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Causality: well established
Causality assessment · Causality: well established
Efavirenz and Depression / neuropsychiatric effects: 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.
Efavirenz ↔ Depression / neuropsychiatric effects
n=461 co-reports · PRR 3.8 · ROR 3.9
Efavirenz, a non-nucleoside HIV drug, commonly causes central-nervous-system effects — vivid dreams, dizziness, insomnia, and mood disturbance including depression — that often ease after the first weeks but can persist. The drug carries labelled warnings about psychiatric symptoms and suicidal thinking. The 461 co-reports (PRR 3.8) reflect both the real effect and efavirenz's long-standing role in HIV regimens, especially in resource-limited settings.
Regulatory basis: efavirenz prescribing information (neuropsychiatric symptoms, depression, and suicidality warnings).
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Neuropsychiatric symptoms appear early in therapy and may ease or persist |
| Strength | partial | PRR 4 on a moderate co-report count |
| Consistency | met | Reproduced across HIV cohorts |
| Specificity | partial | A recognised efavirenz effect, less typical of other antiretrovirals |
| Biological gradient | partial | Partly dose-related |
| Plausibility | met | Central-nervous-system effects of the drug are the proposed mechanism |
| Coherence | met | Coheres with the labelled psychiatric warnings |
| Experiment | partial | Dechallenge (withdrawal/switch) usually improves symptoms; no randomized trial |
| Analogy | met | Analogous to neuropsychiatric effects of some other antiretrovirals |
This page's own qualitative read, not an automated/citation-gated assessment.
✗ No ClinicalTrials.gov results-posting trial in the top search hits for efavirenz captured depression as a coded event; the neuropsychiatric effects are identified through clinical reports and cohort data rather than a trial AE table.