Published: 4 September 2025
Publications
Gathering knowledge from adverse reaction reports: September 2025
Published: 4 September 2025
Prescriber Update 46(3): 51–52
September 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: 161822 Age: Elderly Gender: Male Medicine(s): Hyoscine Reaction(s): Hallucinations, paranoia, delusion, psychosis |
Soon after applying the Scopolamine patch, the patient experienced hallucinations, paranoia, psychosis and delusions. |
| The Scopolamine Transdermal System data sheet warns that the elderly may be at increased risk of adverse reactions due to scopolamine’s anticholinergic effects. This includes neuropsychiatric effects such as confusion and/or visual hallucinations. Use with caution in the elderly. Remove the patch immediately if these occur. | |
|
Report ID: 161925 Age: 83 years Gender: Female Medicine(s): Furosemide Reaction(s): Bullous pemphigoid |
The patient developed biopsy-confirmed bullous pemphigoid after starting furosemide. |
| The IPCA-Frusemide data sheet states that allergic reactions may occur, including bullous lesions and pemphigoid. | |
|
Report ID: 162075 Age: 65 years Gender: Female Medicine(s): Shingles vaccine Reaction(s): Guillain Barré syndrome |
The patient developed Guillain Barré syndrome after receiving the shingles vaccine. |
| The Shingrix data sheet warns that there is an increased risk of Guillain-Barré syndrome (GBS) following vaccination. GBS is listed as a very rare ADR. | |
|
Report ID: 162083 Age: Elderly Gender: Male Medicine(s): Simvastatin, itraconazole Reaction(s): Myositis, drug interaction |
Following the concurrent administration of simvastatin and itraconazole, the patient experienced myositis, indicating a drug interaction. |
| As stated in the Simvastatin Viatris and Itrazole data sheets, concomitant administration of these medicines is contraindicated. Itraconazole is a potent inhibitor of CYP3A4 and reduces elimination of simvastatin. This leads to an increased risk of simvastatin-related ADRs, such as myopathy, rhabdomyolysis and liver enzyme abnormalities. | |
|
Report ID: 162944 Age: 19 years Gender: Male Medicine(s): Isotretinoin Reaction(s): Achilles tendon pain, enthesopathy, stiffness |
Approximately two weeks after starting isotretinoin, the patient developed bilateral pain and stiffness at the insertion points of the Achilles tendon (enthesopathy). |
| Section 4.8 of the Oratane data sheet has information about musculoskeletal and connective tissue disorders, including tendonitis. |
Notes:
- Only the medicines suspected to have caused the reaction are listed in the table.
- 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.
- 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).
