IVACAFTOR

N/A

Manufactured by Vertex Pharmaceuticals Incorporated

9,200 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IVACAFTOR

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 IVACAFTOR include HOSPITALISATION, INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, PNEUMONIA, INFECTION, MALAISE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IVACAFTOR.

Top Adverse Reactions

HOSPITALISATION1,286 reports
INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS601 reports
PNEUMONIA262 reports
INFECTION249 reports
MALAISE247 reports
LOWER RESPIRATORY TRACT INFECTION242 reports
DEATH224 reports
COUGH219 reports
CYSTIC FIBROSIS211 reports
HEADACHE194 reports
NASOPHARYNGITIS168 reports
INFLUENZA160 reports
DYSPNOEA141 reports
PULMONARY FUNCTION TEST DECREASED136 reports
OFF LABEL USE120 reports
ABDOMINAL PAIN UPPER113 reports
HAEMOPTYSIS112 reports
VOMITING112 reports
DRUG DOSE OMISSION108 reports
EXPOSURE DURING PREGNANCY108 reports
SINUSITIS105 reports
DIARRHOEA103 reports
WEIGHT DECREASED101 reports
FATIGUE99 reports
WEIGHT INCREASED96 reports
ABDOMINAL PAIN94 reports
DRUG INTERACTION92 reports
NAUSEA92 reports
ANXIETY89 reports
DEPRESSION78 reports
CONSTIPATION75 reports
PYREXIA75 reports
ALANINE AMINOTRANSFERASE INCREASED73 reports
CYSTIC FIBROSIS RESPIRATORY INFECTION SUPPRESSION73 reports
PANCREATITIS71 reports
CHEST DISCOMFORT69 reports
DIZZINESS69 reports
TREATMENT NONCOMPLIANCE69 reports
RASH66 reports
DRUG INEFFECTIVE65 reports
PSEUDOMONAS INFECTION64 reports
ABDOMINAL DISCOMFORT63 reports
PRODUCTIVE COUGH63 reports
SURGERY57 reports
COVID 1956 reports
ABORTION SPONTANEOUS55 reports
MATERNAL EXPOSURE DURING PREGNANCY55 reports
SUICIDAL IDEATION55 reports
DECREASED APPETITE54 reports
OROPHARYNGEAL PAIN54 reports
DEPRESSED MOOD53 reports
INSOMNIA53 reports
CHEST PAIN51 reports
CONDITION AGGRAVATED51 reports
GASTROINTESTINAL DISORDER51 reports
LUNG INFECTION51 reports
ASPARTATE AMINOTRANSFERASE INCREASED49 reports
HEPATIC ENZYME INCREASED49 reports
ILLNESS49 reports
PRODUCT DOSE OMISSION ISSUE49 reports
LUNG DISORDER48 reports
PAIN47 reports
BLOOD ALKALINE PHOSPHATASE INCREASED46 reports
VIRAL INFECTION45 reports
STAPHYLOCOCCAL INFECTION44 reports
FEELING ABNORMAL43 reports
FORCED EXPIRATORY VOLUME DECREASED43 reports
EAR INFECTION42 reports
INTESTINAL OBSTRUCTION42 reports
MENTAL DISORDER42 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED41 reports
ARTHRALGIA40 reports
UPPER RESPIRATORY TRACT INFECTION39 reports
LUNG TRANSPLANT38 reports
PRODUCT DOSE OMISSION38 reports
SLEEP DISORDER38 reports
NASAL CONGESTION37 reports
PULMONARY HAEMORRHAGE37 reports
ASTHENIA35 reports
ASTHMA35 reports
NEUTROPENIA35 reports
NEPHROLITHIASIS34 reports
BLOOD BILIRUBIN INCREASED33 reports
FALL33 reports
HEPATIC CYTOLYSIS33 reports
ILL DEFINED DISORDER33 reports
LIVER FUNCTION TEST INCREASED33 reports
ACUTE KIDNEY INJURY32 reports
RESPIRATORY DISORDER32 reports
RESPIRATORY FAILURE32 reports
FUNGAL INFECTION31 reports
MYALGIA31 reports
PNEUMOTHORAX31 reports
DRUG HYPERSENSITIVITY30 reports
DRUG INDUCED LIVER INJURY30 reports
RHINORRHOEA30 reports
SINUS DISORDER30 reports
SPUTUM INCREASED30 reports
FOETAL EXPOSURE DURING PREGNANCY29 reports
GENERAL PHYSICAL HEALTH DETERIORATION29 reports

Report Outcomes

Out of 7,649 classified reports for IVACAFTOR:

Serious 73.7%Non-Serious 26.3%

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

Female4,101 (56.8%)
Male3,101 (43.0%)
Unknown18 (0.2%)

Reports by Age

Age 18104 reports
Age 6102 reports
Age 11101 reports
Age 1686 reports
Age 2686 reports
Age 883 reports
Age 1480 reports
Age 1979 reports
Age 777 reports
Age 1274 reports
Age 3373 reports
Age 2072 reports
Age 1569 reports
Age 2269 reports
Age 2469 reports
Age 1068 reports
Age 266 reports
Age 566 reports
Age 2565 reports
Age 2765 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 IVACAFTOR?

This profile reflects 9,200 FDA FAERS reports that mention IVACAFTOR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IVACAFTOR?

Frequently reported terms in FAERS include HOSPITALISATION, INFECTIVE PULMONARY EXACERBATION OF CYSTIC FIBROSIS, PNEUMONIA, INFECTION, MALAISE, LOWER RESPIRATORY TRACT INFECTION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures IVACAFTOR?

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