Romazicon Side Effects

Generic Name: flumazenil

Please note - some side effects for Romazicon 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 Romazicon - for the Consumer

Romazicon

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 Romazicon:

Abnormal or blurred vision; abnormal skin sensations; changes in vision; clumsiness; dizziness; dry mouth; feeling of a whirling motion; flushing; general body discomfort; headache; hot flashes; increased sweating; nausea; nervousness; pain at the injection site; restlessness; sleeplessness; sweating; tiredness; tremors; vomiting; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in behavior, mood, or emotions (eg, anxiety, depression); pounding in the chest; rapid deep breathing; seizures.

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.

Romazicon Side Effects - for the Professional

Romazicon

Serious Adverse Reactions
Deaths have occurred in patients who received Romazicon in a variety of clinical settings. The majority of deaths occurred in patients with serious underlying disease or in patients who had ingested large amounts of non-benzodiazepine drugs (usually cyclic antidepressants), as part of an overdose. Serious adverse events have occurred in all clinical settings, and convulsions are the most common serious adverse events reported. Romazicon administration has been associated with the onset of convulsions in patients with severe hepatic impairment and in
patients who are relying on benzodiazepine effects to control seizures, are physically dependent on benzodiazepines, or who have ingested large doses of other drugs (mixed-drug overdose). Two of the 446 patients who received Romazicon in controlled clinical trials for the management of a benzodiazepine overdose had cardiac dysrhythmias (1 ventricular tachycardia, 1 junctional tachycardia).

Adverse Events in Clinical Studies
The following adverse reactions were considered to be related to Romazicon administration (both alone and for the reversal of benzodiazepine effects) and were reported in studies involving 1875 individuals who received flumazenil in controlled trials. Adverse events most frequently associated with flumazenil alone were limited to dizziness, injection site pain, increased sweating, headache, and abnormal or blurred vision (3% to 9%).
Body as a Whole: fatigue (asthenia, malaise), headache, injection site pain1, injection site reaction (thrombophlebitis, skin abnormality, rash)
Cardiovascular System: cutaneous vasodilation (sweating, flushing, hot flushes)
Digestive System: nausea, vomiting (11%)
Nervous System: agitation (anxiety, nervousness, dry mouth, tremor, palpitations, insomnia, dyspnea, hyperventilation)1, dizziness (vertigo, ataxia) (10%), emotional lability (crying abnormal, depersonalization, euphoria, increased tears, depression, dysphoria, paranoia)
Special Senses: abnormal vision (visual field defect, diplopia), paresthesia (sensation abnormal, hypoesthesia)
All adverse reactions occurred in 1% to 3% of cases unless otherwise marked.
Observed percentage reported if greater than 9%.
The following adverse events were observed infrequently (less than 1%) in the clinical studies, but were judged as probably related to Romazicon administration and/or reversal of benzodiazepine effects:
Nervous System: confusion (difficulty concentrating, delirium), convulsions, somnolence (stupor)
Special Senses: abnormal hearing (transient hearing impairment, hyperacusis, tinnitus)
The following adverse events occurred with frequencies less than 1% in the clinical trials. Their relationship to Romazicon administration is unknown, but they are included as alerting information for the physician.
Body as a Whole: rigors, shivering
Cardiovascular System: arrhythmia (atrial, nodal, ventricular extrasystoles), bradycardia, tachycardia, hypertension, chest pain
Digestive System: hiccup
Nervous System: speech disorder (dysphonia, thick tongue)
Not included in this list is operative site pain that occurred with the same frequency in patients receiving placebo as in patients receiving flumazenil for reversal of sedation following a surgical procedure.
1indicates reaction in 3% to 9% of cases.

Additional Adverse Reactions Reported During Postmarketing Experience
The following events have been reported during postapproval use of Romazicon.
Nervous System: Fear, panic attacks in patients with a history of panic disorders.
Withdrawal symptoms may occur following rapid injection of Romazicon in patients with long-term exposure to benzodiazepines.

Side Effects by Body System - for Healthcare Professionals

General

Flumazenil is generally well-tolerated when given to patients without prior exposure to benzodiazepines. Convulsions are the most common serious adverse events reported. Dizziness, injection site pain, increased sweating, headache, and visual disturbances have been reported in 3% to 9% of patients. Most of the adverse effects observed during flumazenil therapy are related to the rapid resolution of benzodiazepine effects rather than to the administration of flumazenil per se.

Nervous system

Flumazenil has been associated with seizures in patients with severe hepatic insufficiency and patients who were taking benzodiazepines for seizure control. Other risk factors for seizures may include concurrent sedative-hypnotic withdrawal, recent repeated administration of parenteral benzodiazepines, jerking or seizures prior to administration of flumazenil, and concurrent cyclic antidepressant overdose.

Seizures are generally reversible with standard antiepileptic therapy include benzodiazepines, phenytoin or barbiturates. Greater than usual benzodiazepine doses may be required to control seizures which occur in association with flumazenil therapy.

Some investigators have suggested that flumazenil may increase intracranial pressure and should therefore be avoided in patients with space-occupying intracranial lesions.

Nervous system side effects have included seizures, agitation, anxiety, nervousness, dry mouth, tremor, palpitations, insomnia, dyspnea, hyperventilation, dizziness, vertigo, ataxia, confusion, somnolence, resedation (as flumazenil's effects wane), headache, and paresthesia have also been reported.

Psychiatric

Fear and panic attacks have been reported in patients with a history of panic disorders.

Psychiatric side effects have included emotional lability (crying, depersonalization, euphoria, depression, dysphoria, and paranoia), psychosis, anxiety, fear, and panic attacks.

Local

Local reaction at the site of intravenous injection include pain, burning, swelling, and rash.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting in 11% of treated patients. Hiccups have been reported in less than 1%.

Cardiovascular

Cardiovascular side effects have included cutaneous vasodilation (sweating, flushing, and hot flashes) in 1% to 3% of patients. Arrhythmias (atrial, nodal, ventricular extrasystoles), tachycardia, bradycardia, premature ventricular depolarizations, heart block, cardiac arrest, hypertension, and chest pain have been reported in less than 1% of patients.

Ventricular tachycardia (1/446) and junctional tachycardia (1/446) have been reported in clinical trials of patients with benzodiazepine overdose.

Some investigators have suggested that reports of adverse cardiac effects are related to reversal of benzodiazepine-mediated sedation with consequent increased sympathetic drive, rather than to any intrinsic cardiac effects of flumazenil.

Other investigators and case reports have suggested that cardiovascular effects are most likely to occur in the setting of multiple drug overdose treated with flumazenil rather than isolated benzodiazepine overdose.

Other

Fatalities have been reported, the majority of deaths were in patients with overdoses due to nonbenzodiazepine drugs (usually cyclic antidepressants) and in patients with serious underlying disease.

Other

Benzodiazepine withdrawal symptoms have been reported following flumazenil treatment in patients receiving chronic (and rarely, acute) benzodiazepine therapy. Such symptoms have included dizziness, tenseness, agitation, anxiety, panic attacks, confusion, tachycardia, perceptual disturbances, and sweating. Withdrawal symptoms may occur in chronic benzodiazepine users after rapid flumazenil injection.

Although benzodiazepine withdrawal symptoms have been reported, symptoms are generally mild and transient. One study has reported that no evidence of precipitated withdrawal was observed on psychomotor/behavioral performance studies or observer ratings in subjects pretreated with benzodiazepines.

Another case report has suggested that flumazenil may aggravate seizures in patients undergoing benzodiazepine withdrawal.

Other

Other side effects affecting the body as a whole have included fatigue, rigors, and shivering.

Other

Tinnitus, hyperacusis, transient hearing impairment, dysphonia, and thick tongue have been reported.

Ocular

Ocular side effects have included abnormal vision, diplopia, and visual field defects.

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