Zuranolone side effects: what 1,549 FDA adverse event reports show
Drug class
Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Brand names
Zurzuvae
Who reports
1,549 reports · 14% serious · 7 with death outcome · 99% female
Used for
ZURZUVAE is indicated for the treatment of postpartum depression (PPD) in adults. ZURZUVAE is a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator indicated for the treatment of postpartum depression (PPD) in adults. ( 1 )
What it is
ZURZUVAE contains zuranolone, a neuroactive steroid gamma-aminobutyric acid (GABA) A receptor positive modulator.
Boxed warning
IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . A.
Causality screen of the 30 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Sedation | 118 | 60.4 50.7–71.9ROR 65.2 · χ² 6,808 / p <1e-300 | 59.6 EB05 51.1 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 | no trial data cached |
| Brain fog | 53 | 48.4 37.1–63.1ROR 50.1 · χ² 2,407 / p <1e-300 | 47.5 EB05 37.7 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · 72% consumer | no trial data cached |
| Somnolence (drowsiness) | 519 | 34.4 32.0–36.9ROR 50.7 · χ² 16,900 / p <1e-300 | 34.2 EB05 31.8 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.8 | no trial data cached |
| Motor dysfunction | 19 | 25.0 16.0–39.1ROR 25.3 · χ² 413 / p 4e-92 | 24.4 EB05 16.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Muscle twitching | 34 | 19.6 14.0–27.3ROR 20.0 · χ² 580 / p 2e-128 | 19.3 EB05 14.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.4 | no trial data cached |
| Therapy change | 13 | 17.9 10.4–30.8ROR 18.1 · χ² 191 / p 1e-43 | 17.1 EB05 9.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Euphoric mood | 11 | 14.2 7.9–25.6ROR 14.3 · χ² 122 / p 1e-28 | 12.6 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 95 | 13.8 11.3–16.7ROR 14.6 · χ² 1,117 / p 4e-245 | 13.7 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 54.1 | no trial data cached |
| Mania | 16 | 12.9 7.9–21.1ROR 13.1 · χ² 165 / p 6e-38 | 11.9 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.6 | no trial data cached |
| Crying | 33 | 12.0 8.6–16.9ROR 12.3 · χ² 323 / p 2e-72 | 11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Therapy cessation | 45 | 11.7 8.8–15.6ROR 12.0 · χ² 431 / p 6e-96 | 11.4 EB05 8.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 98% clinician | no trial data cached |
| Gait inability | 28 | 11.2 7.8–16.2ROR 11.4 · χ² 251 / p 7e-57 | 10.6 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Panic attack | 30 | 10.9 7.7–15.6ROR 11.1 · χ² 261 / p 5e-59 | 10.3 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 | no trial data cached |
| Dysarthria (slurred speech) | 29 | 10.2 7.1–14.7ROR 10.4 · χ² 233 / p 7e-53 | 9.6 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 75% consumer | no trial data cached |
| Hypersomnia | 22 | 10.2 6.7–15.5ROR 10.3 · χ² 174 / p 5e-40 | 9.3 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Emotional disorder | 22 | 9.4 6.2–14.3ROR 9.5 · χ² 157 / p 2e-36 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Loss of personal independence in daily activities | 32 | 8.9 6.3–12.6ROR 9.1 · χ² 218 / p 1e-49 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 97% clinician | no trial data cached |
| Anger | 21 | 8.2 5.4–12.6ROR 8.3 · χ² 126 / p 1e-29 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 70% consumer | no trial data cached |
| Dizziness | 304 | 8.1 7.3–9.0ROR 9.8 · χ² 1,934 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Tremor (shaking) | 93 | 7.4 6.1–9.1ROR 7.8 · χ² 515 / p 2e-114 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Depressed mood | 25 | 6.3 4.3–9.3ROR 6.4 · χ² 107 / p 3e-25 | 5.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.3 | no trial data cached |
| Memory impairment | 63 | 6.1 4.8–7.8ROR 6.3 · χ² 264 / p 1e-59 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Disorientation | 18 | 6.0 3.8–9.5ROR 6.1 · χ² 71 / p 2e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Balance disorder | 39 | 6.0 4.4–8.2ROR 6.1 · χ² 158 / p 2e-36 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Feeling abnormal | 108 | 6.0 5.0–7.2ROR 6.3 · χ² 446 / p 2e-99 | 5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Irritability | 27 | 6.0 4.1–8.7ROR 6.0 · χ² 107 / p 3e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Mental impairment | 10 | 5.5 3.0–10.2ROR 5.5 · χ² 32 / p 7e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Psychotic disorder | 11 | 4.9 2.7–8.9ROR 5.0 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 | no trial data cached |
| Nightmare | 12 | 4.6 2.6–8.1ROR 4.6 · χ² 30 / p 2e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Mood swings | 11 | 4.6 2.5–8.3ROR 4.6 · χ² 27 / p 9e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Somnolence (drowsiness) | 519 | 34.4 32.0–36.9ROR 50.7 · χ² 16,900 / p <1e-300 | 34.2 EB05 31.8 · IC025 +4.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.8 | no trial data cached |
| Dizziness | 304 | 8.1 7.3–9.0ROR 9.8 · χ² 1,934 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Sedation | 118 | 60.4 50.7–71.9ROR 65.2 · χ² 6,808 / p <1e-300 | 59.6 EB05 51.1 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 | no trial data cached |
| Feeling abnormal | 108 | 6.0 5.0–7.2ROR 6.3 · χ² 446 / p 2e-99 | 5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 95 | 13.8 11.3–16.7ROR 14.6 · χ² 1,117 / p 4e-245 | 13.7 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 54.1 | no trial data cached |
| Tremor (shaking) | 93 | 7.4 6.1–9.1ROR 7.8 · χ² 515 / p 2e-114 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Memory impairment | 63 | 6.1 4.8–7.8ROR 6.3 · χ² 264 / p 1e-59 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Brain fog | 53 | 48.4 37.1–63.1ROR 50.1 · χ² 2,407 / p <1e-300 | 47.5 EB05 37.7 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 · 72% consumer | no trial data cached |
| Therapy cessation | 45 | 11.7 8.8–15.6ROR 12.0 · χ² 431 / p 6e-96 | 11.4 EB05 8.7 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 · 98% clinician | no trial data cached |
| Balance disorder | 39 | 6.0 4.4–8.2ROR 6.1 · χ² 158 / p 2e-36 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Muscle twitching | 34 | 19.6 14.0–27.3ROR 20.0 · χ² 580 / p 2e-128 | 19.3 EB05 14.4 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.4 | no trial data cached |
| Crying | 33 | 12.0 8.6–16.9ROR 12.3 · χ² 323 / p 2e-72 | 11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Loss of personal independence in daily activities | 32 | 8.9 6.3–12.6ROR 9.1 · χ² 218 / p 1e-49 | 8.3 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 97% clinician | no trial data cached |
| Panic attack | 30 | 10.9 7.7–15.6ROR 11.1 · χ² 261 / p 5e-59 | 10.3 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.1 | no trial data cached |
| Dysarthria (slurred speech) | 29 | 10.2 7.1–14.7ROR 10.4 · χ² 233 / p 7e-53 | 9.6 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 75% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Crying — n=33, PRR 12.0
- Gait inability — n=28, PRR 11.2
- Panic attack — n=30, PRR 10.9
- Dysarthria — n=29, PRR 10.2
- Emotional disorder — n=22, PRR 9.4
- Loss of personal independence in daily activities — n=32, PRR 8.9
- Anger — n=21, PRR 8.2
- Balance disorder — n=39, PRR 6.0
- Feeling abnormal — n=108, PRR 6.0
- Irritability — n=27, PRR 6.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Zuranolone?
In FDA FAERS, the most frequently co-reported reaction terms for Zuranolone are somnolence, dizziness, sedation, feeling abnormal, suicidal ideation, tremor. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Zuranolone have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: IMPAIRED ABILITY TO DRIVE OR ENGAGE IN OTHER POTENTIALLY HAZARDOUS ACTIVITIES ZURZUVAE causes driving impairment due to central nervous system (CNS) depressant effects [see Warnings and Precautions ( 5.1 , 5.2 )] . A.
Do FAERS signals prove that Zuranolone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f18e53b0-d0bb-422d-8de7-ab64b7292b29, effective 20260615; matched on
openfda.generic_name.exact:"ZURANOLONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 40 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.