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What the label lists and what reports show

Droperidol side effects

Droperidol's FDA label: “The most common somatic adverse reactions reported to occur with droperidol are mild to moderate hypotension and tachycardia, but these effects usually subside without treatment.” FAERS holds 1,613 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 anaphylactic shock (92 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the droperidol FDA label on DailyMed (effective June 8, 2022, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common somatic adverse reactions reported to occur with droperidol are mild to moderate hypotension and tachycardia, but these effects usually subside without treatment.

From the label: adverse reactions, continued

QT interval prolongation, torsade de pointes, cardiac arrest, and ventricular tachycardia have been reported in patients treated with droperidol. Some of these cases were associated with death. Some cases occurred in patients with no known risk factors, and some were associated with droperidol doses at or below recommended doses. Physicians should be alert to palpitations, syncope, or other symptoms suggestive of episodes of irregular cardiac rhythm in patients taking droperidol and promptly evaluate such cases (see WARNINGS , Effects on Cardiac Conduction ). The most common somatic adverse reactions reported to occur with droperidol are mild to moderate hypotension and tachycardia, but these effects usually subside without treatment. If hypotension occurs and is severe or persists, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy. The most common behavioral adverse effects of droperidol include dysphoria, postoperative drowsiness, restlessness, hyperactivity and anxiety, which can either be the result of an inadequate dosage (lack of adequate treatment effect) or of an adverse drug reaction (part of the symptom complex of akathisia). Care should be taken to search for extrapyramidal signs and symptoms (dystonia, akathisia, oculogyric crisis) to differentiate these different clinical conditions. …

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective June 8, 2022 (SPL set d89f33ac-8a6e-49e7-94fb-84e58aad65a8), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,613 reports list droperidol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 189 are coded as a death and 686 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 20 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.

Reports received each year

The 25 most reported reactions

  • Vomiting (a use or a product term, not a reaction)101
  • Nausea (a use or a product term, not a reaction)99
  • Anaphylactic Shock92
  • Drug Interaction (a use or a product term, not a reaction)90
  • Hypotension (named in the label)82
  • Restlessness (named in the label)77
  • Off Label Use (a use or a product term, not a reaction)71
  • Cardiac Arrest (named in the label)60
  • Drug Ineffective (a use or a product term, not a reaction)60
  • Anaphylactic Reaction58
  • Fatigue57
  • Tachycardia (named in the label)55
  • Dyspnoea54
  • Drug Hypersensitivity52
  • Anxiety (named in the label)51
  • Sepsis50
  • Back Pain47
  • C-Reactive Protein Increased46
  • Pain45
  • Brain Oedema44
  • Candida Infection44
  • Pleural Effusion44
  • Pseudomonal Sepsis43
  • Rash43
  • Streptococcal Sepsis43

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

What next?

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