Pixab 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

The safety of Apixaban has been investigated in 7 Phase III clinical studies including more than 21,000 patients: more than 5,000 patients in venous thromboembolic event prevention (VTEp) studies, more than 11,000 patients in non-valvular atrial fibrillation (NVAF) studies and more than 4,000 patients in the venous thromboembolic event treatment (VTEt) studies, for an average total exposure of 20 days, 1.7 years and 221 days respectively.
Table as follows shows the adverse reactions ranked under headings of system organ class and frequency using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data) for VTEp, NVAF, and VTEt respectively. (See table).

Click on icon to see table/diagram/image

View ADR Reporting Link

apixaban

Manufacturer:

Intas

Distributor:

Oxpharm

Marketer:

One Dexcel Pharma