Acetazolamide-induced pulmonary oedema: A disproportionality analysis from the EudraVigilance database

Area of Science:

• Pharmacovigilance
• Clinical Pharmacology
• Drug Safety

Background:

• Pulmonary oedema is a serious adverse event.
• Acetazolamide is a medication with various clinical uses.
• A potential association between acetazolamide and pulmonary oedema has not been previously studied.

Purpose of the Study:

• To investigate a possible association between acetazolamide and pulmonary oedema.
• To detect a safety signal for acetazolamide-induced pulmonary oedema using EudraVigilance data.

Main Methods:

• A disproportionality analysis (case-noncase method) was performed.
• Reporting odds ratios (RORs) were calculated using data up to February 2024.
• Analysis included spontaneous adverse reaction cases from EudraVigilance and VigiBase®.

Main Results:

• A total of 38,275 pulmonary oedema cases were identified among over 11 million adverse reactions.
• Acetazolamide was implicated in 31 pulmonary oedema cases, with many occurring post-cataract surgery.
• Significant RORs (3.63 in EudraVigilance, 4.44 in VigiBase®) indicated a safety signal.
• Five positive rechallenge cases and six deaths were reported.

Conclusions:

• The study confirms a safety signal suggesting a risk of serious pulmonary oedema associated with acetazolamide.
• Findings highlight the need for increased awareness of this potential adverse drug reaction.
• Further research may be warranted to elucidate the mechanism and confirm the association.