Reporting Adverse Drug Effects



Reporting Adverse Drug Reactions

What to report? (you do not need to be certain, just suspicious!)

Adverse Drug Reactions Advisory Committee (ADRAC) encourages the reporting of all suspected adverse reactions to medicines, including vaccines, OTC medicines, herbal, traditional or alternative remedies. ADRAC particularly requests reports of:

ALL suspected reactions to new drugs

ALL suspected drug interactions

Suspected reactions causing:

Death

Admission to hospital or prolongation of hospitalisation

Increased investigations or treatment

Birth defects

Blue cards

Reports of suspected adverse drug reactions are best made by using a prepaid reporting form ("blue card") which is available from the :

or Adverse Drug Reactions Unit (02 6232 8744)

Reports can also be submitted electronically by email: ADR.Reports@.au or via the website

TGA Office of Medicines Safety Monitoring

Email: adrac@.au

Phone: 1800 044 114

Fax: 02 6232 8392

Related information

Adverse drug reactions: frequently asked questions

Adverse drug reactions: what to report



Adverse drug reactions: what information to include in a report

Adverse drug reactions: what happens to a report

Safety monitoring guidelines



Adverse Drug Reactions Advisory Committee (ADRAC)

Reference

Therapeutic Goods Administration. (2008). Reporting adverse drug reactions.

Australian Adverse Drug Reactions Bulletin, 27(5), p. 20

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