🇺🇸 Spiolto in United States

546 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Dyspnoea — 124 reports (22.71%)
  2. Chronic Obstructive Pulmonary Disease — 74 reports (13.55%)
  3. Cough — 56 reports (10.26%)
  4. Pneumonia — 53 reports (9.71%)
  5. Death — 49 reports (8.97%)
  6. General Physical Health Deterioration — 47 reports (8.61%)
  7. Nausea — 44 reports (8.06%)
  8. Pyrexia — 36 reports (6.59%)
  9. Fatigue — 32 reports (5.86%)
  10. Cardiac Failure — 31 reports (5.68%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Spiolto approved in United States?

Spiolto does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Spiolto in United States?

Boehringer Ingelheim is the originator. The local marketing authorisation holder may differ — check the official source linked above.