Gamma-aminobutyric acid

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Gamma-aminobutyric acid is an anxiolytic that is FDA approved for the treatment of epilepsy.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional.  If symptoms persist, consult your health care professional.  - Consult a physician for use in children under 12 years of age.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gamma-aminobutyric acid in adult patients.

### NonGuideline-Supported Use
- Epilepsy, tardive dyskinesia, spasicity

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Gamma-aminobutyric acid in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Gamma-aminobutyric acid in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Gamma-aminobutyric acid in pediatric patients.

# Contraindications
- Hypersensitivity to GABA

# Warnings
- WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Gamma-aminobutyric acid in the drug label.

## Postmarketing Experience
- Visual defects with vigabatrin administration.
- Flushing, euphoria, anxiety.
- Increased blood pressure and heart rate.

# Drug Interactions
There is limited information regarding Gamma-aminobutyric acid Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Gamma-aminobutyric acid in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Gamma-aminobutyric acid during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Gamma-aminobutyric acid with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Gamma-aminobutyric acid in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Gamma-aminobutyric acid in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Gamma-aminobutyric acid in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Gamma-aminobutyric acid in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of Gamma-aminobutyric acid in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Gamma-aminobutyric acid in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Gamma-aminobutyric acid in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Gamma-aminobutyric acid Mechanism of Action in the drug label.

## Structure
There is limited information regarding Gamma-aminobutyric acid Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Gamma-aminobutyric acid in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Gamma-aminobutyric acid in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Gamma-aminobutyric acid in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Gamma-aminobutyric acid in the drug label.

# How Supplied
There is limited information regarding Gamma-aminobutyric acid How Supplied in the drug label.

## Storage
There is limited information regarding Gamma-aminobutyric acid Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of Gamma-aminobutyric acid in the drug label.

# Precautions with Alcohol
- Alcohol-Gamma-aminobutyric acid interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- GABA PHENOLIC 

# Look-Alike Drug Names
There is limited information regarding Gamma-aminobutyric acid Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price