REPORTING FORM FOR SUSPECTED ADVERSE

DRUG REACTION(S)
(Made under regulations 33, 36(1)(a), 38(1), and 46(1)

TMDA/DMC/CTP/F/012
Rev #: 3
Page 1 of 2

Note: Reporters and patients’ identity are held in strict confidence by TMDA and protected to the fullest extent of the law
I. Type of Report

Initial Follow up

II. Patient Information

Patient ID/ Initials.: ………………….Gender: Male Female If female; Pregnancy status Yes No
Weight(kg) ………... Height (m) ………...Full address …………………………. Telephone Number …………………………….
Date of Birth : .../…/… (dd-mm-yyyy) OR Age at onset: ......................
Medical History (Provide any relevant medical history (such as hepatic, renal, HIV), allergies, pregnancy, smoking, alcohol use, etc. and laboratory results
including dates (if done)
………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………………………
………………………………………………………………………………………………………………………………………………………………
III. Description of Suspected event(s)/reaction(s)

…………………………………………………………………………………………… Date of ADR Onset: / / Time of ADR Onset:

…………………………………………………………………………………………… Date ADR stopped: / /
……………………………………………………………………………………………..
Onset Latency (days/hours/min) ………………

IV. Details of suspected medical product

Name of suspected medicine Therapy Date Batch. No & Indication

(s) (Specify brandname or Generic name Route Dose and Expiry date (If (Reason foruse)
manufacturer if frequency Date stated Date Stopped known)
known)

1.

2.

Other medicines used at the same time and or one month before (including herbal medicines)
1.

2.

V. Severity of the ADR

Mild Moderate Severe Fatal Unknown

VI. Seriousness: Is the reaction serious? Yes No If yes; select and tick the reason for seriousness
Prolonged hospitalization Caused a congenital anomaly Disability Death Life threatening

VII. Action taken

Dose increased Dose reduced Drug changed Not applicable Unknown

VIII. Outcome
Recovering Recovered with sequalae Not recovered Death Unknown Recovered

IX. Therapeutic failure (provide information on medicine(s)/vaccine(s) showed lack of efficacy

X. Medication errors (provide detail of medication errors)

XI. Additional Information (Provide any other relevant additional information below)

Effective Date: 01/01/2022

 XII. Reporter Details
Name of reporter: Reporter Profession: Date of reporting:

Name and Address of reporter’s Institution: Email Address:

Contact /Tel No:

How to report? POSTAGE WILL BE PAID BY LICENCE

• Dully fill in the form as required

BUSINESS REPLY SERVICE LICENCE No. BRS 01
• Use a separate form for each patient
No postage stamp required if posted in Tanzania
• Report directly to TMDA through the following addresses:-

E-mail: adr@tmda.go.tz

Postage

Director General,
P. O. Box 1253,
Dodoma.
Fax: 22- 2450793
Phone: 22-2450512 / 2450751/ 0658 445222
Internet; http://www.tmda.go.tz

The ADR reporting form and the guidelines are also

available for downloading at http://www.tmda.go.tz

Thank you for your cooperation Reporting of suspected ADR has nothing to do with the reporter

Effective Date: 01/01/2022