VARENICLINE

N/A

Manufactured by Oyster Point Pharma, Inc.

10,186 FDA adverse event reports analyzed

Last updated: 2026-04-15

About VARENICLINE

VARENICLINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Oyster Point Pharma, Inc.. The most commonly reported adverse reactions for VARENICLINE include SNEEZING, NAUSEA, DRUG INEFFECTIVE, VOMITING, DEPRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VARENICLINE.

Top Adverse Reactions

SNEEZING732 reports
NAUSEA558 reports
DRUG INEFFECTIVE457 reports
VOMITING381 reports
DEPRESSION349 reports
HEADACHE289 reports
NASAL DISCOMFORT260 reports
PRODUCT DELIVERY MECHANISM ISSUE252 reports
RHINORRHOEA226 reports
NIGHTMARE212 reports
ABNORMAL DREAMS210 reports
SUICIDAL IDEATION207 reports
COUGH196 reports
INSOMNIA188 reports
EYE PAIN181 reports
THROAT IRRITATION178 reports
DIZZINESS170 reports
EPISTAXIS169 reports
ANXIETY158 reports
AGITATION153 reports
DYSPNOEA140 reports
EYE IRRITATION130 reports
OFF LABEL USE129 reports
PRODUCT DOSE OMISSION ISSUE126 reports
FATIGUE119 reports
RASH117 reports
DIARRHOEA109 reports
PAIN95 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS95 reports
DRUG INTERACTION93 reports
VISION BLURRED93 reports
CONDITION AGGRAVATED88 reports
LACRIMATION INCREASED88 reports
FEELING ABNORMAL87 reports
PRURITUS86 reports
IRRITABILITY83 reports
OROPHARYNGEAL PAIN83 reports
HYPERSENSITIVITY76 reports
OCULAR HYPERAEMIA76 reports
ABDOMINAL DISCOMFORT70 reports
CONSTIPATION70 reports
PRODUCT USE ISSUE69 reports
CONFUSIONAL STATE67 reports
DRY EYE66 reports
ASTHENIA62 reports
MOOD SWINGS60 reports
HALLUCINATION58 reports
MALAISE58 reports
INTENTIONAL PRODUCT MISUSE57 reports
DEVICE DELIVERY SYSTEM ISSUE56 reports
SOMNOLENCE55 reports
PALPITATIONS54 reports
RHINALGIA53 reports
ANGER52 reports
THERAPY INTERRUPTED52 reports
AGGRESSION51 reports
ARTHRALGIA51 reports
NASAL CONGESTION50 reports
ABDOMINAL PAIN UPPER49 reports
ACCIDENTAL EXPOSURE TO PRODUCT49 reports
THERAPY CESSATION49 reports
MUSCLE SPASMS48 reports
BURNING SENSATION45 reports
CHEST PAIN44 reports
PNEUMONIA44 reports
TREMOR44 reports
SINUSITIS43 reports
PAIN IN EXTREMITY42 reports
THERAPEUTIC RESPONSE UNEXPECTED42 reports
URTICARIA42 reports
DRUG HYPERSENSITIVITY41 reports
DRY MOUTH41 reports
PHOTOPHOBIA41 reports
DYSGEUSIA40 reports
SUICIDE ATTEMPT40 reports
WEIGHT DECREASED40 reports
EYE SWELLING39 reports
PARAESTHESIA39 reports
PRODUCT USE COMPLAINT39 reports
UPPER AIRWAY COUGH SYNDROME39 reports
ILLNESS37 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION37 reports
NASOPHARYNGITIS37 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE37 reports
VISUAL IMPAIRMENT37 reports
FALL36 reports
HEPATOTOXICITY36 reports
MOOD ALTERED36 reports
ABDOMINAL PAIN35 reports
HEPATIC CIRRHOSIS35 reports
TREATMENT NONCOMPLIANCE35 reports
ERYTHEMA34 reports
PYREXIA34 reports
SLEEP DISORDER34 reports
BACK PAIN33 reports
DRUG INDUCED LIVER INJURY33 reports
GASTROOESOPHAGEAL REFLUX DISEASE33 reports
TOXICITY TO VARIOUS AGENTS33 reports
DEVICE DIFFICULT TO USE32 reports
HYPERTENSION32 reports

Report Outcomes

Out of 5,760 classified reports for VARENICLINE:

Serious 23.9%Non-Serious 76.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female3,007 (57.9%)
Male2,180 (42.0%)
Unknown7 (0.1%)

Reports by Age

Age 60132 reports
Age 53126 reports
Age 61123 reports
Age 62118 reports
Age 59113 reports
Age 63110 reports
Age 5899 reports
Age 6499 reports
Age 5691 reports
Age 5184 reports
Age 6578 reports
Age 5775 reports
Age 5274 reports
Age 5572 reports
Age 6672 reports
Age 7070 reports
Age 7168 reports
Age 5467 reports
Age 6766 reports
Age 4863 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with VARENICLINE?

This profile reflects 10,186 FDA FAERS reports that mention VARENICLINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for VARENICLINE?

Frequently reported terms in FAERS include SNEEZING, NAUSEA, DRUG INEFFECTIVE, VOMITING, DEPRESSION, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures VARENICLINE?

Labeling and FAERS entries often list Oyster Point Pharma, Inc. in connection with VARENICLINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.