Zuranolone Side Effects

Applies to zuranolone: oral capsule.

Important warnings This medicine can cause some serious health issues

Oral route (capsule)

Warning: Impaired Ability to Drive or Engage in Other Potentially Hazardous Activities. Zuranolone 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 side effects

• 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 side effects

• 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 side effects

• lack or loss of strength

Less common side effects

• 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 adverse events

The most common adverse reactions in patients treated with this drug were somnolence, dizziness, diarrhea, fatigue, and urinary tract infections.^[Ref]

Dermatologic

• Common (1% to 10%): Rash^[Ref]

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]

Further information

Zuranolone side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer