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Phenobarbital sodium

Generic Name: phenobarbital (FEE noe BAR bi tal)
Brand Name: Solfoton, Luminal
Physician reviewed phenobarbital patient information - includes phenobarbital description, dosage and directions.
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Drug Information:
Phenobarbital is a barbiturate (bar-BIT-chur-ate). Phenobarbital slows the activity of your brain and nervous system. Phenobarbital is used to treat or prevent seizures. Phenobarbital is also used short-term as a sedative to help you relax. Phenobarbital may also be used for purposes not listed in this medication guide. You should not use phenobarbital if you have severe liver disease, severe asthma or COPD, a personal or family history of porphyria, or a history of addiction to drugs similar to phenobarbital. Learn more

Phenobarbital sodium Side Effects

Phenobarbital Side Effects

For the Consumer

Applies to phenobarbital: oral elixir, oral tablets, parenteral injection

Side effects include:

Residual sedation, drowsiness, lethargy, vertigo, nausea, vomiting, headache.

For Healthcare Professionals

Applies to phenobarbital: compounding powder, injectable solution, oral capsule, oral elixir, oral tablet

General

The most commonly reported side effect was somnolence.

Nervous system

Common (1% to 10%): Somnolence

Postmarketing reports: Sedation, residual sedation/"hangover" effect, drowsiness, lethargy, vertigo, localized/diffuse neuralgic pain, headache, hyperactivity, hypotension, hyperkinesia, ataxia, central nervous system (CNS) depression, dizziness, impairment of fine motor skills, Grand mal convulsion, prolonged coma, depressed/absent reflexes, nystagmus

Drowsiness/sedation tended to decrease with continued use.

Localized or diffuse neuralgic pain occurred, especially in psychoneurotic patients with insomnia. This pain was most frequently located in the neck, shoulders, and upper limbs and appeared in paroxysms that were most intense early in the morning. In some patients, the pain continued for days after discontinuation of this drug.

Hyperactivity occurred in pediatric and geriatric patients.

Psychiatric

Postmarketing reports: Accentuated emotional disturbances/phobias, aggression, excitement/hyperexcitability, restlessness, delirium, irritability, agitation, confusion, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia/sleep disturbance, anxiety, abnormality in thinking, paradoxical reaction (unusual excitement), mental depression/depression, cognitive impairment, behavioral disturbances in children, abnormal behavior, mood altered, subtle mood changes, menstrually related mood disorder, suicidal ideation, memory/concentration/judgment impairment, withdrawal syndrome, tolerance, dependence, psychic/physical dependence, mental confusion/confusion, disorientation

Some patients have experienced paradoxical excitement, restlessness, or delirium in the presence of pain.

Paradoxical reactions, hallucinations, restlessness, hyperexcitability, and confusion have occurred in geriatric and pediatric patients. Pediatric patients were more likely to experience aggression or irritability.

Immunologic

Postmarketing reports: Antiepileptic hypersensitivity syndrome (e.g., fever, rash, lymphadenopathy, lymphocytosis, eosinophilia, hematological abnormalities, hepatic and other organ involvement [renal, pulmonary])

Antiepileptic hypersensitivity syndrome typically occurred 1 to 8 weeks after first exposure or within 1 day of rechallenge. This syndrome may have cross reactivity with other antiepileptic agents.

Dermatologic

Skin eruptions may be associated with fever, delirium, and marked changes in the liver and other organs.

Postmarketing reports: Erythematous dermatitis, exfoliative dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), skin eruptions, maculopapular/morbilliform/scarlatiniform rashes, dermatitis, erythema multiforme, drug eruption, evidence of connective tissue changes, skin blisters/bullae, photosensitivity, erythroderma, urticaria

Musculoskeletal

Postmarketing reports: Localized/diffuse myalgic or arthritic pain, osteomalacia, rickets, decreased bone mineral density, increased risk of fracture, Dupuytren's contracture, bone metabolism disorder, frozen shoulder, Ledderhose's syndrome, general joint pain, osteopenia, osteoporosis, fractures

Localized or diffuse myalgic or arthritic pain occurred, especially in psychoneurotic patients with insomnia. This pain was most frequently located in the neck, shoulders, and upper limbs and appeared in paroxysms that were most intense early in the morning. In some patients, pain continued for days after discontinuation of therapy.

Decreased bone mineral density, Dupuytren's contracture, osteopenia, osteoporosis, and fractures occurred in patients receiving long-term therapy; however, the exact mechanism of action in bones was not identified.

Other

Postmarketing reports: Inebriation (drunk-like effect), fever, neonatal sedation, neonatal drug dependence/withdrawal, neonatal symptoms resembling vitamin K deficiency, neonatal bleeding due to vitamin K deficiency, congenital anomaly, cleft lip and palate, lowered body temperature

Hematologic

Postmarketing reports: Megaloblastic anemia, macrocytic anemia, aplastic anemia, agranulocytosis, thrombocytopenia, hypoprothrombinemia, methemoglobinemia, purpura, lymphocytosis

Megaloblastic anemia occurred after chronic use of this drug, and may be due to folate deficiency.

Methemoglobinemia has occurred in infants nursed by mothers receiving this drug.

Cardiovascular

Postmarketing reports: Circulatory collapse, peripheral vascular collapse, weak heartbeat, circulatory failure, bradycardia, hypotension, profound shock, vasodilation

Respiratory

Postmarketing reports: Respiratory depression, severe/significant respiratory depression, apnea, hypoventilation, bronchospasm, laryngospasm

Bronchospasm and laryngospasm were reported, especially in patients given the IV formulation.

Hepatic

Postmarketing reports: Abnormal hepatic function, hepatitis, liver damage, cholestasis, toxic hepatitis, jaundice

Metabolic

Postmarketing reports: Hypocalcemia, folate deficiency, abnormal vitamin D metabolism, increased vitamin D requirements (possibly resulting from abnormal vitamin D metabolism), vitamin K deficiency, hypophosphatemia

Gastrointestinal

Postmarketing reports: Nausea, vomiting, constipation, diarrhea

Hypersensitivity

Hypersensitivity reactions generally consisted of acquired hypersensitivity. Patients with a higher risk of developing reactions were more likely to have asthma, urticaria, and angioedema.

Postmarketing reports: Localized swelling (e.g. eyelids, cheeks, lips), hypersensitivity reactions (e.g., angioedema, skin rashes, exfoliative dermatitis), angioedema

Local

Postmarketing reports: Injection site reactions, local necrosis after extravasation (IV/subcutaneous injection)

Renal

Postmarketing reports: Renal failure

Oncologic

Postmarketing reports: Fibromas

Endocrine

Postmarketing reports: Reduced serum concentrations of thyroid hormones

Genitourinary

Postmarketing reports: Peyronie's disease

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Phenobarbital Sodium