Version-1.

3
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 lIndia)
Ministry of Health &Family Welfare, Government of lndia Sector-23, Raj Nagar, Ghaziabad-201002

A PATIENT INFORMATION Reg. No. /IPD No. /OPD No. /CR No. Su38.
1. Patient Initials 2. Age at the time of 3. MaFO Other o AMC Report No. :
Event or Date of Birth
4. Weight 66 Kgs Worldwide Unique No. :
B.SUSPECTED ADVERSE REACTION 12. Relevant tests/ laboratory data with dates
5. Event/Reaction start date (dd/mm/yyyy) LET.
6. Event/Reaction stop date (dd/mm/yyyy)
2s/ lo (2t.
6 (A). Onset Lag Time
7. Describe Event/Reaction with treatment details, if any 13. Relevant medical/medication history (e.g. allergies, race,
Patent cOag ¯oguesed wis pulmonay TR on olte/2) pregnancy,smoking, alcohol use, hepatic/rena! dysfunction,
yway pt on 1st Bne anti -T8 ceugs CFDC). past surgery etc.)
agscust oeat alc 3ince Ags.
s days Patse came wth lo uausea, vomtng,
Passtng cark qellao Calocued usne, yellowisl 14.Seriousness of the reaction: No fYes Glplease tick
anyone)
Sndued epatero SIHY days tee coy no ighs Death( t ) O Congenitai-anomaly
cOUe Stopped. atu s O Life threatening D Disability
st jaundie, er as moamal. patfent cws OOther Medically imoortant
Selaltenged cwitt, Rifampio'n, sowald, Pyaina DHospitalization/Prolonged
mide.
Patin way uaged wnytwthideied 8 emo ved. 15. 0utcomes
eeay tttwed anttRecovered O Recovering D Not recovered

OFatal ORecovered with sequelae O Unknown

C SUSPECTED MEDICATION(S)
Exp. Date Frequency Therapy dates
8. Name ManufacturerBatch 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
FDC NM, E) XDC Pham 3490y lo (222. olo12125l lo2ulmoag TB. CRuasn
iii

S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Dose Dose not Not
Drug Dose increased Unknown Yes No Effect unknown Dose (if reintroduced)
per Cwithdrawn reduced changed applicable
ct.
-=

11,Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
Dose Route used Frequency (0D, Therapy dates Indication
S.No Name (Brand/Generic)
used BD,etc.) Date Date
started stopped

ii
iii
Additional Information: D.REPORTER DETAILS
16.Name and Professional Address: D Rau
BMH chiteadaga.
Pin: E-mail -
Tel. No. (with STD code) 9 298?f99
Occupation: DoN Signature:

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

Sig. and Name of Receiver
Contidentiality: The patient's identíty is held in strict confidence and protected to the fullest extent. Sübmission of areport 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
 ysesmet (wto -UMe caa)
Caus a
uFDe CUNREi 2) way
induud upotosogdy" wth uespe 5
sesment Beale.
asesed Ctan WO OMe cauaiy
stesa. Tayune
Te mpaal aso'aton
ys.
natve trplauaton, No.

Deuhallng
eslatenge.
 Version-1.3

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

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

Reg. No. /IPD No. /OPD No. /CR No.: SOO8.

À. PATIENT INFORMATION
2. Age at the time of 3. M FO Other o AMC Report No.
1. Patient Initials Event or Date of Birth
4. Weight s : Kgs Worldwide Unique No. :
12. Relevant tests/ laboratory data with dates
B. SUSPECTEDADVERSE REACTION
S. Event/Reaction start date (dd/mm/yyy) wIN.
6. Event/Reaction stop date (dd/mm/yyyv) Ul.
6 (A). Onset Lag Time
13. Relevant medical/medication history (e.g. allergies, race,
7. Describe Event/Reaction with treatment details, if any
pregnancy, smoking, alcohol use, hepatic/renal dysfunction,
Patient paesnted wte aet ouset aaslh past surgery etc.)
| d y yhuating Sdays ayta ine'sen dag UlN.

amiHoing TMX- $M, te p t t dveloped a 14. Seriousness of the reaction: No Oif Yes eplease
tick
PLesgeive, ttsely peutt Lash speeading om anyone)
taunk y coveeing most He body nduding Jase o Death(nvde ) OCongenital-anomaly
OLife threatening ODisability
He
solleny adheent Ups, diy'uty baeating ospitalization/Prolonged OOther Medically important

3upeerd 15.Outcomes
tulay Epiphie g mhyl peedatseene to4, naema. ONot recovered
eRecovered ORecovering
a wle Pattet beearne DRecovered with sequelae O Unknown
D Fatal

C:SUSPECTED MEDICATION(S)
Exp. Date Frequency Therapy dates Causality
|S.No
8. Name ManufacturerBatch No. (if
Dose Route
(OD, BD Date Indication Assessment
(Brand/Generic) (if known)/Lot No. known) used used Date started
etc.) stopped
iTMP-3MXO C pla|34 DUy tol 2022. elteal abey Possible.!

iv
S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Dose Dose not Not Effect unknown Dose (if reintroduced)
Drug Dose increased Unknown Yes No
per C|withdrawn reduced changed lapplicable

ii

11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
Name (Brand/Generic) Dose Route used Frequency (0D, Therapy dates Indication
S.No
used BD, etc.) Date Date
started stopped

Additional Information: D. REPORTER DETAILS

16. Name and Professional Address: DA. Naween.

Pin: E-mail
Tel. No. (with STD code) uee 1899.
Occupation: Douo Signature:

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

Sig. and Name of Receiver
Confidentiality: The patient'sidentity is'held in strict confidence and protected to théfullest extent. Submission of a report does not
Constitute an admission that medical personnel or manufaturer 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
Causasy Assesment (wHo -Ume

The cauj al'y as1es3 ment Jer ta suious adueyse tvet of supeved
Posibl
WHO-Ume cauyoty sement sease.

Caitea

Tempaa s0atton yos.

phamaoto g'cat pdaufbiaM
A nattve lataton. keatn ttaud aya 2days
ae jood).
Deealleng. Nat appleable
Raclalng.
 Version-1.3

SUSPECTED ADVERSEDRUG REACTION REPORTING FORM

For VoLUNTARY reporting of Adverse Drug Reaction by Healthcare Professionals
INDIAN PHARMACOPOEIA COMMISsION(National Coordination Centre-Pharmacovigilance Programme of lndia)
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. SS22
1. Patient Initials 2. Age at the time of 3. M Fo Other o AMC Report No.
8. Event or Date of Birth
35 yy 4. Weight 24, Kgs Worldwide Unique No. :
B. SUSPECTED ADVERSE REACTION 12. Relevant tests/ laboratory data with dates
5. Event/Reaction start date (dd/mm/yyyy) Ul.
6. Event/Reaction stop date (dd/mm/yyyy)
lGl2go20
6 (A). Onset Lag Time
7. Describe Event/Reaction with treatment details, if any 13. Relevant medical/medication history (e.g. allergies, race,
Pottent oas giien i cejteaxone gLV Jaq orz past
pregnancy, smaking, alcohol use, hepatic/renal dystunction,
surgery etc.)
n lol9|220 patitt devloped ituing No ustot of 3imilau Cormplai
uithin yeo minuy of inyuiou. pattet Uas 14. Seriousness of the reaction: No if Yes (please tick
anyone)
O Death(ný) O Congenital-anomaly
OLife threatening O Disability
Cegejarone cway wtth deawn, Keplaced wte OHospitalization/Prolonged OOther Medically important
Tåb. Niherteatoin Somg pattent eco veee ol 15. Outcomes
kecovered O Recovering O Not recovered
O Fatal ORecovered with sequelae Unknown
CSUSPECTEDMEDICATION(S)
ManufacturerBatch No. Exp.(ifDate
Frequency Therapy dates
8. Name Dose Route
Indication
Causality
S.No (OD, BD Date
(Brand/Generic) (if known)/ Lot No. known) used used Date started stopped Assessment
etc.)
Cytiadne BN phau. boo sER to 2022 2g. VLT. Pobable.

iv*

S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Dose Dose not Not
Drug Dose increased Unknown Yes No Effect unknown Dose (if reintroduced)
per Cwithdrawn reduced changed applicable
i

iv
11. Concomitant medical productincluding self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
Route used Frequency (0D, Therapy dates Indication
S.No Name (Brand/Generic) Dose
used BD, etc.) Date Date
started stopped

Additional Information: D. REPORTER DETAILS

16. Name and Professional Address: D Peav,
BMeR. eutaduga.
Pin: E-mail
Tel. No. (with STD code) ee k 119
Occupation: decree Signature:_
17. Date of this report (dd/mm/yyyy):
Sig. and Name of Receiver
ConfideDtiality: The patient'sidentity is heldin strict confidenceand protected to the fullest extent. Submission of areport does not
constitute an admíssion 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
Causoity tssesment Cwpo - UMe ceiyea).
non-3 ouy adveye eve
The cowaly asusmet Jay tte
wtth awp

temanone way aysed

aysment

Caltea.

Tmpasal assorattn,
pleamaentsqal plauwiity.
No.
Atnative planati.

Deelatteng Not done

Raslalleng
 Version-1.3

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

22
A. PATIENT INFORMATION Reg. No. /IPD No. /OPD No. /CRNo. :
2. Age at the time of 3. MO Fother o AMC Report No.
1. Patient Initials
Event or Date of Birth
4. Weight Se Kgs Worldwide Unique No.:
B. SUSPECTED ADVERSE REACTION 12. Relevant tests/ laboratory data with dates
5. Event/Reactionstart date (dd/mm/yyy) r 2 0 20
6. Event/Reaction stop date (dd/mm/yyyy)
6 (A). Onset Lag Time
2tyl22020
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,
lahant a s b e e n Iakfug
hoo epi past surgery etc.)
7eb phenyle t00ma,thnce dou'ly Pro
22|ofl2020 - gtirdays hent deltlopcl.
enylaenwaleusrahesuorcuteneows ercolns, 14. Seriousness of the reaction: No O if Yespolease tick
mutipl blutew a<|echre faereck uppn
agntaile Seven anyone)
nt fahent
|ohnaen mas
4{nelrne,neryen wessiopo Death( 7 ) OCongenitai-anomaly
replaud ona. tub: RrtmSoomg OLife threatening ODisability
Hospitalization/Prolonged O Other Medically important

wasoschetgegn,24 2020 yAanHepilephe 15. Outcomes

mdca hevsl wos adsed vP o ter folow Recovered O Recovering O Not recovered
O Fatal O Recovered with sequelae O Unknown
CSUSPECTED MEDICATION(S)
Exp. Date |Frequency Therapy dates
S.No
8. Name ManufacturerBatch No. (if
Dose Route
(OD, BD Indication
Causality
Date
(Brand/Generic) (if known)/Lot No. used Used Date started Assessment
known) etc.) stopped
i Vhentom DPR Pharm 666Rlol20210Cngl orreTD 2\Dl20 |S]2/20|Epicpy hrobable
iv*
S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as
Drug Dose |Dose not Not
Dose increased Unknown Yes No Effect unknown Dose (if reintroduced)
per Cwithdrawn reduced changed applicable

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,
used
Therapy dates Indication
BD, etc.) Date Date
started stopped

Additional Information: D. REPORTER DETAILS

16. Name and Professional Address:Dr A hok
Pin:
BMHIChiadwqC
E-mail
Tel. No. (with STD code)622 yu49
Occupation: DoctY Signature:
17. Date of this report
Sig. and Name of Receiver (dd/mm/yyyy):
Castdantiality-The patient's identity is
held in strict contidence and protected to the
constitute an admission that medical personnel or manuracturer fullest extent. Submission of a report does not.
or the product caused or contributed to the
of an ADR report does not have any legal implication on the reporter. reaction. Submission.
*use separate page for more information
 plaiuY
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 *use of Information:
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Name
S.No Cwithdrawnper
iv |asS.No iv* S.No
constitute
Confidentiality: 11. ii MEDICATION(S)
SUSPECTED C 7. B.Patient
an ivuico. wibn 6 6. S. Initials
INFORMATION
PATIENT
1. A.
Concomitant 9.
|meaaeypoa O Describe
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at
wiheun nuleonh hhg (dd/mm/yvv)
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any reduced hent omtreatment tinme
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product Occupation:
PeetTY Tel. with
10.1s02\20|s
SOEe (OD,BD
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RMcHehihodweoA Date and Name etc.) of
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O 15. REACTION
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past
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Name of (with threatening
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Lif O 12. Report Reaction
and started Date Recovered anyone)o 14.
caused this Date DeatSeriousness
h Relevant Relevant Centre-Pharmacovigilance
Sector-23,
reappeared No.
of
report STDProfessional dates started
fullest Therapy
dates Therapy
dates (:) /IPD by
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tests/ Raj
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REPORTING
after stopped Recovering
O O the of /OPD
Address: Date Recovered alcohol laboratory No.
G those unknownDose
Effect(if
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No.
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Programme
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to used data
22 with
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 Versinn13

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

APATIENTINFORMATION Reg. No. /PD No. /OPDNo. /CR No.:G6 22

1
Pajent Initials 2. Age at the time of 3. M FO Other o AMC Report No.
Even,u o
B.SUSPECTED ADVER$E REACTION
or Date of Birth
4. Weight 6 Kgs Worldwide Unique No. :
12. Relevant tests/ laboratory data with dates
5. Event/Reaction start date
(dd/mm/yyvy)
6. Event/Reaction stop date (dd/mm/yyyy)
6 (A). Onset Lag Time
7. Describe Event/Reaction with treatment 13. Relevant medical/medication history (e.g. allergies, race,
details, if any
pregnancy, smoking, alcohol use, hepatic/rena! dysfunction,
past surgery etc.)
wao put Cop ariapa20le y0mgmorning
bejre fooo Poihent came to topilalnort douf
14. Seriousness of the reaction: NgÁ if Yes D(please tick
fahent uwoLslolel bo top ap fentapral hent anyone)
CeNMon-eluast
Tob weo putr la O Death(d ) OCongenita'-anomaly
Compliley wteun evt day O Life threatening ODisability
OHospitalization/Prolonged O Other Medically important
15. Outcomes

L Recovered ORecovering ONot recovered

OFatal O Recovered with sequelae O Unknown
C. SUSPECTED MEDICATION(S)
Exp. Date Frequency Therapy dates
8. Name ManufacturerBatch No. (it
Dose Route Causality
|S.No (0D, BD Date Indication
(Brand/Generic) (if known) |/Lot No. known) used used
etc.)
Date started| Assessment
stopped
aha Probate
S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Drug Dose Dose not Not
Dose increased Unknown Yes No Effect unknown Dose (if reintroduced)
per C|withdrawn reduced changed lapplicable

ii

ifi

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 (0D, Therapy dates Indication
used BD, etc.) Date Date
started stopped
ii

Additional Information: D. REPORTER DETAILS

16. Name and Professional Address: Pr M
Pin: E-mail
Tel. No. (with STD code) 44224L99
Occupation: portY Signature: ALN
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 areport does not
constitute an admissionnotthathavemedical personnel or manufacturer or the product caused or contributed to thereaction. Submision
any legal implication on the rporter,
of an ADR report does
*use separate page for more information
 Casa yanenmntl wHo-UMC 'teva)
sern mon
swelnq of{ fad, eleing al duer keu body witea respoct to fantopre2ele
was ened rola eon wHO-UME Caus Uy
amenment 1coal
uitea lneno
Temporl asoudhon Yes
Phamatogat pianitiiy Ves
xplanahon No

pachalteg |Not aplicate

Rechaleng ot done