Romazicon Side Effects
Generic Name: flumazenil
Note: This document contains side effect information about flumazenil. Some of the dosage forms listed on this page may not apply to the brand name Romazicon.
For the Consumer
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
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
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 (the active ingredient contained in Romazicon) in patients with long term exposure to benzodiazepines.[Ref]
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]
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]
References
1. Thomas P, Lebrun C, Chatel M "De novo absence status epilepticus as a benzodiazepine withdrawal syndrome." Epilepsia 34 (1993): 355-8
2. LaFleche FR, Milzman DP "Flumazenil & coma." Ann Emerg Med 20 (1991): 1397
3. Marchant B, Wray R, Leach A, Nama M "Flumazenil causing convulsions and ventricular tachycardia." BMJ 299 (1989): 860
4. "Flumazenil." Med Lett Drugs Ther 34 (1992): 66-8
5. Short TG, Galletly DC "Residual psychomotor effects following reversal of midazolam sedation with flumazenil." Anaesth Intensive Care 17 (1989): 290-7
6. Lheureux P, Vrankx M, Askenasi R "Administration of flumazenil." Ann Emerg Med 20 (1991): 592-3
7. "Product Information. Romazicon (flumazenil)." Roche Laboratories, Nutley, NJ.
8. "Product Information. Flumazenil (flumazenil)." Baxter I.V. Systems Division, Round Lake, IL.
9. Chern TL, Kwan A "Flumazenil-induced seizure accompanying benzodiazepine and baclofen intoxication." Am J Emerg Med 14 (1996): 231-2
10. Mordel A, Winkler E, Almog S, Tirosh M, Ezra D "Seizures after flumazenil administration in a case of combined benzodiazepine and tricyclic antidepressant overdose." Crit Care Med 20 (1992): 1733-4
11. Griffiths RR, Evans SM, Guarino JJ, Roache JD, Furman WR, Liebson I, Schwam EM "Intravenous flumazenil following acute and repeated exposure to lorazepam in healthy volunteers: antagonism and precipitated withdrawal." J Pharmacol Exp Ther 265 (1993): 1163-74
12. Seebach J, Jost R "Flumazenil-induced psychotic disorder in hepatic encephalopathy." Lancet 339 (1992): 488-9
13. Birch BR "Cardiac arrest associated with flumazenil." BMJ 305 (1992): 180-1
14. Short TG, Maling T, Galletly DC "Ventricular arrhythmia precipitated by flumazenil." Br Med J (Clin Res Ed) 296 (1988): 1070-1
15. Herd B, Clarke F "Complete heart block after flumazenil." Hum Exp Toxicol 10 (1991): 289
16. Bodenham AR "Death after flumazenil." BMJ 299 (1989): 457
17. Katz Y, Boulos M, Singer P, Rosenberg B "Cardiac arrest associated with flumazenil." BMJ 304 (1992): 1415
18. Lopez A, Rebollo J "Benzodiazepine withdrawal syndrome after a benzodiazepine antagonist." Crit Care Med 18 (1990): 1480-1
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
More about Romazicon (flumazenil)
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- Drug class: antidotes
