Causality assessment · Causality: well established

Aripiprazole (antipsychotics) and Akathisia: is the FAERS signal real?

n=3,031 co-reports · PRR 49.1 · ROR 50.3

Aripiprazole (antipsychotics) side-effect profile All assessments See in the full list

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.

Causality: well established

Aripiprazole (antipsychotics) ↔ Akathisia

n=3,031 co-reports · PRR 49.1 · ROR 50.3

Aripiprazole, a widely used antipsychotic, commonly causes akathisia — an intense inner restlessness and urge to move that is distressing and a frequent reason patients stop treatment. It is a genuine, partly dose-related consequence of dopamine-receptor modulation, shared across antipsychotics but often prominent with aripiprazole. The very high FAERS count (3,031 co-reports, PRR 49.1) reflects both the real effect and the drug's extensive use in schizophrenia, bipolar disorder, and as an add-on antidepressant.

Regulatory basis: aripiprazole prescribing information (akathisia and extrapyramidal symptoms).

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Akathisia appears during treatment and improves after dose reduction or withdrawal
Strength	met	PRR 49 on a large co-report count
Consistency	met	Reproduced across antipsychotic trials
Specificity	partial	A class effect of antipsychotics, prominent with aripiprazole
Biological gradient	partial	Partly dose-related
Plausibility	met	Dopamine-receptor modulation is the mechanism
Coherence	met	Coheres with the labelled extrapyramidal-symptom advice
Experiment	met	A randomized trial recorded akathisia, at a higher rate on aripiprazole
Analogy	met	Analogous to akathisia from other antipsychotics

This page's own qualitative read, not an automated/citation-gated assessment.

✓ Trial evidence found — A Comparison Study of LY2140023 and Aripiprazole in Schizophrenia Patients (NCT01328093), N=942

Term (as recorded)	LY2140023-DB (n=511)	Aripiprazole-DB (n=161)	LY2140023-OL (n=270)
Akathisia — Nervous system disorders	13	12	2

Akathisia was recorded in 12 of 161 patients on aripiprazole versus 13 of 511 on the comparator in this randomized schizophrenia trial — a lower absolute count but a roughly three-fold higher rate, consistent with the drug's well-known restlessness signal. View on ClinicalTrials.gov →