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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Aripiprazole and Weight Increased: 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.
Aripiprazole ↔ Weight Increased
n=7,848 co-reports · PRR 6.3 · ROR 6.6
Aripiprazole is an atypical antipsychotic with partial D2 agonism. Weight increased is the expected pharmacological effect of its H1 and 5-HT2C receptor blockade, similar to other atypical antipsychotics. 423 co-reports (PRR 17.2) reflect a well-documented metabolic side effect. The label includes warnings about weight gain.
Label: aripiprazole PI (weight gain / metabolic changes). J. Clin Psychiatry 2019, PMID: 30968187.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 17.2 with 423 co-reports |
| Consistency | met | Reproduced across atypical antipsychotic class |
| Specificity | not established | Not specific (class-wide) |
| Biological gradient | met | Correlates with dose and duration |
| Plausibility | met | Known H1/5-HT2C mechanism |
| Coherence | met | Coherent with antipsychotic pharmacology |
| Experiment | met | Multiple RCTs confirm |
| Analogy | met | Other atypicals produce more weight gain |
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 Aripiprazole captured weight increased as a tracked adverse event in a usable structure. Weight gain is a standard metabolic AE endpoint in antipsychotic registration trials.