,anaphylactic(IgE
IgE)
E.g: Penicillins Anaphylaxis
TypeII: Cytotoxic antibody(IgG, IgM)
IgM
Humoral
immunity
E.g: Methyldopa hemolyticanemia
TypeIII:Serumsickness(IgG, IgM)
Antigenantibodycomplex
E.g: Procainamideinducedlupus
inducedlupus
TypeIV:Delayedhypersensitivity(Tcell)
Cellmediated
immunity
E.g: Contactdermatitis

LowBirthWeightInfant
Infantlessthan2500g
Glucocorticoidscausesgrowthrestriction
Prenatalexcessofglucocorticoidsmodifiesthe
developmentofseveralorgans,includingthelung,
heart,gut,andkidney
heart,gut,andkidney

Gradingsystemforhypersensitivity
reactionsincludinganaphylaxis
Grade

Broadclinicalfeatures

Deningsymptomsandsigns

1
Mild
2
Moderate

Cutaneousandsubcutaneous Generalizederythema,periorbitaledema,
only
urticaria,orangioedema
Cardiovascular,respiratory,or
gastrointestinalinvolvement

Dyspnea,stridor,wheeze,nausea,vomiting,
dizziness,diaphoresis,chestorthroat
tightness,orabdominalpain

3
Severe

Hypoxia,hypotension,or
neurologiccompromise

=92%atanystage,hypotension(systolic
BP<90mmHginadults),confusion,
collapse,lossofconsciousness,or
incontinenceCyanosisorSpO2

AdaptedfromBrownSGA.Clinicalfeaturesandseveritygradingofanaphylaxis.JAllergy Clin Immunol2004;114:317


AdaptedfromBrownSGA.Clinicalfeaturesandseveritygradingofanaphylaxis.JAllergy
withkindpermissionfromElsevierLimited

SummaryForHypersensitivity
ForHypersensitivity
TypeI

TypeII

TypeIII

TypeIV

Other
designations

Immediate;
anaphylactic

Cytotoxic

Immune
complex

Delayed;cell
mediated;
Tcellmediated

Timefor
reaction

Secondsto30
min

Hours(~1day)

310h

2472h

Druginduced
induced
hemolytic
anemia,
thrombocytope
nia,
agranulocytosis
(immuneform)

Serum
sickness;
Druginduced
vasculitis

Allergiccontact
dermatitis;
Psoriasis;
Maculopapular
exanthema;
AGEP;FDE; SJS;
DRESS; TEN;EM

Examples
Erythema;
ofdiseasestates urticaria;
angioedema;
respiratory
symptoms;
GIsymptoms;
anaphylaxis

Generalizedurticaria(hives)
Generalizedurticaria(hives)

Acaseofseveregeneralizedchronic urticaria andnonlife


Acaseofseveregeneralizedchronic
threatening angioedema unresponsivetoantihistamines
unresponsivetoanti

Angioedema
Angioedemaofthefaceshowingnon
Angioedemaofthefaceshowingnon
pruriticswellingofthecutaneoustissues
withsomeerythema.
Angioedemapersistslongerthan
urticariaduetotheaccumulatedfluidin
urticariaduetotheaccumulatedfluidin
thetissues.

Atlasofallergicdiseases;
2002;IS:08.WithkindpermissionfromSpringer
Science+BusinessMediaB.V

ContactDermatitis
Allergicnickelcontactdermatitis
causedby
( a) readingglassesand
( b)amultifunctionkeyonacell
phone.

FromVeienNK,in:JohansenJD,FroschPJ,
LepoittevinJP,editors.ContactDermatitis.5thed.
P,editors.ContactDermatitis.5thed.
Berlin:SpringerVerlag;2011.Withkindpermission
Verlag;2011.Withkindpermission
from
SpringerScience+BusinessMedia

Acuteallergiccontactdermatitistothetopicalantiviral
tromantadinehydrochlorideshowingblistering
tromantadinehydrochlorideshowingblistering

PsoriaticEruptions
occurin3.445%of
patientstreatedwith
lithium.
Themechanismis
currentlybelievedtobe
byinhibitionofthe
intracellularreleaseof
calciumasaresultof
lithiuminduced
depletionof inositol
monophosphatase.

Generalized maculopapular
Generalized
exanthema
followingthe introductionof
followingthe
amoxicillintherapyshowing
amoxicillin
lesionsonthetrunk (a)and
lesionson
targetedlesionsonthe hands
targetedlesions
andforearms( b).
andforearms
Thepatienthad :
Thepatient
positive(+)patchtests to
positive(+)patch
amoxicillinandampicillin
amoxicillinand
and negative()tests
negative(
to
benzylpenicillin dicloxacillin,
benzylpenicillin,
andanumberof
andanumber
cephalosporins
cephalosporins.

AGEP

AcuteGeneralized
ErythematousPustulosis
tohydroxychloroquine
sulfate
sulfate

DRESS
Apatientwithdrugreaction(orrash)
witheosinophiliaandsystemic
symptoms(DRESS),alsoreferredtoas
hypersensitivitysyndromeordrug
inducedhypersensitivitysyndrome.The
patientexperiencedsystemic
symptoms,skinreactionswith
nonspecificmaculopapularrash,and
exfoliativedermatitiswithfacialedema

(photographcourtesyofDr.AdrianMar)

FixedDrugEruption
Inafewcases,lesionscanbesowidespread
thatitisdifficulttodistinguishFDEfromTEN.
FDEissonamedbecausethesiteofthe
eruptionis FIXED
itoccursinexactlythesameplacewhenthe
samedrugisagainencountered
samedrugisagainencountered

FixedDrug
Eruption
Afixeddrugeruptionshowingthe
characteristic,oftenseencircular
seencircular
shape.Lesionsoftenresolvewith
shape.Lesionsoftenresolvewith
postinflammatorypigmentation

(photographcourtesyof
Dr.AdrianMar)

Awellcircumscribedbullousxeddrugeruption
circumscribedbullousxeddrugeruption
Thereactionwasinducedby
carbamazepine,
adrugimplicatedinsome
severedruginduceddelayed
hypersensitivityresponses

Erythema Multiforme
Aselflimitingcutaneoushypersensitivity
limitingcutaneoushypersensitivity
reactiontoinfection(mostly)ordrugs
Occurringmainlyinadults20
Occurringmainlyinadults2040yearsofage
(althoughitcanoccurinpatientsatanyage)
Prodromalsymptomsareeitherlackingormild
(itch,burning)
usuallyresolvesspontaneouslyin3
usuallyresolvesspontaneouslyin35weeks
withoutsequelae

ErythemaMultiforme
ErythemaMultiforme

Potentiallyfatal,severe,rare,
adversecutaneousdrugreactions
Lesionsdevelop acentral bulla
andcoalesceintolargesheetsof
necrotictissuecoveringatleast
30%ofthe bodyin thecaseof

ToxicEpidermal Necrolysis

Lipsandfacialinvolvementina
childwithdevelopingdrug
induced StevensJohnson

syndrome

SummaryForHypersensitivity
ForHypersensitivity
Type DrugsImplicated
DrugsImplicated
Type

II
II
II

Lactams;someNSAIDs;quinolones
quinolones;mAbs;PPI
Lactams;someNSAIDs;quinolones
quinolones;mAbs;PPI

III
III

Lactams;ciprooxacin;sulfonamides;
ciprooxacin;sulfonamides;
;sulfonamides;lincomycin;tetracycline;NSAIDs;
tetracycline;NSAIDs;
Lactams;
;sulfonamides;lincomycin;
carbamazepine;allopurinol;gold;
gold;methyldopa;mAbs
carbamazepine;allopurinol;gold;
gold;methyldopa;mAbs

IV
IV

NSAIDs;lactams;otherantibiotics;anticonvulsants;antimalarials;
otherantibiotics;
otherantibiotics;anticonvulsants;antimalarials;
NSAIDs;lactams;
otherantibiotics;
localanesthetics;barbiturates;quinolones
anesthetics;barbiturates;quinolones;dapsone
quinolones;dapsone
local

Lactams;quinine;quinidine;sulfonamides;
;sulfonamides;NSAIDs;procainamide;gold;
Lactams;quinine;quinidine;sulfonamides;
;sulfonamides;NSAIDs;procainamide;gold;
carbamazepine;PTU;
carbamazepine;PTU;

Photosensitivity

Cutaneous reaction resulting from drug induced


sensitization of the skin to UV radiation. The reactions
are of two types

Phototoxic: Drug or its metabolite accumulates in the


skin, absorbs light and undergoes a photochemical
reaction resulting in local tissue damage (sunburnlike,
(sunburn
i.e., erythema, edema, blistering, hyper pigmentation)
E.g. Tetracyclines (esp. Demeclocycline), and
Tar products, Nalidixic acid, Fluoroquinolones, Sulfones
etc

Photo allergic: Drug or its metabolite induces a cell


mediated immune response which on exposure to light
(longer wave length) produces a papular or eczematous
contact dermatitis like picture.
E.g. Sulfonamides, Sulfonylureas, Griseofulvin,
Chloroquine, Chlorpromazine

Drugdependence
Drugscapableofalteringmoodandfeelingsareliabletorepetitive
usetoderiveeuphoria,withdrawalfromreality,socialadjustment,
etc.
Psychologicaldependence:
Psychologicaldependence: Individualbelievesthatoptimalstate
ofwellbeingisachievedonlythroughtheactionsofthedrug.
E.g.Opioids,Cocaine.
Physicaldependence: Alteredphysiologicalstateproducedby
repeatedadministrationofadrugwhichnecessitatesthecontinued
presenceofthedrugtomaintainphysiologicalequilibrium.
Discontinuationofthedrugresultsinacharacteristicwithdrawal
(abstinence)syndrome.
E.g.Opioids,Barbiturates,Alcohol,Benzodiazepines
Opioids,Barbiturates,Alcohol,Benzodiazepines

Drugdependence.
Drugabuse:Useofadrugbyselfmedicationinamanner
Useofadrugbyselfmedicationinamanner
andamount,thatdeviatesfromtheapprovedmedicaland
socialpatternsinagivencultureatagiventime.
Drugabusereferstoanyuseofanillicitdrug.
Drugaddiction:Compulsivedrugusecharacterizedby
Compulsivedrugusecharacterizedby
overwhelminginvolvementwiththeuseofadrug.
Drughabituation:Lessintensiveinvolvementwiththedrug,
Lessintensiveinvolvementwiththedrug,
withdrawalproducesonlymilddiscomfort.
Habituationandaddictionimplydifferentdegreesof
psychologicaldependence.
psychologicaldependence.

Drugwithdrawalreactions
Suddeninterruptionoftherapywithcertaindrugsresultin
adverseconsequences,mostlyintheformofworsening
oftheclinicalconditionforwhichthedrugwasbeing
used.
E.g:
CorticosteroidAdrenalinsufficiency
Adrenalinsufficiency
blockersworseningofangina,precipitationofMI
worseningofangina,precipitationofMI
ClonidinesevereHTN,restlessness,sympatheticover
severeHTN,restlessness,sympatheticover
activity

Teratogenicity

Capacity of a drug to cause foetal abnormalities when


administered to the pregnant mother.
Drugs can affect the foetus at 3 stages:
1. Fertilization and implantation (Conception to 17 days):
failure of pregnancy which often goes unnoticed.
2. Organogenesis(18 days to 55 days): most vulnerable
period, deformities are produced.
3. Growth and development (> 56 days): developmental and
functional abnormalities can occur.
occur.

E.g:
Thalidomide Phocomelia,
Phocomelia, multiple defects
defects
Anticancer drugs Cleft palate, hydrocephalus,
multiple defects
ACE inhibitors Hypoplasia of organs (lungs, kidney)

MutagenecityandCarcinogenicity
Capacityofadrugtocausegeneticdefectsand
cancerrespectively.
Chemicalcarcinogenesisgenerallytakesseveral
(1040)yearstodevelop.
40)yearstodevelop.
E.g.
Anticancerdrugs,
Radioisotypes,
isotypes,
Estrogens,
Tobacco.

Druginduceddisease
AlsocalledIatrogenic(Physicianinduced)diseases.
Functionaldisturbancescausedbydrugswhichpersist
evenaftertheoffendingdrughasbeenwithdrawnand
largelyeliminated

E.g.
Salicylates,Corticosteroids
Pepticulcer
Phenothiazines,otherantipsychotics
Phenothiazines,otherantipsychoticsParkinsonism
IsoniazidHepatitis
HydralazineDLE

Summary
Adverse Drug Reactions (ADRs) are adverse events with a causal link
to a drug.
Types of Classification of ADRs:
Predictibility : A & B
Onset of event: Acute (<60 minutes), Subacute
Sub
(124 hrs) and Latent (>2
days)
Type of reaction: Type A (Augmented), B (Bizarre), C (Chemical),D
(
(Delayed),
), E (Exit), F (Familial), G (Genotoxicity),
(
H (Hypersensitivity), U
(Un classified)
Severity: Minor, Moderate, Severe, Lethal ADRs
Others: Side effects, Secondary effects, Toxic effects, Intolerance,
Idiosyncrasy, Drug allergy, Photosensitivity, Drug Dependence, Drug
Withdrawal Reactions, Teratogenicity, Mutagenicity, Carcinogenicity, Drug
induced disease (Iatrogenic)

You might also like