Spravato Side Effects
Generic Name: esketamine
Medically reviewed by Drugs.com. Last updated on Oct 23, 2020.
Note: This document contains side effect information about esketamine. Some of the dosage forms listed on this page may not apply to the brand name Spravato.
For the Consumer
Applies to esketamine: nasal spray
Nasal route (Spray)
Warning: Sedation; Dissociation; Abuse and Misuse; and Suicidal Thoughts and BehaviorsRisk for sedation and dissociation after administration. Monitor patients for at least 2 hours after administration.Potential for abuse and misuse. Consider the risks and benefits of prescribing esketamine prior to using in patients at higher risk of abuse. Monitor patients for signs and symptoms of abuse and misuse.Esketamine is only available through a restricted program call the SPRAVATO(TM) REMS.Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Esketamine is not approved for use in pediatric patients.
Side effects requiring immediate medical attention
Along with its needed effects, esketamine (the active ingredient contained in Spravato) 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 esketamine:
- blurred vision
- confusion about identity, time, and place
- feeling of constant movement of self or surroundings
- feeling of unreality
- pounding in the ears
- relaxed and calm feeling
- sensation of spinning
- sense of detachment from self or body
- slow or fast heartbeat
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Changes in patterns and rhythms of speech
- false or unusual sense of well-being
- fast, pounding, or irregular heartbeat or pulse
- feeling abnormal or drunk
- frequent daytime urination
- nightmares or unusually vivid dreams
- slurred speech
- trouble in speaking
- urinating small amounts of urine at a time
- Changes in behavior
- chest pain or discomfort
- fast or pounding heartbeat
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- thoughts of killing oneself
- trouble concentrating
- trouble sleeping
Side effects not requiring immediate medical attention
Some side effects of esketamine 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:
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in or loss of taste
- nasal itching, burning, or irritation
- throat irritation
- dry mouth
- mouth or throat pain
For Healthcare Professionals
Applies to esketamine: nasal spray
The most commonly reported side effects included dissociation, sedation, nausea, and dizziness.[Ref]
Dissociation (e.g., depersonalization, derealization, perceptual changed [distortion of time, place, and illusions]) occurred in up to 75% of patients 65 years and older given this drug PLUS oral antidepressant therapy.[Ref]
Very common (10% or more): Dissociation (up to 75%), anxiety (up to 13%)
Common (1% to 10%): Agitation, altered time perception, anxiety, derealization, euphoric mood, hallucination, illusion, insomnia, irritability, panic attack, visual hallucination
Uncommon (0.1% to 1%): Suicidal ideation
Frequency not reported: Anticipatory anxiety, auditory hallucination, delusional perception, depersonalization/derealization disorder, fear, nervousness, tension
Common (1% to 10%): Nightmares, vivid dreams
Frequency not reported: Anxiety, disorientation, dysphoria, hallucinations[Ref]
Sedation occurred in up to 61% of patients younger than 65 years given 84 mg of this drug intranasally PLUS oral antidepressant therapy.
Clonic and tonic movements resembling convulsions occurred as a result of increased muscle tonus in patients given parenteral formulations.
Increased brain pressure occurred in patients given parenteral formulations who were not under adequate ventilation.[Ref]
Very common (10% or more): Sedation (up to 61%), dizziness (up to 30%), headache (up to 24%), vertigo (up to 23%), dysgeusia (up to 19%), hypoesthesia (up to 18%), somnolence (up to 18%), lethargy (up to 11%)
Common (1% to 10%): Dysarthria, mental impairment, paresthesia, tremor
Frequency not reported: Altered state of consciousness, cognitive impairment, dizziness exertional, dizziness postural, dysesthesia, hypersomnia, hypogeusia, impaired ability to drive/operate machinery, procedural dizziness, sinus headache, slow speech, speech disorder, vertigo positional
Common (1% to 10%): Dizziness, increased brain pressure, motor restlessness
Uncommon (0.1% to 1%): Clonic movements, convulsions, nystagmus, tonic movements[Ref]
Nausea occurred in 32% of patients given 84 mg intranasal doses and 27% of patients given 56 mg intranasal doses. Severe nausea was reported in 3% of patients given 84 mg intranasal doses.
Vomiting occurred in 6% of patients given 84 mg intranasal doses and 12% of patients given 56 mg intranasal doses. Severe nausea was reported in 3% of patients given 84 mg intranasal doses.[Ref]
Very common (10% or more): Nausea (up to 32%), vomiting (up to 12%)
Common (1% to 10%): Constipation, diarrhea, dry mouth, oral hypesthesia, severe nausea, severe vomiting
Uncommon (0.1% to 1%): Salivary hypersecretion
Frequency not reported: Hypoesthesia teeth, oral dysesthesia, paresthesia oral
Common (1% to 10%): Increased salivation, nausea, vomiting[Ref]
At least 25 mmHg increase in diastolic blood pressure occurred in up to 14% of patients 65 years and older given this drug PLUS oral antidepressant therapy.
At least 40 mmHg increase in systolic blood pressure occurred in up to 17% of patients 65 years and older given this drug PLUS oral antidepressant therapy.
Blood pressure and heart rate increases of 20% from baseline occurred in patients given parenteral formulations.
Hypotension in parenteral formulations occurred, especially with circulatory shock. Patients with shock developed further reductions in blood pressure.
Increased vascular resistance in pulmonary circulation occurred with parenteral formulations, especially in those with restricted coronary reserve.[Ref]
Very common (10% or more): At least 40 mmHg increase in systolic blood pressure (up to 17%), at least 25 mmHg increase in diastolic blood pressure (up to 14%)
Common (1% to 10%): Blood pressure increased, diastolic blood pressure at least 110 mmHg, systolic blood pressure at least 180 mmHg, tachycardia
Frequency not reported: Blood pressure diastolic increased, blood pressure systolic increased, extrasystoles, heart rate increased, hypertension
Common (1% to 10%): Blood pressure increase, heart rate increase, increased vascular resistance in pulmonary circulation, temporary tachycardia
Rare (0.01% to 0.1%): Arrythmia, bradycardia, hypotension
Very rare (less than 0.01%): Severe hypotension
Frequency not reported: Circulatory shock[Ref]
Common (1% to 10%): Nasal crusting, nasal discomfort, nasal dryness, nasal pruritus, oropharyngeal pain, pharyngeal paresthesia, throat irritation
Common (1% to 10%): Feeling abnormal, feeling drunk, feeling of body temperature change, hyperacusis, tinnitus
Frequency not reported: Embryofetal toxicity, fatigue, feeling cold, feeling hot, feeling jittery
Common (1% to 10%): Increased mucus secretion, recovery reactions[Ref]
Increased mucus secretion occurred with parenteral formulations, especially in those with restricted coronary reserve.[Ref]
Common (1% to 10%): Dysuria, micturition urgency, pollakiuria
Common (1% to 10%): Blurred vision
Frequency not reported: Diplopia, ocular discomfort, photophobia, visual impairment
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, increased intraocular pressure[Ref]
Common (1% to 10%): Hyperreflexia, laryngeal spasms
Hyperreflexia and laryngospasm may occur in parenteral formulations with upper respiratory tract diagnostic and/or therapeutic interventions, especially in pediatric patients; muscle relaxation with adequate ventilation may be needed in procedures involving the bronchial tree, larynx, and/or pharynx.[Ref]
Common (1% to 10%): Hyperhidrosis
Uncommon (0.1% to 1%): Exanthema, morbilliform rash[Ref]
Increased muscle tone occurred in patients given parenteral formulations who were not under adequate ventilation.[Ref]
Uncommon (0.1% to 1%): Muscular weakness
Common (1% to 10%): Increased muscle tone[Ref]
Rare (0.01% to 0.1%): Anaphylaxis
Very rare (less than 0.01%): Anaphylactoid reactions, hypersensitivity reactions[Ref]
Drug-induced liver injury occurred in extended use (e.g., greater than 3 days) and/or with abuse.[Ref]
Common (1% to 10%): Increased oxygen consumption[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Spravato (esketamine)." Janssen Pharmaceuticals, Titusville, NJ.
Frequently asked questions
More about Spravato (esketamine)
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
- Pricing & Coupons
- En Español
- 44 Reviews
- Drug class: miscellaneous antidepressants
- FDA Approval History
Related treatment guides
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.