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What the label lists and what reports show

Milrinone side effects

Milrinone's FDA label lists its adverse reactions in its own words. FAERS holds 271 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypotension (16 reports).

  • Generic listed

Check it at the source: the milrinone FDA label on DailyMed (effective June 13, 2026, Shandong New Time Pharmaceutical Co., Ltd.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Cardiovascular Effects In patients receiving milrinone lactate in Phase II and III clinical trials, ventricular arrhythmias were reported in 12.1%: Ventricular ectopic activity, 8.5%; nonsustained ventricular tachycardia, 2.8%; sustained ventricular tachycardia, 1% and ventricular fibrillation, 0.2% (2 patients experienced more than one type of arrhythmia). Holter recordings demonstrated that in some patients injection of milrinone lactate increased ventricular ectopy, including nonsustained ventricular tachycardia. Life-threatening arrhythmias were infrequent and when present have been associated with certain underlying factors such as preexisting arrhythmias, metabolic abnormalities (e.g. hypokalemia), abnormal digoxin levels and catheter insertion. Milrinone lactate was not shown to be arrhythmogenic in an electrophysiology study. …

Source: FDA drug label, Shandong New Time Pharmaceutical Co., Ltd., effective June 13, 2026 (SPL set 0fdaee3c-2144-4ca7-9868-54d251f468c0), via openFDA; the full label on DailyMed

What do FAERS reports show?

271 reports list milrinone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 49 are coded as a death and 98 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)89
  • Hypotension (named in the label)16
  • Renal Failure13
  • Cardiac Failure12
  • Dyspnoea11
  • Cardiac Arrest10
  • Off Label Use (a use or a product term, not a reaction)10
  • Ventricular Tachycardia (named in the label)10
  • Haemorrhage9
  • Multi-Organ Failure9
  • Nausea9
  • Respiratory Failure9
  • Cardiac Failure Congestive8
  • Cardiogenic Shock8
  • Pain8
  • Renal Failure Acute8
  • Death (an outcome recorded in the report)7
  • Injury7
  • Pneumonia7
  • Pyrexia7
  • Shock (named in the label)7
  • Tachycardia (named in the label)7
  • Cardiac Disorder6
  • Chest Pain (named in the label)6
  • General Physical Health Deterioration6

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Milrinone: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions