NARANJO ALGORITHM
Q1: Are there previous conclusive reports on this Q4: Did the adverse event reappear when the drug
reaction? was readministered?
• Yes” (+1) applies if there have been two or more • “Yes” (+2) indicates that the medication was
published reports in which the adverse reaction stopped, the adverse event resolved or
has been described in detail or if the adverse improved, and there was an unequivocal
reaction is listed in a reliable source reappearance or worsening of the reaction
• “No” applies when the adverse event has not when the medicine was restarted in a similar
been described previously or if only one report dose and by the same route. The Naranjo scale
has been published, or if published reports were also allows for a “Yes” if the causal association is
considered inconclusive or unconvincing well known and rechallenge cannot be done for
• “Do not know” is applicable only when there is clinical or ethical reasons.
no information, because the agent has not been • “No” (-1) only applies if rechallenge was done,
available for an adequate period of time or has but the adverse event did not reappear or
not been previously evaluated for this adverse worsen
reaction • “Do not know” (0) applies if rechallenge was not
done or information on rechallenge is not
Q2: Did the AE appear after the suspected drug was available or the reaction was ambiguous.
administered?
• Yes” (+2) applies if there is definitive evidence Q5: Are there alternative causes that could on their
that the adverse event occurred after the own have caused the reaction?
medication was started. • “Yes” (-1) applies when there is an alternative
• “No” (-1) applies when the adverse event cause or explanation.
developed before the first dose of the drug. • “No” (+2) applies if alternative causes have been
• “Do not know” (0) applies if the information is excluded, based upon a systematic and
not available or is unclear. complete evaluation, thus implicating the drug
more strongly. A risk or susceptibility factor is
Q3: Did the adverse event improve when the drug not an alternative cause.
was discontinued or a specific antagonist was • “Do not know” (0) applies if the investigation of
administered? other causes is incomplete, inconclusive or was
• “Yes” (+1) applies if the adverse event not done.
diminishes or disappears at any time after
stopping the medication, or if the reaction Q6: Did the reaction reappear when a placebo was
disappears upon administration of a specific given?
pharmacologic antagonist (for example, an • “Yes” (-1) applies if the medication was stopped
anticholinergic given for a cholinergic reaction and the adverse reaction resolved or improved
to physostigmine) conclusively, and there was an unequivocal
• “No” (0) applies if the adverse event does not reappearance of the adverse event after
improve or improves in response to a administration of placebo (single or double
nonspecific therapy or an antidote to another blind).
medication or treatment of the underlying • “No” (+1) applies if the reaction did not
disease. reappear or worsen after administration of
• “Do not know” (0) applies if the medication was placebo.
not stopped or the subsequent course was • “Do not know” (0) applies if placebo challenge
unknown, inconclusive or unclear. was not done or the results were inconclusive.
Q7: Was the drug detected in blood or other fluids Q10: Was the adverse event confirmed by any
in concentrations known to be toxic? objective evidence?
• “Yes” (+1) applies if the concentration is in the • “Yes” (+1) indicates that there is laboratory test
accepted toxic or supratherapeutic range. documentation of the adverse event or that the
• “No” (0) applies if the concentration is below event was directly observed by a qualified
the toxic range. person (for example, a skin rash described in
• “Do not know” (0) applies if drug levels are not nursing or physician notes).
available or are inconclusive. • “No” (0) applies when neither laboratory tests
nor direct clinical documentation can verify the
Q8: Was the reaction more severe when the dose reaction.
was increased or less severe when the dose was • “Do not know” (0) applies if there is no specific
decreased? information available (no laboratory testing and
• “Yes” (+1) applies if the adverse event was more no clinical description) or the information is
severe or worsened when the dose of the inconclusive.
medication was increased, or was less severe • The scores given for “No” and “Do not know”
and improved when the dose was decreased. are the same (0), so it is not critical to decide
• “No” (0) applies if there was no appreciable between these two answers.
change in the severity of the adverse event with
dose modification.
• “Do not know” (0) applies if the dose or
regimen was not altered or the information was
not available or inconclusive.
Q9: Did the patient have a similar reaction to the
same or similar drugs in any previous exposure?
• “Yes” (+1) applies when there is documentation
of a previous similar reaction to the specific drug
or a related medication.
• “No” (0) applies when the patient does not have
a previous exposure to the same medicine or
when the patient did not develop the adverse
reaction in a previous exposure to the same or
related drugs.
• “Do not know” (0) applies when there is no
information on previous reactions or the
information is inconclusive.
PROBABILITY RESULTS
• Doubtful ADR (<2): The reaction was likely related to factors other than a drug).
• Possible ADR (2 to 4): The reaction followed a temporal sequence after a drug, possibly followed a recognized
pattern to the suspected drug and could be explained by characteristics of the patient’s disease.
• Probable ADR (5 to 8): The reaction followed a reasonable temporal sequence after a drug, followed a
recognized response to the suspected drug, was confirmed by withdrawal but not by exposure to the drug,
and could not be reasonably explained by the known characteristics of the patient’s clinical state.
• Definite ADR (≥9): The reaction followed a reasonable temporal sequence after a drug or in which a toxic drug
level had been established in body fluids or tissues, followed a recognized response to the suspected drug and
was confirmed by improvement on withdrawing the drug and reappeared on reexposure.
