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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Does IVACAFTOR Cause Malaise? 226 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 226 reports of Malaise have been filed in association with IVACAFTOR (Kalydeco). This represents 3.4% of all adverse event reports for IVACAFTOR.

226
Reports of Malaise with IVACAFTOR
3.4%
of all IVACAFTOR reports
5
Deaths
137
Hospitalizations

How Dangerous Is Malaise From IVACAFTOR?

Of the 226 reports, 5 (2.2%) resulted in death, 137 (60.6%) required hospitalization, and 1 (0.4%) were considered life-threatening.

Is Malaise Listed in the Official Label?

This adverse event is not currently listed in the official FDA drug label for IVACAFTOR. However, 226 reports have been filed with the FAERS database.

What Other Side Effects Does IVACAFTOR Cause?

Hospitalisation (1,209) Infective pulmonary exacerbation of cystic fibrosis (550) Infection (227) Lower respiratory tract infection (224) Pneumonia (215) Death (203) Cough (180) Cystic fibrosis (167) Headache (163) Nasopharyngitis (151)

What Other Drugs Cause Malaise?

ADALIMUMAB (15,965) ETANERCEPT (13,600) METHOTREXATE (9,970) TOFACITINIB (9,040) SECUKINUMAB (8,570) INFLIXIMAB (7,477) RITUXIMAB (6,587) PREGABALIN (6,320) PREDNISONE (6,319) ABATACEPT (6,251)

Which IVACAFTOR Alternatives Have Lower Malaise Risk?

IVACAFTOR vs IVACAFTOR\LUMACAFTOR IVACAFTOR vs IVACAFTOR\TEZACAFTOR IVACAFTOR vs IVERMECTIN IVACAFTOR vs IVOSIDENIB IVACAFTOR vs IXABEPILONE

Related Pages

IVACAFTOR Full Profile All Malaise Reports All Drugs Causing Malaise IVACAFTOR Demographics