Zuranolone Side Effects
Applies to zuranolone: oral capsule.
Warning
Oral route (Capsule)
Warning: Impaired Ability to Drive or Engage in Other Potentially Hazardous ActivitiesZuranolone causes driving impairment due to central nervous system (CNS) depressant effects.Advise patients not to drive or engage in other potentially hazardous activities until at least 12 hours after zuranolone administration for the duration of the 14-day treatment course. Inform patients that they may not be able to assess their own driving competence, or the degree of driving impairment caused by zuranolone.
Serious side effects of Zuranolone
Along with its needed effects, zuranolone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking zuranolone:
More common
- Body aches or pain
- bladder pain
- bloody or cloudy urine
- cough
- difficult, burning, or painful urination
- dizziness
- ear congestion
- fever
- frequent urge to urinate
- headache
- loss of voice
- lower back or side pain
- muscle aches
- sleepiness or unusual drowsiness
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Less common
- Being forgetful
- chills
- diarrhea
- fear, nervousness
- loss of taste or smell
- muscle pain
- nausea
- shakiness in the legs, arms, hands, or feet
- trembling or shaking of the hands or feet
- vomiting
Incidence not known
- Changes in behavior
- thoughts or attempts at killing oneself
Other side effects of Zuranolone
Some side effects of zuranolone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Lack or loss of strength
Less common
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- difficulty in moving
- dry mouth
- joint pain
- muscle aches, cramps, or stiffness
- stomach pain
- swollen joints
- toothache
For Healthcare Professionals
Applies to zuranolone: oral capsule.
General
The most common adverse reactions in patients treated with this drug were somnolence, dizziness, diarrhea, fatigue, and urinary tract infections.[Ref]
Dermatologic
Gastrointestinal
Common (1% to 10%): Diarrhea, abdominal pain, dry mouth, toothache[Ref]
Abdominal pain includes upper abdominal pain[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Musculoskeletal
Common (1% to 10%): Muscle twitching, myalgia[Ref]
Nervous system
Very common (10% or more): Somnolence (up to 36%), dizziness (up to 13%)
Common (1% to 10%): Memory impairment, tremor, hypoesthesia
Somnolence includes sedation and hypersomnia
Other
Common (1% to 10%): Fatigue[Ref]
Fatigue includes asthenia and lethargy[Ref]
Psychiatric
Common (1% to 10%): Anxiety, confusional state[Ref]
Respiratory
Common (1% to 10%): COVID-19, nasopharyngitis, sinus congestion[Ref]
Nasopharyngitis includes upper respiratory tract infection[Ref]
More about zuranolone
- Check interactions
- Compare alternatives
- Dosage information
- During pregnancy
- Drug class: miscellaneous antidepressants
- Breastfeeding
- En español
Patient resources
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Professional resources
Other brands
Related treatment guides
References
1. Product Information. Zurzuvae (zuranolone). Biogen Inc. 2023.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.