IMPORTANT SAFETY INFORMATION
- Contraindications: ELMIRON® is contraindicated in patients with known hypersensitivity to the drug, structurally related compounds, or excipients.
- Anticoagulant Activity: ELMIRON® is a weak anticoagulant (blood thinner) which may increase bleeding. Patients undergoing invasive surgery or having signs/symptoms of underlying coagulopathy or other increased risk of bleeding (due to anticoagulant therapy or high doses of anti-inflammatory drugs) should be evaluated for the risk of hemorrhage.
- Alopecia: In clinical trials of ELMIRON®, alopecia began within the first 4 weeks of treatment. Ninety-seven percent (97%) of the cases of alopecia reported were alopecia areata, limited to a single area on the scalp.
- Use in Pregnancy: ELMIRON® is a Pregnancy Category B drug.
- Most Common Adverse Reactions (frequency 1% to 4%): Alopecia (4%), diarrhea (4%), nausea (4%), headache (3%), rash (3%), dyspepsia (2%), abdominal pain (2%), liver function abnormalities (1%), and dizziness (1%).
Please see full Prescribing Information for ELMIRON®.