The most commonly reported side effects of roflumilast include dyspnoea, death, and chronic obstructive pulmonary disease, based on 6,989 FDA adverse event reports from 2004 to 2025. 5.0% of reports found the drug to be ineffective.
Percentages show how often each reaction appears relative to total reports for roflumilast.
These are voluntary reports and do not establish that roflumilast caused these reactions.
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Other drugs that appear in adverse event reports alongside roflumilast. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.
Also suspected
Taken alongside
Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.
47.6% of roflumilast adverse event reports involve female patients and 41.6% involve male patients. The largest age group is elderly at 64%. These figures reflect who reports side effects, not underlying risk.
Sex
Age group
Conditions and purposes for which patients were taking roflumilast when the adverse event was reported.
Showing 15 of 154 indications
Roflumilast is sold under the brand name Zoryve.
An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.
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