Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients.
Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
Nervous System Somnolence, agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality Respiratory System Hypoventilation, apnea Cardiovascular System Bradycardia, hypotension, syncope Digestive System Nausea, vomiting, constipation Dermatologic Reactions Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermic necrolysis.
Other Reported Reactions Headache;
injection site reactions;
hypersensitivity reactions, including but not limited to angioedema and skin rashes;
liver damage and megaloblastic anemia following chronic phenobarbital use.
WARNINGS Phenobarbital Sodium Injection contains the preservative benzyl alcohol and is not recommended for use in neonates.
There have been reports of fatal 'gasping syndrome' in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol.
Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse.
Habit Forming Barbiturates may be habit forming.
Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE and CLINICAL PHARMACOLOGY ).
Like all medications, Phenobarbital Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: