LUMACAFTOR AND IVACAFTOR

N/A

Manufactured by Vertex Pharmaceuticals Incorporated

12,020 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LUMACAFTOR AND IVACAFTOR

LUMACAFTOR 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 LUMACAFTOR AND IVACAFTOR include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, HOSPITALISATION, DYSPNOEA, PULMONARY FUNCTION TEST DECREASED, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LUMACAFTOR AND IVACAFTOR.

Top Adverse Reactions

INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS1,460 reports
HOSPITALISATION885 reports
DYSPNOEA555 reports
PULMONARY FUNCTION TEST DECREASED396 reports
COUGH391 reports
INFECTION369 reports
CHEST DISCOMFORT343 reports
CYSTIC FIBROSIS325 reports
PNEUMONIA268 reports
MALAISE224 reports
NASOPHARYNGITIS202 reports
FATIGUE199 reports
DIARRHOEA193 reports
RESPIRATION ABNORMAL190 reports
INFLUENZA184 reports
PYREXIA184 reports
NAUSEA183 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION162 reports
VOMITING153 reports
WEIGHT DECREASED147 reports
HEADACHE145 reports
ABDOMINAL PAIN UPPER136 reports
SINUSITIS132 reports
DRUG INEFFECTIVE124 reports
FORCED EXPIRATORY VOLUME DECREASED120 reports
HAEMOPTYSIS117 reports
LIVER FUNCTION TEST INCREASED114 reports
LUNG INFECTION110 reports
DECREASED APPETITE107 reports
DRUG DOSE OMISSION100 reports
PSEUDOMONAS INFECTION99 reports
DRUG INTERACTION98 reports
RASH95 reports
ALANINE AMINOTRANSFERASE INCREASED93 reports
ASPARTATE AMINOTRANSFERASE INCREASED93 reports
CHEST PAIN90 reports
DEATH88 reports
ABDOMINAL PAIN87 reports
CONSTIPATION86 reports
DEPRESSION85 reports
GASTROINTESTINAL DISORDER84 reports
PRODUCTIVE COUGH83 reports
RESPIRATORY SYMPTOM82 reports
TREATMENT NONCOMPLIANCE80 reports
INFLUENZA LIKE ILLNESS77 reports
HEPATIC ENZYME INCREASED76 reports
LUNG DISORDER74 reports
ANXIETY72 reports
VIRAL INFECTION70 reports
CONDITION AGGRAVATED69 reports
GENERAL PHYSICAL HEALTH DETERIORATION69 reports
ABDOMINAL DISCOMFORT68 reports
STAPHYLOCOCCAL INFECTION68 reports
OFF LABEL USE65 reports
INTESTINAL OBSTRUCTION64 reports
LUNG TRANSPLANT63 reports
RESPIRATORY FAILURE62 reports
FLATULENCE57 reports
ALOPECIA53 reports
PNEUMOTHORAX53 reports
WEIGHT INCREASED51 reports
ASTHMA50 reports
SPUTUM INCREASED49 reports
ASTHENIA48 reports
EAR INFECTION48 reports
PAIN48 reports
URTICARIA47 reports
DIZZINESS46 reports
WHEEZING44 reports
DYSPEPSIA42 reports
INSOMNIA42 reports
UPPER RESPIRATORY TRACT INFECTION42 reports
DRUG HYPERSENSITIVITY41 reports
FEELING ABNORMAL41 reports
HYPERSENSITIVITY41 reports
OXYGEN SATURATION DECREASED39 reports
BLOOD GLUCOSE INCREASED37 reports
PRODUCT DOSE OMISSION37 reports
SINUS DISORDER37 reports
BRONCHOSPASM36 reports
RHINORRHOEA35 reports
SUICIDAL IDEATION35 reports
NASAL CONGESTION34 reports
SURGERY34 reports
AGGRESSION33 reports
DEPRESSED MOOD33 reports
OROPHARYNGEAL PAIN33 reports
SINUS OPERATION33 reports
HYPERTENSION32 reports
RESPIRATORY DISORDER32 reports
RESPIRATORY TRACT INFECTION32 reports
THERAPY CESSATION32 reports
BLOOD PRESSURE INCREASED30 reports
INCREASED BRONCHIAL SECRETION30 reports
MIGRAINE30 reports
ABDOMINAL DISTENSION29 reports
ABNORMAL BEHAVIOUR29 reports
LIVER DISORDER29 reports
LOWER RESPIRATORY TRACT INFECTION29 reports
PHARYNGITIS STREPTOCOCCAL29 reports

Report Outcomes

Out of 8,484 classified reports for LUMACAFTOR AND IVACAFTOR:

Serious 63.1%Non-Serious 36.9%

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

Female4,040 (51.7%)
Male3,777 (48.3%)

Reports by Age

Age 16226 reports
Age 15218 reports
Age 18218 reports
Age 13186 reports
Age 17186 reports
Age 11179 reports
Age 12179 reports
Age 19170 reports
Age 14169 reports
Age 6164 reports
Age 10153 reports
Age 20146 reports
Age 9138 reports
Age 23130 reports
Age 7127 reports
Age 22126 reports
Age 21124 reports
Age 28122 reports
Age 2120 reports
Age 3120 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 LUMACAFTOR AND IVACAFTOR?

This profile reflects 12,020 FDA FAERS reports that mention LUMACAFTOR AND IVACAFTOR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LUMACAFTOR AND IVACAFTOR?

Frequently reported terms in FAERS include INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, HOSPITALISATION, DYSPNOEA, PULMONARY FUNCTION TEST DECREASED, COUGH, INFECTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LUMACAFTOR AND IVACAFTOR?

Labeling and FAERS entries often list Vertex Pharmaceuticals Incorporated in connection with LUMACAFTOR 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.