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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 ROFLUMILAST Cause Malaise? 164 Reports in FDA Database

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According to the FDA Adverse Event Reporting System (FAERS), 164 reports of Malaise have been filed in association with ROFLUMILAST (ROFLUMILAST). This represents 6.1% of all adverse event reports for ROFLUMILAST.

164
Reports of Malaise with ROFLUMILAST
6.1%
of all ROFLUMILAST reports
6
Deaths
48
Hospitalizations

How Dangerous Is Malaise From ROFLUMILAST?

Of the 164 reports, 6 (3.7%) resulted in death, 48 (29.3%) required hospitalization, and 3 (1.8%) 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 ROFLUMILAST. However, 164 reports have been filed with the FAERS database.

What Other Side Effects Does ROFLUMILAST Cause?

Death (569) Dyspnoea (433) Chronic obstructive pulmonary disease (292) Diarrhoea (265) Off label use (242) Weight decreased (224) Nausea (191) Pneumonia (176) Headache (166) Asthma (158)

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 ROFLUMILAST Alternatives Have Lower Malaise Risk?

ROFLUMILAST vs ROLAPITANT ROFLUMILAST vs ROMIDEPSIN ROFLUMILAST vs ROMIPLOSTIM ROFLUMILAST vs ROMOSOZUMAB ROFLUMILAST vs ROMOSOZUMAB-AQQG

Related Pages

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