aclidinium

What the FDA Data Shows for aclidinium

The FDA label for aclidinium (sold under brand names such as Tudorza Pressair) classifies it as a prescription-only medication in the Long-Acting Muscarinic Antagonist (LAMA) class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 3 commonly reported side effects, including Upper respiratory infection, Headache, Back pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 9,070 voluntary reports. The database also lists 1 documented drug interaction derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.