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SUSPECTED ADVERSE DRUG REACTION REPORTING FORM
For VOLUNTARY reporting of Adverse Drug Reaction by Healthcare Professionals
INDIAN PHARMACOPOEIA COMMISSION(National Coordination Centre-Pharmacovigilance Programme of India)
Ministry of Health & Family Welfare, Government of India Sector-23, Raj Nagar, Ghaziabad-201002

A. PATIENT INFORMATION Reg. No. /IPD No. /OPD No. /CR No. :

1. Patient Initials 2. Age at the time of 3. M □ F □ Other □ AMC Report No. :

Event or Date of Birth
_________ ______________ 4. Weight________Kgs Worldwide Unique No. :
B. SUSPECTED ADVERSE REACTION 12. Relevant tests/ laboratory data with dates
5. Event/Reaction start date (dd/mm/yyyy)
6. Event/Reaction stop date (dd/mm/yyyy)
6 (A). Onset Lag Time
7. Describe Event/Reaction with treatment details, if any 13. Relevant medical/medication history (e.g. allergies, race,
pregnancy, smoking, alcohol use, hepatic/renal dysfunction,
past surgery etc.)

14. Seriousness of the reaction: No □ if Yes □(please tick

anyone)
□ Death (dd/mm/yyyy) □ Congenital-anomaly
□ Life threatening □ Disability
□Hospitalization/Prolonged □ Other Medically important
15. Outcomes
□ Recovered □ Recovering □ Not recovered
□ Fatal □ Recovered with sequelae □ Unknown
C. SUSPECTED MEDICATION(S)
Exp. Date Frequency Therapy dates
8. Name Manufacturer Batch No. Dose Route Causality
S.No (if (OD, BD Date Indication
(Brand/Generic) (if known) / Lot No. used used Assessment
known) etc.) Date started stopped
i
ii
iii
iv*
S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Drug Dose Dose not Not
per C withdrawn Dose increased reduced changed applicable
Unknown Yes No Effect unknown Dose (if reintroduced)
i
ii
iii
iv
11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
S.No Name (Brand/Generic) Dose Route used Frequency (OD, Therapy dates Indication
used BD, etc.) Date Date
started stopped
i
ii
iii*
Additional Information: D. REPORTER DETAILS
16. Name and Professional Address:________________________
_____________________________________________________
Pin:____________E-mail_________________________________
Tel. No. (with STD code)__________________________________
Occupation:___________________ Signature:________________

17. Date of this report (dd/mm/yyyy):

Sig. and Name of Receiver-
Confidentiality: The patient’s identity is held in strict confidence and protected to the fullest extent. Submission of a report does not
constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction. Submission
of an ADR report does not have any legal implication on the reporter.
*use separate page for more information
 Scales for Causality Assessment of ADR

I] Naranjo Adverse Drug Reaction Probability Scale

Sr. Do not
Questions Yes No Score
no. know
Are there previous conclusive reports on this
1 +1 0 0
reaction?
Did the adverse event appear after the suspected
2 +2 -1 0
drug was administered?
Did the adverse reaction improve when the drug
3 was discontinued or a specific antagonist was +1 0 0
administered?
Did the adverse event reappear when the drug was
4 +2 -1 0
re‐administered?
Are there alternative causes (other than the drug)
5 -1 +2 0
that could on their own have caused the reaction?
Did the reaction reappear when a placebo was
6 -1 +1 0
given?
Was the drug detected in blood (or other fluids) in
7 +1 0 0
concentrations known to be toxic?
Was the reaction more severe when the dose was
8 increased or less severe when the dose was +1 0 0
decreased?
Did the patient have a similar reaction to the same
9 +1 0 0
or similar drugs in any previous exposure?
Was the adverse event confirmed by any objective
10 +1 0 0
evidence?

Total Score

Scoring

• ≥ 9 = Definite ADR
• 5-8 = Probable ADR
• 1-4 = Possible ADR
• 0 = Doubtful ADR
II] WHO-UMC causality assessment criteria

Causality term Assessment criteria*

• Event or laboratory test abnormality, with plausible time

relationship to drug intake
• Cannot be explained by disease or other drugs
• Response to withdrawal plausible (pharmacologically,
pathologically)
Certain
• Event definitive pharmacologically or
phenomenologically (i.e. an objective and specific
medical disorder or a recognized pharmacological
phenomenon)
• Rechallenge satisfactory, if necessary
• Event or laboratory test abnormality, with reasonable
time relationship to drug intake
Probable /
• Unlikely to be attributed to disease or other drugs
Likely
• Response to withdrawal clinically reasonable
• Rechallenge not required
• Event or laboratory test abnormality, with reasonable
time relationship to drug intake
Possible • Could also be explained by disease or other drugs
• Information on drug withdrawal may be lacking or
unclear
• Event or laboratory test abnormality, with a time to drug
intake that makes a relationship improbable (but not
Unlikely
impossible)
• Disease or other drugs provide plausible explanations

• Event or laboratory test abnormality

Conditional /
• More data for proper assessment needed, or
Unclassified
• Additional data under examination

• Report suggesting an adverse reaction

Unassessable / • Cannot be judged because information is insufficient or
Unclassifiable contradictory
• Data cannot be supplemented or verified

*All points should be reasonably complied with