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Expected pharmacological effect
Causality assessment · Expected pharmacological effect
Brexpiprazole 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.
Brexpiprazole ↔ Weight Increased
n=1,702 co-reports · PRR 9.8 · ROR 10.8
Buprenorphine is a partial mu-opioid agonist for opioid dependence and pain. Drug abuse is the expected consequence of mu-opioid activity, although its ceiling effect reduces respiratory depression risk. 4,074 co-reports (PRR 10.6) reflect both medical use and diversion. The label carries a boxed warning for abuse, dependence, and misuse.
Boxed warning: buprenorphine label (abuse/dependence/misuse). DEA Schedule III.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 10.6 with 4,074 co-reports |
| Consistency | met | Reproduced across opioid class |
| Specificity | partial | Specific to mu-opioid agonists |
| Biological gradient | met | Tolerance documented |
| Plausibility | met | Known mu-opioid mechanism |
| Coherence | met | Withdrawal recognised |
| Experiment | n/a | Not an RCT endpoint |
| Analogy | met | Other opioids show dependence |
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 Brexpiprazole captured weight increased as a tracked adverse event in a usable structure. Buprenorphine RCTs measure treatment retention; abuse liability assessed in separate studies.