> The spontaneous case was reported by a physician from ITALY and concerns a male patient who

experienced a serious adverse drug reaction of massive epistaxis associated with Acetyl salicyclic acid

> Patient medical history was not reported

> Patient experienced adverse event of Anaphylactic reaction of drug with seriousness criteria of
unknown

> Outcome of event Anaphylatic reaction to drug was reported as unknown

> This spontaneous case was reported by a physician from US(united state) and concerns 67 years old
female patient who experienced adverse drug reaction of massive epistaxis associated with AMLODIPINE

> Patient medical history includes Type 2 diabetes mellitus with hypertension start date was not
reported and continuing at the time of reporting..concomitant medicate include Hydrochlorothiazide

> Patient received Amlodipine on an unknown date and month .Patient experienced adverse event of
drug eruption Lichen planus-like with no seriousness criteria

> Drug was with drawn with respect to event .

> Outcome of event drug eruption Lichen planus -like was reported as recovering/resolving

> This spontaneous case was reported by physician from US concerns a 12 years old female patient
experienced a serious adverse reaction of massive eoistaxis associated with Amlodipine with 300mg

> Patient medical history was not reported

> Patient recieved recovering/resolving outcomes as an unknown date and month .Patient experienced
adverse event of High cardiac output state , Anuric renal failure ,Multi-organ failure, Intentional
overdose, Acute respiratory distress syndrome , Vasodilatory shock with seriousness criteria of life
threat,hospitalization and other.

> Action taken was not applicable .

> Outcome of event high cardiac output state anuric renal failure multi-organ failure,condition worsened,
International overdose, Acute respiratory distress syndrome vasodilatory shock was reported as
recovering/resolving
 Version 1.4

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

For VOLUNTARY reporting of ADRs 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
PvPI Helpline (Toll Free) :1800-180-3024 (9:00 AM to 5:30 PM, Monday-Friday)

Initial Case  Follow-up Case  FOR AMC / NCC USE ONLY

A. PATIENT INFORMATION * Reg. No. / IPD No. / OPD No. / CR No. : 570200002
1. Patient Initials: Y 2. Age or date of birth: 07/11/2002 AMC Report No. : 512
3. Gender: M  F  Other  4.Weight (in Kg.) 80 Worldwide Unique No. : 5
12. Relevant investigations with dates :
B. SUSPECTED ADVERSE REACTION *
5. Event / Reaction start date (dd/mm/yyyy) 15/7/2023
6. Event / Reaction stop date (dd/mm/yyyy) 15/12/2023
7. Describe Event/Reaction management with details , if any

I received Asprin drug rash body,itchy,felt unwell, and

headach 13. Relevant medical / medication history (e.g. allergies,
pregnancy, addiction, hepatic, renal dysfunction etc.)

allergic and life threat

14. Seriousness of the reaction : No  if Yes  (please tick anyone)

 Death (dd/mm/yyyy)  Congenital-anomaly
 Life threatening  Disability
 Hospitalization-Initial/Prolonged  Other Medically important
15. Outcome:
 Recovered  Recovering  Not Recovered
 Fatal  Recovered with sequelae  Unknown
C. SUSPECTED MEDICATION(S) *
S. 8. Manufactu Batch No. Expiry Dose Route Frequency Therapy Dates Indication Causality
No. Name rer / Date Date Date Assessment
(Brand/ (if known) Lot (if Started Stopped
Generic) No. known)
i ARTHOQULE 57020002 1 ORAL 1 2023 2023 ARTHOQULE RELATED

ii ASPRIN 71598411 1 ORAL 2 2023 2023 ASPRIN RELATED

iii
iv #
10. Reaction reappeared after reintroduction of
9. Action taken after reaction (please tick)
suspected medication (please tick)
S. Drug Dose Dose Dose not Not Unknown Yes No Effect Dose
No. withdrawn increased reduced changed applicable unknown (if re-
as introduced)
per C
i NA

ii NA

iii
iv
11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
Name Dose Route Frequency (OD, Therapy Dates Indication
S. No. (Brand / Generic) BD, etc.)
Date Started Date Stopped

i
ii
iii #
Additional Information : D. REPORTER DETAILS *
Allergic reaction due to overdoseing of drug YOGESH & V.P.O- SAGARPUR ,FARIDABAD,HARYANA
16. Name & Address : __________________ __________________________
______________________________________ __________________________
121004 [email protected]
Pin : __________ Email : ___________________________________________
8307007990
Contact No- : _______________________________
GRADUATE
Occupation : _______________________Signature : YOGESH
___________________
17. Date of this report (dd/mm/yyyy) : 15/07/2023
Signature and Name of Receiving Personnel :
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. Submiss ion of an
ADR report does not have any legal implication on the reporter.
# Use separate page for more information
* Mandatory Fields for suspected ADR Reporting Form
 ADVICE ABOUT REPORTING

A. What to report?

All adverse events should be reported

Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines & Herbal Products.

Report every serious adverse drug reactions. A reaction is serious when the patient outcome is :
 Death
 Life-threatening
 Hospitalization (initial or prolonged)
 Disability (significant, persistent or permanent)
 Congenital anomaly
 Report intervention to prevent permanent impairment or damage

NOTE : Serious/Adverse Event following immunization can also be reported in Serious AEFI case Notification
Form available on http://www.ipc.gov.in

B. Who can report?

All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurse etc.) can report adverse drug reactions

C. Where to report?
Duly filled in Suspected Adverse Drug Reaction Reporting Form can be sent to the nearest Adverse Drug Reaction Monitoring
Centre (AMC) or directly to the National Coordination Centre (NCC) for PvPI.

Call on Helpline (Toll Free) 1800 180 3024 to report ADRs or directly mail this filled form to [email protected]

A list of nationwide AMCs is available at : http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html

D.What happens to the submitted information?

 Information provided in this form is handled in strict confidence. The causality assessment is carried out at AMCs by using
WHO-UMC scale. The analyzed forms are forwarded to the NCC -PvPI through ADR database. Finally the data is analyzed
and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden.
 The reports are periodically reviewed by the NCC -PvPI. The information generated on the basis of these reports helps in
continuous assessment of the benefit-risk ratio of medicines.
 The Signal Review Panel of PvPI reviews the data and suggests any interventions that may be required.

E. Mandatory fields for suspected ADR Reporting Form ( *)

Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected medication(s) & reporter
information.

For Adverse Drug Reaction Reporting Tools

 E-mail : [email protected]
 PvPI Helpline (Toll Free) : 1800 180 3024 (9:00 AM to 5:30 PM, Monday-Friday)
 ADR Mobile App : “ADRPvPI”