Flumazenil Solution For Injection 0.1Mg Drug Medication Dosage Information
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Flumazenil: Solution for injection (0.1mg)

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What is this Medicine?

FLUMAZENIL helps to reverse the effects of certain sedative drugs called benzodiazepines. Examples include diazepam, alprazolam, and many others. It is often used following a medical procedure where sedative drugs have been used. It is also used as an antidote after a drug overdose.

In-Depth Information
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Flumazenil 0.5mg/5mL Solution for Injection

NDC: 001439784
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Benzodiazepine Toxicity, Sedation Reversal

Storage Information
Discard product if it contains particulate matter, is cloudy, or discolored
Store at 77 degrees F; excursions permitted to 59-86 degrees F
Flumazenil 0.5mg/5mL Solution for Injection

Reported Side Effects for Flumazenil 0.5mg/5mL Solution for Injection

Hyperacusis Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Hiccups Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Deafness Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Ringing In Ears Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
High Blood Pressure Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Confusion Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Drowsiness Incidence:
<1.0%*
Severity: MILD
Onset: EARLY
Shivering Incidence:
<1.0%*
Severity: MILD
Onset: RAPID
Delirium Incidence:
<1.0%*
Severity: MODERATE
Onset: EARLY
Slow Heart Beat Incidence:
<1.0%*
Severity: SEVERE
Onset: RAPID
Rapid Heart Rate Incidence:
<1.0%*
Severity: MODERATE
Onset: RAPID
Hoarseness Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Emotional Lability Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Elated Mood Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: EARLY
Dysphoria Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: EARLY
Flushing Incidence:
1.0-3.0%*
Severity: MILD
Onset: RAPID
Hypoesthesia Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Injection Site Reaction Incidence:
1.0-3.0%*
Severity: MILD
Onset: RAPID
Feeling Sick Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Paranoia Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Peripheral Vasodilation Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: RAPID
Irritated Blood Vessels Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: RAPID
Skin Rash Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Double Vision Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: DELAYED
Weakness Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
1.0-9.0%*
Severity: MILD
Onset: EARLY
Hot Flashes Incidence:
1.0-3.0%*
Severity: MODERATE
Onset: EARLY
Distressed Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Nervousness Incidence:
3.0-9.0%*
Severity: MILD
Onset: DELAYED
Shortness Of Breath Incidence:
3.0-9.0%*
Severity: MODERATE
Onset: EARLY
Excessive Sweating Incidence:
3.0-9.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
3.0-9.0%*
Severity: MODERATE
Onset: EARLY
Inability To Sleep Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Shaking Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Balance Problems Incidence:
3.0-10.0%*
Severity: MILD
Onset: EARLY
Overbreathing Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Dry Mouth Incidence:
3.0-9.0%*
Severity: MILD
Onset: EARLY
Incoordination Incidence:
3.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Blurred Vision Incidence:
3.0-9.0%*
Severity: MODERATE
Onset: EARLY
Lightheadedness Incidence:
3.0-10.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
11.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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