What the label lists and what reports show
Zuranolone side effects
Zuranolone's FDA label: “Most common adverse reactions (incidence ≥5% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.” FAERS holds 1,579 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is somnolence (519 reports).
- No generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the zuranolone FDA label on DailyMed (effective June 15, 2026, Biogen MA Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ZURZUVAE?ZURZUVAE can cause serious side effects, including: See “ What is the most important information I should know about ZURZUVAE? ” Increased risk of suicidal thoughts and actions. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to, and tell your healthcare provider right away about, any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. Keep all follow-up visits with your healthcare provider as scheduled. […]
Source: FDA drug label, Biogen MA Inc., effective June 15, 2026 (SPL set f18e53b0-d0bb-422d-8de7-ab64b7292b29), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection.
Table 2. Adverse Reactions that Occurred in ≥2% of Patients with PPD Treated with 50 mg of ZURZUVAE and Greater than in Patients Treated with Placebo (Study 1)
| Adverse Reaction | Placebo (N=98) (%) | 50 mg of ZURZUVAE (N=98) (%) |
|---|---|---|
| Somnolence 1 | 6 | 36 |
| Dizziness 2 | 9 | 13 |
| Diarrhea | 2 | 6 |
| Fatigue 3 | 2 | 5 |
| Urinary tract infection | 4 | 5 |
| Memory impairment | 0 | 3 |
| Abdominal pain 4 | 0 | 3 |
| Tremor | 0 | 2 |
| Hypoesthesia | 0 | 2 |
| Muscle twitching | 0 | 2 |
| Myalgia | 0 | 2 |
| COVID-19 | 0 | 2 |
| Anxiety | 1 | 2 |
| Rash | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities [see Warnings and Precautions ( 5.1 )] Central Nervous System Depressant Effects [see Warnings and Precautions ( 5.2 )] Suicidal Thoughts and Behavior [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence ≥5% and greater than placebo) were somnolence, dizziness, diarrhea, fatigue, nasopharyngitis, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Biogen at 1-844-987-9882 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ZURZUVAE for the treatment of postpartum depression (PPD) was evaluated in two placebo-controlled clinical studies in 347 women with PPD treated with 50 mg of ZURZUVAE (Study 1), or with another zuranolone capsule formulation approximately equivalent to 40 mg of ZURZUVAE (Study 2) once daily for 14 days [see Clinical Studies ( 14.1 )]. The studies included adult patients 18 to 44 years of age diagnosed with PPD. …
Source: FDA drug label, Biogen MA Inc., effective June 15, 2026 (SPL set f18e53b0-d0bb-422d-8de7-ab64b7292b29), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,579 reports list zuranolone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 70 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Zuranolone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions