Nembutal Side Effects

Please note - some side effects for Nembutal may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Nembutal Side Effects - for the Professional

Nembutal

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.

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:
Nervous System: Somnolence.

Less than 1 in 100 patients. Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are:
Nervous system: 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.
Other reported reactions: Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use.

To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects have been common and have included drowsiness, sedation, lethargy, and somnolence. Paradoxical stimulation has also been reported in the elderly.

Behavioral problems, impaired memory, impaired cognition, decreased perceptuomotor performance, tics, dyskinesias, nystagmus, oculogyric crises, dystonic reactions, and ataxia have also been reported.

Respiratory

Respiratory side effects including life threatening respiratory depression have been reported, particularly during acute intoxication.

Other

Other side effects from pentobarbital use have included physical and psychological dependence. Withdrawal symptoms have been reported when pentobarbital therapy has been discontinued suddenly.

Withdrawal symptoms may include hallucinations, sweating, insomnia, and hypertension.

An increased frequency of seizures may occur if barbiturate therapy is suddenly discontinued.

Cardiovascular

Cardiovascular side effects including hypotension and bradycardia have been reported.

Musculoskeletal

Musculoskeletal side effects including myopathy in association with anticonvulsant osteomalacia has been reported in patients taking other barbiturates. Reflex sympathetic dystrophy of the upper extremities, Dupuytren's contractures, Peyronie's disease, the "shoulder-hand syndrome" and other musculoskeletal and joint pains have been reported in as many as 5% of patients treated with other barbiturates.

Hypersensitivity

Hypersensitivity side effects have included a variety of hypersensitivity reactions reported in association with use of pentobarbital and other barbiturates. The reactions frequently involved generalized rashes, fever, and hepatic derangements.

Hepatic

The more serious hepatic effects have often been reported in association with hypersensitivity reactions.

Hepatic side effects including elevated liver function tests, hepatitis, cholestasis, and fulminant hepatic failure have all been reported in association with use of other barbiturates.

Hematologic

Hematologic side effects including macrocytosis and, more rarely, megaloblastic anemia have been reported with use of other barbiturates.

Animal studies have suggested that pentobarbital may inhibit prostaglandin l2 and thereby promote platelet aggregation.

Endocrine

Endocrine side effects including alterations in vitamin D metabolism have been reported in patients taking barbiturates and other anticonvulsants. Hypocalcemia and osteomalacia have been specifically reported.

Oncologic

Oncologic side effects have been reported. Some investigators have reported a possible increased frequency of malignancy (particularly brain tumors, lung cancer, and liver cancer) in patients taking pentobarbital and other barbiturates chronically. Other investigators have not found an association with malignancy.

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