Anoro Ellipta Adverse Reactions

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Full Prescribing Info

Adverse Reactions

Clinical trial data: The safety profile of Umeclidinium + Vilanterol (Anoro Ellipta) is based on approximately 3000 patients with COPD who received doses of umeclidinium/vilanterol 62.5/25 micrograms or greater for up to one year during clinical studies. This includes approximately 1600 patients who received 62.5/25 micrograms and approximately 1300 patients who received 125/25 micrograms, both once daily.
Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000). (See Table 3.)

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Post-marketing data: See Table 4.

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Anoro Ellipta Adverse Reactions

umeclidinium + vilanterol

Manufacturer:

GlaxoSmithKline

Distributor:

GlaxoSmithKline