Published: 5 March 2026

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Gathering knowledge from adverse reaction reports: March 2026

Published: 5 March 2026
Prescriber Update 47(1): 12–13
March 2026

Adverse drug reaction (ADR) reporting is an important component of medicine safety monitoring. Case reports can highlight significant safety issues with medicines and how they are used.

The table below presents a selection of recent informative cases reported to the New Zealand Pharmacovigilance Database.

Case detailsa,b Reaction description and data sheet informationb,c
Report ID: 163830
Age:
39 years
Gender:
Female
Medicine(s):
Codeine
Reaction(s):
Biliary spasm
The patient experienced a possible biliary duct spasm (swelling, itching, pain, yellow coloured eyes and abnormal liver function tests) after taking codeine.
Biliary spasm is listed in the Codeine Phosphate data sheet.
Report ID: 164379
Age:
6 years
Gender:
Male
Medicine(s):
Midazolam
Reaction(s):
Agitated, aggression, violent behaviour
Following administration of midazolam, the child became aggressive, violent and agitated.
The Midazolam Injection data sheet states that paradoxical reactions (including agitation, anger, rage reaction, aggressiveness and assault) have been reported, particularly among children and the elderly.
Report ID: 164390
Age:
21 years
Gender:
Not reported
Medicine(s):
Ibuprofen
Reaction(s):
Toxic epidermal necrolysis (TEN)
Two days after taking ibuprofen, the patient developed a widespread blanching maculopapular rash plus fever, sore eyes, photophobia, tachycardia, hypotension and airway sloughing. The patient was diagnosed with TEN.
TEN is listed as a very rare ADR in the Ibuprofen SR BNM and Ibuprofen (Relieve) data sheets.
Report ID: 165878
Age:
15 years
Gender:
Female
Medicine(s):
Atomoxetine
Reaction(s):
Raynaud’s phenomenon
The patient experienced Raynaud’s phenomenon during treatment with atomoxetine.
Raynaud’s phenomenon is listed as a very rare ADR in the Apo-Atomoxetine data sheet.

Notes:

  1. Only the medicines suspected to have caused the reaction are listed in the table.
  2. The reactions listed in the ‘Case details’ column are coded according to the Medical Dictionary for Regulatory Activities (MedDRA), an internationally used set of standardised terms relating to medical conditions, medicines and medical devices. The reactions listed in the ‘Reaction description’ column are based on what was reported, and do not always match the MedDRA term exactly.
  3. If the suspect medicine’s brand name is not described in the ADR report, only the data sheet for the funded medicine is included in the table.

Information about reported suspected adverse reactions is available on the Medsafe website using the Suspected Medicines Adverse Reaction Search (SMARS).

By selecting the ingredient of a medicine or vaccine, you can find out:

  • the number of reports and suspected adverse reactions for that ingredient. The suspected reactions are grouped by body system or organs (Summary report)
  • single case reports, listing the medicines and/or vaccines involved that contain the ingredient and the suspected adverse reactions (Detail report).
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