ADVERSE DRUG REACTION REPORTING FORM - TizigPharma | Shaping the future of healthcare with innovative, high-quality, and cost-effective solutions.

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

Case Identification Fields

Case Type

Reg. No./IPD No./OPD No./CR No

Section A. Patient Information

Patient Name *

Age at onset of reaction *

Date of Birth *

Weight (in Kg) *

Height (in cm) *

Section B. Suspected Adverse Reaction

Reaction/Event Onset Date *

Reaction/Event Onset Time *

Hours

Minutes

AM/PM

Reaction/Event End Date *

Reaction/Event End Time

Hours

Minutes

AM/PM

Duration

Describe Event/Reaction management

Relevant medical/drug history

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

Section C. Suspected Medication(s)

Medication i

S. No

Name (Brand/Generic) *

Manufacturer (if known)

Batch No./ LotNo.

Expiry Date

Dose

Route

Indication

Causality Assessment PerformedYesNo

Section D. Action Taken / Reintroduction

Reaction reappeared after reintroduction of suspected medication

Reaction reappeared after reintroductionYesNoEffect unknown

Dose (if reintroduced

Section E. Concomitant Medical Products

Concomitant medical product including self-medication add herbal remedies with therapy dates (Exclude those used to treat reaction)

Name (Brand / Generic)

Dose

Route

Frequency

Start Date

Stop Date

Indication

Do you suspect quality issues (including falsified) on the products?YesNo

If Yes, Explain briefly :

Section F. Reporter Details

Name

Street Address

Apartment, suite, etc

City

State/Province

ZIP / Postal code

Country

Email Address

Phone

Organization

Signature

Upload file

No file chosen

Report Date

NRA Section Fields “To be filled by NRA (National Regulatory Authority)”.

Received via

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.