Droperidol Side Effects

Brand Names: Inapsine

Please note - some side effects for Droperidol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Droperidol - for the Consumer

Droperidol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Droperidol:

Anxiety; drowsiness; hyperactivity; restlessness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty speaking and swallowing; dizziness; fainting; fast heartbeat; hallucinations; headache; lightheadedness; loss of balance; pounding in the chest; twitching of the face or tongue; uncontrolled movements of arms and legs.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Droperidol Side Effects - for the Professional

Droperidol

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.

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. When extrapyramidal symptoms are the cause, they can usually be controlled with anticholinergic agents.

Postoperative hallucinatory episodes (sometimes associated with transient periods of mental depression) have also been reported.

Other less common reported adverse reactions include anaphylaxis, dizziness, chills and/or shivering, laryngospasm and bronchospasm.

Elevated blood pressure, with or without pre-existing hypertension, has been reported following administration of Droperidol combined with fentanyl citrate or other parenteral analgesics. This might be due to unexplained alterations in sympathetic activity following large doses; however, it is also frequently attributed to anesthetic or surgical stimulation during light anesthesia.

Side Effects by Body System - for Healthcare Professionals

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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