Published: 3 September 2026
Publications
Gathering knowledge from adverse reaction reports: September 2026
Published: 3 September 2026
Prescriber Update 47(3): 46–47
September 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: 166470 Age: 67 years Gender: Male Medicine(s): Felodipine Reaction(s): Gingival hypertrophy |
The patient experienced gum hyperplasia while taking felodipine. |
| The Felo ER data sheet lists gingival hyperplasia and gingivitis as ADRs. The gingival enlargement can be avoided or reversed by careful dental hygiene. | |
|
Report ID: 166844 Age: 78 years Gender: Male Medicine(s): Osimertinib Reaction(s): Congestive cardiac failure, pulmonary oedema, congestive cardiomyopathy, ejection fraction decreased |
During treatment with osimertinib, the patient developed pulmonary oedema due to congestive heart failure. They were found to have a dilated cardiomyopathy with severe left ventricular failure. |
| The Tagrisso data sheet describes cardiac adverse events, including congestive heart failure, ejection fraction decreased and pulmonary oedema, that are consistent with cardiac failure or cardiomyopathy. | |
|
Report ID: 167163 Age: 76 years Gender: Female Medicine(s): Zoledronic acid Reaction(s): Atrial fibrillation, heart rate increased, pruritus, malaise, pyrexia, pain, chills |
Immediately after receiving zoledronic acid infusion, the patient developed itchy skin. The next day, they became generally unwell with fever, chills and body aches plus an increased heart rate. They were subsequently diagnosed with atrial fibrillation. |
| Atrial fibrillation is listed as an uncommon ADR in the Zoledronic acid Viatris data sheet. Acute phase reactions (post-dose or flu-like symptoms) are also described and usually resolve within a few days. See also the March 2026 Prescriber Update article: Zoledronic acid: May be less tolerable for elderly patients | |
|
Report ID: 167284 Age: 63 years Gender: Female Medicine(s): Sertraline Reaction(s): Microscopic colitis |
Approximately four months after starting sertraline, the patient developed lymphocytic colitis (a subtype of microscopic colitis). |
| Microscopic colitis is listed as a postmarketing ADR in the Setrona data sheet. See also the December 2022 Prescriber Update article: Microscopic colitis - could it be caused by a medicine? | |
|
Report ID: 167417 Age: 39 years Gender: Female Medicine(s): Semaglutide Reaction(s): Cholecystitis |
Several months after starting semaglutide, the patient developed cholecystitis. |
| The Wegovy data sheet states that cholelithiasis was reported in 1.6% and led to cholecystitis in 0.6% of patients treated with semaglutide. | |
|
Report ID: 167685 Age: 45 years Gender: Female Medicine(s): Estradiol, progesterone Reaction(s): Pulmonary embolism, deep vein thrombosis |
The patient developed a pulmonary embolism and deep vein thrombosis while taking estradiol and progesterone. She had a history of deep vein thrombosis. |
| Estradot and Utrogestan are contraindicated in women with previous or current venous thromboembolism (ie, deep vein thrombosis, pulmonary embolism). |
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).
For help with searching, see the How to Search SMARS page.
