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Causality: well established
Causality assessment · Causality: well established
Acetazolamide and Metabolic acidosis: is the FAERS signal real?
A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.
Acetazolamide ↔ Metabolic acidosis
n=206 co-reports · PRR 23.1 · ROR 23.9
Acetazolamide inhibits carbonic anhydrase, causing bicarbonate loss in the urine and a hyperchloraemic metabolic acidosis — a direct, expected consequence of the mechanism (206 co-reports, PRR 23.1). It is used deliberately for this effect in some settings (altitude illness, metabolic alkalosis) and becomes a limiting toxicity at high doses or in renal impairment; paraesthesias, hypokalaemia, and nephrolithiasis commonly accompany it.
Regulatory basis: acetazolamide prescribing information — metabolic acidosis; carbonic-anhydrase-inhibitor pharmacology.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Acidosis develops within days |
| Strength | met | PRR 23.1, large |
| Consistency | met | Consistent across case series |
| Specificity | partial | Shared across carbonic-anhydrase inhibitors |
| Biological gradient | met | Dose-related |
| Plausibility | met | Direct consequence of bicarbonate loss |
| Coherence | met | Fits the mechanism exactly |
| Experiment | met | Acid-base change is measurable on protocol labs |
| Analogy | met | Analogous to topiramate-induced acidosis |
This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for acetazolamide captured metabolic acidosis as a tracked adverse event in a usable structure. Trials reported acetazolamide's acid-base effect through laboratory measures rather than a coded adverse-event table entry.