Secobarbital

Teratogenic Effects

Pregnancy Category D.

Nonteratogenic Effects

Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days.

Caution should be exercised when secobarbital is administered to a nursing woman, because small amounts of barbiturates are excreted in the milk.

Secobarbital may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.

The following adverse reactions and their incidences were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of some of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.

More than 1 in 100 Patients

The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is the following:

Nervous System: Somnolence

Less than 1 in 100 Patients

Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence:

Nervous System: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinking

Respiratory System: Hypoventilation, apnea

Cardiovascular System: Bradycardia, hypotension, syncope

Digestive System: Nausea, vomiting, constipation

Other Reported Reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use