Peripheral oedema after six weeks of amlodipine
A pharmacovigilance case for causality assessment: work out which drug is responsible, grade the reaction's severity and seriousness, and defend a causality category using the Naranjo probability scale.
Naranjo probability scale
- Framework
- Naranjo probability scale
- You decide
- Suspect drug, reaction, severity, seriousness, causality
The case
A 62-year-old woman attends a follow-up appointment for hypertension and type 2 diabetes. Her blood pressure is well controlled on amlodipine 5 mg once daily, which was started six weeks ago. She also takes metformin 500 mg twice daily for diabetes, and uses ibuprofen 400 mg occasionally for knee pain (about three times per week). She reports gradual swelling of both ankles that began two weeks ago, approximately six weeks after starting amlodipine. The swelling is worse in the evenings and improves slightly with elevation. There is no associated pain, redness, or shortness of breath. On examination, she has bilateral pitting oedema extending from the ankles to the mid-shin. Heart rate is regular, 72 bpm; blood pressure 132/80 mmHg; jugular venous pressure is not elevated; lung fields are clear. She has no proteinuria; serum creatinine is 80 µmol/L (eGFR 90 mL/min/1.73 m²); liver function tests are normal; natriuretic peptide is within normal limits. An echocardiogram shows normal left ventricular systolic function with no significant valve disease. She has no personal or family history of venous insufficiency. Ibuprofen was continued unchanged during the period. She was asked to stop amlodipine for a trial off-drug. Within two weeks, the swelling had completely resolved, with no change in the other medications. She was not rechallenged with amlodipine. Her hypertension is now managed with ramipril 5 mg daily.
What you are asked to do
- Identify which of the patient's drugs is the suspect, and say why the others are not.
- Name the reaction and grade its severity.
- Decide whether it is serious by regulatory criteria, which is not the same as severe.
- Assign a causality category under the Naranjo probability scale and justify it from the timeline, the dechallenge and the alternative causes.
- State the management and what should be reported.
The suspect drug and the graded answer are deliberately not on this page: working them out is the exercise.
Log in to assess "Peripheral oedema after six weeks of amlodipine"
A free account opens the trainer: name the suspect drug, grade the reaction and commit to a causality category, then see how your assessment compares and why.
Taught in
More like this
- Statin-induced myopathy after a dose increase in a 66-year-old woman
- Recurrent nocturnal hypoglycaemia after basal insulin increase and exercise programme
- OSCE station: Disclosure of a medication error: double insulin dose to a 70-year-old inpatient
- Prescribing case: Anaphylaxis to Intravenous Co-amoxiclav
- Profuse Diarrhoea and Fever in an 80-Year-Old After Antibiotic Therapy
- Prolonged hypoglycaemia in an 84-year-old man with chronic kidney disease
Educational content for students and clinicians in training. It does not replace professional judgement, local protocols or current prescribing information.