Zurzuvae Side Effects

Generic name: zuranolone

Note: This document contains side effect information about zuranolone. Some dosage forms listed on this page may not apply to the brand name Zurzuvae.

Applies to zuranolone: oral capsule.

Serious side effects of Zurzuvae

Along with its needed effects, zuranolone (the active ingredient contained in Zurzuvae) 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 Zurzuvae

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

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]

Frequently asked questions

• How does Zurzuvae differ from traditional antidepressants?

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.

Medical Disclaimer