Tyrvaya Side Effects
Generic name: varenicline
Note: This document contains side effect information about varenicline. Some dosage forms listed on this page may not apply to the brand name Tyrvaya.
Applies to varenicline: nasal spray.
Serious side effects of Tyrvaya
Along with its needed effects, varenicline (the active ingredient contained in Tyrvaya) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Other side effects of Tyrvaya
Some side effects of varenicline 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, redness, or swelling around or inside the nose
- sore throat
For Healthcare Professionals
Applies to varenicline: nasal spray, oral tablet.
Very common (10% or more): Insomnia (up to 19%), abnormal dreams (up to 13%), depressed mood disorders and disturbances (up to 11%), irritability (up to 11%)
Uncommon (0.1% to 1%): Aggression, dissociation, hallucinations, libido decreased, libido increased, mood swings, panic reaction, suicidal ideation, thinking abnormal
Rare (less than 0.1%): Abnormal behavior, bradyphrenia, disorientation, dysphoria, euphoric mood, psychosis, somnambulism
Frequency not reported: Early morning awakening, initial insomnia, neuropsychiatric adverse events, suicidality
Postmarketing reports: Aggressive behavior, changes in behavior, changes in thinking, delusions, completed suicide, exacerbation of underlying psychiatric illness, homicidal ideation, nicotine withdrawal symptoms, panic, suicide, suicide attempt[Ref]
Very common (10% or more): Nausea (up to 40%), vomiting (up to 11%)
Common (1% to 10%): Abdominal discomfort, abdominal distension, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, gastroesophageal reflux disease, toothache
Very common (10% or more): Headache (up to 19%)
Rare (less than 0.1%): Balance disorder, cerebrovascular accident, coordination abnormal, circadian rhythm sleep disorder, dysarthria, hypertonia, mental impairment, multiple sclerosis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, scotoma, sensory disturbance, transient ischemic attack, VIIth nerve paralysis, visual field defect
Frequency not reported: Transient loss of consciousness
Postmarketing reports: Blackouts, hemorrhagic cerebrovascular event, ischemic cerebrovascular event, loss of consciousness[Ref]
Very common (10% or more): Nasopharyngitis (up to 11%)
Uncommon (0.1% to 1%): Allergic rhinitis, asthma, dysphonia, epistaxis, respiratory tract congestion, sinus congestion, throat irritation, upper- airway cough syndrome, upper respiratory tract inflammation
Common (1% to 10%): Angina pectoris, chest pain, hospitalization for angina pectoris, hypertension, need for coronary revascularization, new diagnosis of peripheral vascular disease (PVD)/admission for a PVD procedure, nonfatal myocardial infarction, peripheral edema
Uncommon (0.1% to 1%): Blood pressure increased, chest discomfort, ECG abnormal, edema, heart rate increased, hospitalization for angina pectoris, hot flush, myocardial infarction, palpitations, tachycardia
Rare (less than 0.1%): Acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, electrocardiogram ST segment depression, electrocardiogram T wave amplitude decreased, thrombosis, ventricular extrasystoles
Frequency not reported: Cardiovascular events[Ref]
Common (1% to 10%): Anorexia, decreased appetite, increased appetite, weight increased
Common (1% to 10%): Arthralgia, back pain, myalgia, pain in extremity
Uncommon (0.1% to 1%): arthritis, muscle cramp, muscle spasms, musculoskeletal chest pain, musculoskeletal pain
Common (1% to 10%): Asthenia, fatigue, malaise
Uncommon (0.1% to 1%): Chills, pyrexia, tinnitus
Rare (less than 0.1%): Cyst, deafness, feeling cold, Meniere's disease
Frequency not reported: Accidental injury, interaction with alcohol[Ref]
Common (1% to 10%): Pruritus, rash
Frequency not reported: Serious skin reactions[Ref]
Common (1% to 10%): Menstrual disorder
Common (1% to 10%): Influenza
Uncommon (0.1% to 1%): Fungal infection, influenza like illness, viral infection[Ref]
Common (1% to 10%): Liver function test abnormal[Ref]
Rare (less than 0.1%): Blindness transient, cataract subcapsular, dry eye, lacrimation increased, mydriasis, myopia, night blindness, ocular vascular disorder, photophobia, scleral discoloration, vitreous floaters[Ref]
Uncommon (0.1% to 1%): Thyroid gland disorders[Ref]
Rare (less than 0.1%): Angioedema
Frequency not reported: Hypersensitivity reactions[Ref]
More about Tyrvaya (varenicline)
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Related treatment guides
- Product Information. Tyrvaya (varenicline solution), Oyster Point Pharma, Princeton N.J.
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.