ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

N/A

Manufactured by Vertex Pharmaceuticals Incorporated

19,269 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR

ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Vertex Pharmaceuticals Incorporated. The most commonly reported adverse reactions for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, HEADACHE, COUGH, ANXIETY, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR.

Top Adverse Reactions

INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS777 reports
HEADACHE747 reports
COUGH579 reports
ANXIETY575 reports
RASH560 reports
PRODUCTIVE COUGH519 reports
FATIGUE513 reports
WEIGHT INCREASED494 reports
CYSTIC FIBROSIS475 reports
ABDOMINAL PAIN UPPER460 reports
DEPRESSION418 reports
HOSPITALISATION403 reports
DIARRHOEA375 reports
PNEUMONIA372 reports
INFECTION328 reports
NAUSEA316 reports
MENTAL DISORDER314 reports
INSOMNIA312 reports
DYSPNOEA297 reports
INFLUENZA284 reports
CONSTIPATION268 reports
NASOPHARYNGITIS246 reports
PRODUCT DOSE OMISSION ISSUE240 reports
DIZZINESS230 reports
ABDOMINAL PAIN229 reports
COVID 19227 reports
FEELING ABNORMAL226 reports
HEPATIC ENZYME INCREASED210 reports
OFF LABEL USE209 reports
VOMITING196 reports
GASTROINTESTINAL DISORDER195 reports
PULMONARY FUNCTION TEST DECREASED194 reports
BRAIN FOG191 reports
ILLNESS191 reports
LIVER FUNCTION TEST INCREASED175 reports
EXPOSURE DURING PREGNANCY174 reports
HAEMOPTYSIS173 reports
PYREXIA171 reports
MALAISE169 reports
ALANINE AMINOTRANSFERASE INCREASED166 reports
WEIGHT DECREASED165 reports
ABDOMINAL DISTENSION160 reports
ABDOMINAL DISCOMFORT159 reports
ASPARTATE AMINOTRANSFERASE INCREASED155 reports
ACNE152 reports
CHEST DISCOMFORT149 reports
SUICIDAL IDEATION147 reports
PRURITUS142 reports
SLEEP DISORDER142 reports
PAIN140 reports
RHINORRHOEA137 reports
CHEST PAIN129 reports
ARTHRALGIA128 reports
RASH PRURITIC127 reports
DEATH125 reports
DECREASED APPETITE125 reports
BLOOD BILIRUBIN INCREASED123 reports
ASTHENIA117 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION114 reports
LUNG DISORDER109 reports
ANGER105 reports
SINUSITIS105 reports
AGGRESSION104 reports
DEPRESSED MOOD102 reports
NEPHROLITHIASIS102 reports
IRRITABILITY101 reports
MEMORY IMPAIRMENT101 reports
SINUS DISORDER100 reports
MIGRAINE96 reports
FLATULENCE95 reports
BACK PAIN93 reports
VIRAL INFECTION93 reports
PSEUDOMONAS INFECTION92 reports
SPUTUM INCREASED92 reports
OROPHARYNGEAL PAIN90 reports
ALOPECIA87 reports
INTESTINAL OBSTRUCTION87 reports
NASAL CONGESTION86 reports
PERIPHERAL SWELLING83 reports
URTICARIA83 reports
INCREASED APPETITE81 reports
BEHAVIOUR DISORDER80 reports
SOMNOLENCE79 reports
MOOD SWINGS75 reports
PARANASAL SINUS HYPERSECRETION75 reports
DEHYDRATION74 reports
LIVER DISORDER74 reports
STRESS74 reports
WHEEZING74 reports
RESPIRATORY TRACT CONGESTION73 reports
DRUG INEFFECTIVE72 reports
DYSPEPSIA72 reports
DRUG INTERACTION67 reports
DRY EYE67 reports
SEIZURE67 reports
EMOTIONAL DISORDER66 reports
HORDEOLUM66 reports
PANIC ATTACK65 reports
BLOOD ALKALINE PHOSPHATASE INCREASED64 reports
MOOD ALTERED64 reports

Report Outcomes

Out of 11,817 classified reports for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR:

Serious 41.6%Non-Serious 58.4%

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

Female5,897 (58.2%)
Male4,235 (41.8%)

Reports by Age

Age 12233 reports
Age 18203 reports
Age 19196 reports
Age 16190 reports
Age 20188 reports
Age 25177 reports
Age 17176 reports
Age 24176 reports
Age 23166 reports
Age 32165 reports
Age 15161 reports
Age 13156 reports
Age 30154 reports
Age 31153 reports
Age 22149 reports
Age 21147 reports
Age 14145 reports
Age 29143 reports
Age 26131 reports
Age 27128 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 ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR?

This profile reflects 19,269 FDA FAERS reports that mention ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR?

Frequently reported terms in FAERS include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, HEADACHE, COUGH, ANXIETY, RASH, PRODUCTIVE COUGH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR?

Labeling and FAERS entries often list Vertex Pharmaceuticals Incorporated in connection with ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR. 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.