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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Ziprasidone 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.
Ziprasidone ↔ Weight Increased
n=1,180 co-reports · PRR 6.4 · ROR 6.8
Pregabalin is a gabapentinoid for neuropathic pain. Drug abuse is the expected consequence: euphoria, tolerance, withdrawal, and gabapentinoid misuse are well-documented (Schedule V). 2,400 co-reports (PRR 14.0) reflect its abuse liability. The label carries a boxed warning for abuse, dependence, and withdrawal.
Boxed warning: pregabalin label (abuse/dependence/withdrawal). DEA Schedule V.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 14.0 with 2,400 co-reports |
| Consistency | met | Reproduced across gabapentinoid class |
| Specificity | partial | Specific to calcium channel ligands |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | Known mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Gabapentin shows same pattern |
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 Ziprasidone captured weight increased as a tracked adverse event in a usable structure. Pain RCTs are short-term; abuse liability assessed in separate studies.