Notification form for adverse effect, adverse drug reaction or absence of expected
therapeutical effect of the medicinal drug
PHISICIAN or other person reporting ADR
Full name:
Job title and place of employment:
Office address :
Telephone number:
Data of information obtaining:
Traetment:  outpatient  inpatient  self-treatment
Report:  initial
 follow-up (data of initial ________ )
PATIENT INFORMATION
Initials:
№ of medical treatment record or patient record _________
Sex:  М
F
Age: _________ Weight (kg): __________
Pregnancy  Gestational age _____ weeks
Compromised liver function  yes  no  not known
Compromised kidney function  yes  no  not known
Allergy (specify the allergen):
MEDICINAL DRUG (MD) №1, suspected of causing ADR
International Nonproprietary Name
(INN)
Manufacturer
Indication
Trade
name
Country
Route of
administrat Single/ Daily dose
ion
Series number
Date of
treatment
initiation
/
Date of therapy
discontinuation
/
/
The dose
caused ADR
/
MEDICINAL DRUG (MD) №2, suspected of causing ADR
International Nonproprietary Name
(INN)
Manufacturer
Indication
Trade
name
Country
Route of
administrat Single/ Daily dose
ion
Series number
Date of
treatment
initiation
/
Date of therapy
discontinuation
/
/
The dose
caused ADR
/
MEDICINAL DRUG (MD) №3, suspected of causing ADR
International Nonproprietary Name
(INN)
Manufacturer
Indication
Trade
name
Country
Route of
administrat Single/ Daily dose
ion
Series number
Date of
treatment
initiation
/
Date of therapy
discontinuation
/
/
The dose
caused ADR
/
OTHER MEDICINAL DRUGS, taken within last 3 months, including MD administered by the patient
independently (in his discretion)
Indicate «NO», if the patient did not take other drugs
Date of
Date of
Route of
therapy
INN
TN
treatment
Indication
administration
discontinuati
initiation
on
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Description of ADR:
Date of onset
of ADR:
___/_____/___
__
Date of
resolution:
____/___
/______
Was withdrawal of MD associate with resolution of ADR?
applicable
 yes
 no  MD was not withdrawn  not
Was re-initiation of ADR observed after repeated administration of MD?  yes  no  MD was not administered
repeatedly  not applicable
Taken measures:
 No treatment
 Withdrawal of suspected MD
 Reduction of dose of suspected MD
 Withdrawal of concomitant treatment
 Pharmacological treatment
 Non-pharmacological treatment (including surgical
intervention)
 Other, specify ________________________________
Medical therapy of ADR (where appropriate)
Outcome:
 recovery without consequences
 state improvement
 state without changes
 recovery with consequences (specify)_____________
 death
 not known
 not applicable
Criterion of seriousness (specify, if applicable):
 death
 life-threatening condition
 hospitalization or its prolongation
 congenital malformations
 incapacity / disability
 not applicable
Relevant additional information
Data from clinical, laboratory, radiological investigations and autopsy, including determination of MD concentration in
the blood / tissues, if there are any, and they are associated with ADR (please indicate dates).
Concomitant diseases. Anamnestic data, suspected drug interactions.
For congenital abnormality specify all other MD taken during pregnancy and the date of last menstrual period. Please
attach additional pages if necessary.