Romazicon Side Effects

Generic name: flumazenil

Medically reviewed by Drugs.com. Last updated on Jun 10, 2024.

Note: This document provides detailed information about Romazicon.

Applies to flumazenil: parenteral injection Side Effects associated with flumazenil. Some dosage forms listed on this page may not apply specifically to the brand name Romazicon.

Applies to flumazenil: parenteral injection.

Side effects include:

Dizziness, injection site pain, increased sweating, headache, and abnormal or blurred vision.

For healthcare professionals

Applies to flumazenil: intravenous solution.

Nervous system adverse events

• Very common (10% or more): Dizziness (vertigo, ataxia) (10%)
• Common (1% to 10%): Headache, paresthesia (sensation abnormal, hypoesthesia)
• Frequency not reported: Convulsions, somnolence, speech disorder (dysphonia, thick tongue)^[Ref]

Convulsions have occurred in patients with severe hepatic impairment, inpatients relying on benzodiazepine effects to control seizures, patients physically dependent on benzodiazepines, and those who have ingested large doses of other drugs (mixed-drug overdose).^[Ref]

Psychiatric

• Common (1% to 10%): Agitation (anxiety, nervousness, dry mouth, tremor, palpitations, insomnia, dyspnea, hyperventilation), emotional lability (crying abnormal, depersonalization, euphoria, increased tears, depression, dysphoria, paranoia)
• Frequency not reported: Confusion (difficulty concentrating, delirium)
• Postmarketing reports: Fear, panic attacks in patients with a history of panic disorders^[Ref]

Cardiovascular

• Common (1% to 10%): Cutaneous vasodilation (sweating, flushing, hot flushes)
• Uncommon (0.1% to 1%): Cardiac dysrhythmias (ventricular tachycardia, junctional tachycardia)
• Frequency not reported: Arrhythmia (atrial, nodal, ventricular extrasystoles), bradycardia, tachycardia, hypertension, chest pain^[Ref]

Other

• Common (1% to 10%): Fatigue (asthenia, malaise)
• Frequency not reported: Death, abnormal hearing (transient hearing impairment, hyperacusis, tinnitus), rigors, shivering
• Postmarketing reports: Withdrawal symptoms^[Ref]

The majority of deaths occurred in patients with serious underlying disease or in patients who had injects large amounts of non-benzodiazepine drugs (usually cyclic antidepressants) as part of an overdose.

Withdrawal symptoms may occur after rapid injection of flumazenil in patients with long term exposure to benzodiazepines.^[Ref]

Local

• Common (1% to 10%): Injection site pain, injection site reaction (thrombophlebitis, skin abnormality, rash)^[Ref]

Ocular

• Common (1% to 10%): Abnormal vision (visual field defect, diplopia)^[Ref]

Respiratory

• Frequency not reported: Hiccup^[Ref]

See also:

Further information

Romazicon side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer