Online AE Reporting


SUSPECTED ADVERSE DRUG REACTION REPORTING FORM
For VOLUNTARY reporting of Adverse Drug Reactions by healthcare professionals

CDSCO
Central Drugs Standard Control Organization

Directorate General of Health Services,
Ministry of Health & Family Welfare, Government of India,
FDA Bhavan, ITO, Kotla Road, New Delhi
www.cdsco.nic.in

(AMC/ NCC Use only)
AMC Report No.
Worldwide Unique no.
 
A. Patient Information 12. Relevant tests / laboratory data with dates
1.Patient Initials 2. Age at time of Event
or date of birth
3. Sex (M/ F)
M F
4. Weight Kgs
   
B. Suspected Adverse Reaction  
5. Date of reaction stated (dd/mm/yyyy) 13. Other relevant history including pre-existing medical conditions
(e.g. allergies, race, pregnancy, smoking, alcohol use, hepatic/ renal dysfunction etc)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem  
 
  14. Seriousness of the reaction
  Death (dd/mm/yyy) Congenitial anomaly
  Life threatening Required intervention to prevent permanent impairment / damage
  Hospitalization-initial or prolonged
  Disability Other (specify)
   
  15. Outcomes
  Fatal Recovering
  Continuing Recovered
  Unknown Other (specify)
 
C. Suspected medication(s)
S.No 8. Name (brand and /or generic name) Manufacturer (if known) Batch No. / Lot No. (if known) Exp. Date
(if known)
Dose used Route used Frequency Therapy dates (if known give duration) Reason for use of prescribed for
Date started
Date stopped
 
i.
ii.
iii.
iv.
   
Sl.No 9. Reaction abated after drug stopped or dose reduced 10. Reaction reappeared after reintroduction
As per C
Yes No Unknown NA Reduced dose Yes No Unknown NA If reintroduced
dose
i.
ii.
iii.
iv.
 
11. Concomitant medical product including self-medication and herbal remedies with therapy dates (exclude those used to treat reaction) D. Reporter (see confidentiality section in first page)
16. Name and Professional Address :
Pin code : E-mail
Tel. No. (with STD code):  
Occupation Signature
     
17. Causality Assessment 18. Date of this report (dd/mm/yyyy)
  

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