Ketamine and Cystitis: is the FAERS signal real?
Ketamine ↔ Cystitis
Ketamine is an NMDA-receptor antagonist used for anaesthesia and, increasingly, treatment-resistant depression; with chronic recreational use it causes profound ulcerative cystitis and urinary-tract damage (ketamine-induced cystitis, 83 co-reports here, PRR 11.3). The injury is dose- and duration-dependent, progressive, and can persist after cessation, sometimes requiring surgery.
Regulatory basis: ketamine prescribing information — urinary-tract effects with chronic use; ketamine-cystitis literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Cystitis after months of chronic use |
| Strength | met | PRR 11.3, moderate |
| Consistency | met | Reproduced across case series |
| Specificity | met | Fairly specific to ketamine |
| Biological gradient | met | Dose- and duration-dependent |
| Plausibility | met | Direct urothelial toxicity |
| Coherence | met | Fits the pharmacology |
| Experiment | n/a | Not a trial endpoint |
| Analogy | met | Analogous to other drug-induced cystitis |
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.
✓ Trial evidence found — A Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Adult Participants With Treatment-resistant Depression (NCT02493868)
| Adverse event | IND: Intranasal Esketamine + Oral AD (n=437) · OP: Intranasal Esketamine + Oral AD (n=455) · MA: Intranasal Esketamine + Oral AD (n=152) · MA: Oral AD + Intranasal Placebo (n=145) | |||
|---|---|---|---|---|
| Cholecystitis Acute | 0/437 | 1/455 | 0/152 | 0/145 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →