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Adverse Event

Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which may or may not have a causal relationship with this treatment.

Additional safety information includes (but is not limited to) the following report types:

  • Unapproved or off-label use
  • Use during pregnancy
  • Exposure to a drug during breast-feeding / lactation
  • Overdose (whether intentional, accidental or prescribed)
  • Drug abuse or misuse
  • Medication errors
  • Drug-drug interactions
  • Drug-food interactions
  • Lack of therapeutic effect