Table 3

Cardiovascular reports on evolocumab registered at the FDA Adverse Event Reporting System (FAERS) (as of 30 June 2022)

No reportsFatalSerious
(incl. death)
Cardiac disorders22411371875
 Myocardial infarction65155620
 Heart failure*18912183
Vascular disorders188635991
Nervous system disorders—stroke and TIA64133622
 Stroke†54131526
 Transient ischaemic accident (TIA)100296
 Stroke+TIA64133622
Cardiovascular disorders‡47682053488
Total adverse event reports (all reaction groups)89 366113214 986
CV events out of total adverse events5.3%18.1%23.3%
  • *Cardiac failure congestive, cardiac failure, cardiac failure acute, cardiac dysfunction, cardiac failure chronic.

  • †Cerebrovascular accident, cerebral infarction, cerebral haemorrhage, haemorrhagic stroke, subaracnoid haemorrhage, ischaemic stroke, haemorrhage intracraneal, cerebral thrombosis, embolic stroke, haemorrhagic cerebral infarction, cerebral venous thrombosis, cerebral artery thrombosis, brain stem stroke, brain stem infarction, brain stem haemorrhage, lacunar stroke, lacunar infarction, thrombotic stroke, basilar artery thrombosis, stroke in evolution and embolic cerebral infarction.

  • ‡Cardiac disorders, vascular disorders, stroke and transient ischaemic accident.