RUCAMCausalityAssessment

Drug:_______________________________InitialALT:__________InitialAlkP:__________Rratio=[ALT/ULN][AlkP/ULN]=_______________=________
TheRratiodetermineswhethertheinjuryishepatocellular(R>5.0),cholestatic(R<2.0),ormixed(R=2.05.0)
HepatocellularType CholestaticorMixedType Assessment
1.Timetoonset
InitialTreatment Subsequent InitialTreatment SubsequentTreatment Score(checkoneonly)
Treatment
o Fromthebeginningofthedrug:
Suggestive 590days 115days 590days 190days +2
Compatible <5or>90days >15days <5or>90days >90days +1

o Fromcessationofthedrug:
Compatible 15days 15days 30days 30days +1
Note:Ifreactionbeginsbeforestartingthemedicationor>15daysafterstopping(hepatocellular),or>30daysafterstopping(cholestatic),theinjuryshouldbeconsideredunrelated
andtheRUCAMcannotbecalculated.

2.Course ChangeinALTbetweenpeakvalueandULN ChangeinAlkP(ortotalbilirubin)betweenpeak Score(checkoneonly)

valueandULN
Afterstoppingthedrug:

Highlysuggestive Decrease50%within8days Notapplicable +3

Suggestive Decrease50%within30days Decrease50%within180days +2

Compatible Notapplicable Decrease<50%within180days +1

Inconclusive Noinformationordecrease50%after30days Persistenceorincreaseornoinformation 0

Againsttheroleofthedrug Decrease<50%after30daysOR
Recurrentincrease Notapplicable 2
o Ifthedrugiscontinued:
Inconclusive Allsituations Allsituations 0

3.RiskFactors: Ethanol EthanolorPregnancy(either) Score

(checkoneforeach)
o AlcoholorPregnancy Presence Presence +1
Absence Absence 0
o Age Ageofthepatient55years Ageofthepatient55years +1
Ageofthepatient<55years Ageofthepatient<55years 0

4.Concomitantdrug(s): Score(checkoneonly)
o Noneornoinformationorconcomitantdrugwithincompatibletimetoonset 0
o Concomitantdrugwithsuggestiveorcompatibletimetoonset 1

o Concomitantdrugknowntobehepatoxicwithasuggestivetimetoonset 2
o Concomitantdrugwithclearevidenceforitsrole(positiverechallengeorclearlinktoinjuryandtypicalsignature) 3

5.Exclusionofothercausesofliverinjury: Score(checkoneonly)

GroupI(6causes): o AllcausesinGroupIandIIruledout +2
o AcuteviralhepatitisduetoHAV(IgMantiHAV),or
o HBV(HBsAgand/orIgMantiHBc),or o The6causesofGroupIruledout +1
o HCV(antiHCVand/orHCVRNAwithappropriateclinicalhistory)
o Biliaryobstruction(Byimaging) o Fiveor4causesofGroupIruledout 0
o Alcoholism(HistoryofexcessiveintakeandAST/ALT2)
o Recenthistoryofhypotension,shockorischemia(within2weeksofonset) o Lessthan4causesofGroup1ruledout 2
GroupII(2categoriesofcauses):
o Complicationsofunderlyingdisease(s)suchasautoimmunehepatitis,sepsis,chronichepatitis o Nondrugcausehighlyprobable 3
BorC,primarybiliarycirrhosisorsclerosingcholangitis;or
o ClinicalfeaturesorserologicandvirologictestsindicatingacuteCMV,EBV,orHSV.

6.Previousinformationonhepatotoxicityofthedrug: Score(checkoneonly)
o Reactionlabeledintheproductcharacteristics +2
o Reactionpublishedbutunlabeled +1

o Reactionunknown 0

7.Responsetoreadministration: Score(checkoneonly)
o Positive DoublingofALTwithdrugalone DoublingofAlkP(orbilirubin)withdrugalone +3

o Compatible DoublingoftheALTwiththesuspectdrug DoublingoftheAlkP(orbilirubin)withthesuspect +1

combinedwithanotherdrugwhichhadbeen drugcombinedwithanotherdrugwhichhadbeen
givenatthetimeofonsetoftheinitialinjury givenatthetimeofonsetoftheinitialinjury
o Negative IncreaseofALTbutlessthanULNwithdrug IncreaseofAlkP(orbilirubin)butlessthanULNwith 2
alone drugalone
o Notdoneornotinterpretable Othersituations Othersituations 0

TOTAL(addthecheckedfigures)
Abbreviationsused:ALT,alanineaminotransferase;AlkP,alkalinephosphatase;ULN,upperlimitofthenormalrangeofvalues
Modifiedfrom:DananGandBenichouC.JClinEpidemiol1993;46:132330.