Published: 5 June 2025

Publications

Gathering knowledge from adverse reaction reports: June 2025

Published: 5 June 2025
Prescriber Update 46(2): 31–32
June 2025

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: 154372 Age: 71 years Gender: Male Medicine(s): Zoledronic acid Reaction(s): Hypophosphataemia	Following a zoledronic acid infusion, the patient developed hypophosphataemia.
	There is a warning about hypophosphataemia in the Aclasta data sheet.
Report ID: 160125 Age: not reported Gender: Male Medicine(s): Omeprazole Reaction(s): Anger, mood changes	After starting omeprazole for the first time, the patient experienced mood changes.
	The Omeprazole Actavis data sheet lists agitation, aggression, confusion, depression and hallucinations as rare ADRs. See also the March 2024 Prescriber Update article: Unexplained mood and behavioural changes – could it be a side effect?
Report ID: 160432 Age: 56 years Gender: Male Medicine(s): Chlorpromazine Reaction(s): Cholestatic hepatitis	Ten days after completing a course of chlorpromazine, the person experienced reduced appetite, right upper quadrant abdominal discomfort, constipation, jaundice, fevers and night sweats. He was diagnosed with acute cholestatic hepatitis.
	The Largactil data sheet has a warning about severe liver toxicity, which can be fatal. Advise patients or caregivers to immediately seek medical attention for signs and symptoms of liver injury.
Report ID: 160509 Age: 94 years Gender: Male Medicine(s): Testosterone Reaction(s): Pulmonary oil microembolism, disorientation, unresponsive to stimuli, syncope, cyanosis, chest pain, cough	Immediately after receiving a testosterone injection, the patient experienced symptoms suggestive of a pulmonary oil microembolism.
	The Reandron data sheet states that pulmonary microembolism of oily solutions can in rare cases lead to signs and symptoms such as cough, dyspnoea, malaise, hyperhidrosis, chest pain, dizziness, paraesthesia or syncope. These reactions may occur during or immediately after the injections and are reversible.
Report ID: 161091 Age: 31 years Gender: Female Medicine(s): Rivaroxaban Reaction(s): Vaginal haemorrhage	One day after starting rivaroxaban, the person developed uncontrollable vaginal bleeding.
	Urogenital tract haemorrhage (including haematuria and menorrhagia) is listed in the Xarelto 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).