Droperidol Side Effects

Some side effects of droperidol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to droperidol: injectable solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking droperidol: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• feeling like you might pass out;

• dizziness, fainting, fast or pounding heartbeat, fluttering in your chest;

• chest tightness and trouble breathing;

• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

• confusion, hallucinations;

• tremor (uncontrolled shaking); or

• restless muscle movements in your eyes, tongue, jaw, or neck.

Less serious side effects include:

• drowsiness, dizziness; or

• feeling restless or anxious.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to droperidol: compounding powder, injectable solution

Cardiovascular

Cardiovascular side effects including cases of QT prolongation, serious arrhythmias (e.g., torsades de pointes), ventricular tachycardia, and cardiac arrest have been reported. Some of these side effects were associated with death. Some of these side effects occurred in patients with no known risk factors, and some were associated with droperidol doses at or below recommended doses. Hypotension and mild to moderate tachycardia have been the most commonly reported somatic adverse events.

A 60-year-old male with no history of cardiac disease experienced ventricular tachycardia leading to coronary artery spasm coincident with droperidol therapy. The patient underwent ileocecectomy to treat ileocecal lymphoma. One and one half hour after the start of surgery, he was given droperidol 1 mg intravenous as prophylaxis for postoperative nausea and vomiting. Within a few minutes, he developed ventricular fibrillation with a torsades de pointes pattern, which subsided after electrical cardioversion. Subsequent monitoring revealed ST segment depression. Twelve-lead electrocardiogram approximately 5 minutes after defibrillation revealed slight ST segment elevation in the inferior limb leads, and increased QTc of 463 ms. The ST segment elevation returned to baseline after several minutes. On day 5 after surgery, the patient underwent cardiac catherization. Coronary angiograms revealed no significant stenosis, but intracoronary injection of 10 mcg ergonovine maleate provoked total obstruction of the middle right coronary artery segment, accompanied by inferior ST segment elevations and polymorphic premature ventricular contractions.

Nervous system

Nervous system side effects including dysphoria, drowsiness, restlessness, hyperactivity, and anxiety have been the most commonly reported behavioral effects. Hallucinations, dizziness, pain, confusion, nervousness, paresthesia, somnolence, tremor, and neuroleptic malignant syndrome have been reported. Extrapyramidal symptoms such as acute dystonia, parkinsonism, akathisia, and oculogyric crisis have been reported in patients receiving droperidol in doses as low as 0.65 mg. In addition, cases of akathisia have been reported in patients during epidural anesthesia. Unexplained fever, alteration of consciousness, extrapyramidal dysfunction, autonomic instability, and elevated creatine kinase have been reported with neuroleptic agents.

Respiratory

Respiratory side effects have included pharyngitis and rhinitis. Bronchospasm and laryngospasm have been less commonly reported.

Hypersensitivity

Hypersensitivity side effects including cases of anaphylaxis have been reported.

Gastrointestinal

Gastrointestinal side effects including sialorrhea, nausea, dry mouth, and anorexia have been reported.

Local

Local side effects including injection site pain and reaction have been reported.

Other

Other side effects including chills and/or shivering and tongue-swelling have been reported occasionally. Asthenia and sweating have also been reported.

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