Luminal Side Effects

Generic Name: phenobarbital

Note: This page contains information about the side effects of phenobarbital. Some of the dosage forms included on this document may not apply to the brand name Luminal.

Not all side effects for Luminal may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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

Nervous system

Nervous system side effects including drowsiness, sedation, lethargy, somnolence, memory impairment, decreased perceptuomotor performance, and impairment of tasks requiring sustained performance have been reported frequently. Paradoxical stimulation and irritability, behavioral problems, impaired cognition, tics, dyskinesias, periodic alternating nystagmus, oculogyric crises, dystonic reactions, and ataxia have also been reported.[Ref]

Respiratory

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

Other

Withdrawal symptoms may include sweating, insomnia, hallucinations, and hypertension.[Ref]

Other side effects from phenobarbital include physical and psychological dependence. Withdrawal symptoms may occur if phenobarbital therapy is discontinued suddenly. An increased frequency of seizures may also occur if phenobarbital therapy is suddenly discontinued. Dupuytren's contractures have also been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including reflex sympathetic dystrophy of the upper extremities, the "shoulder-hand syndrome", and other musculoskeletal and joint pains have been reported in as many as 5% of patients treated with phenobarbital (the active ingredient contained in Luminal) Myopathy in association with anticonvulsant osteomalacia has also been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including generalized rashes, fever, and hepatic derangements have been reported frequently. Nephritis has also been reported as a consequence of hypersensitivity to phenobarbital (the active ingredient contained in Luminal) A case of a fatal anticonvulsant hypersensitivity syndrome has been reported in an infant.[Ref]

Hepatic

Hepatic side effects including elevated liver function tests, hepatitis, cholestasis, and fulminant hepatic failure have been reported. Mild enzyme elevation is common and often represents enzyme induction and not hepatic pathology.[Ref]

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

Dermatologic

Dermatologic side effects including toxic epidermal necrolysis, pemphigus vulgaris, photosensitivity, acneiform rash, and purpura have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including a case of esophagitis have been reported.[Ref]

Hematologic

Hematologic side effects including macrocytosis and, more rarely, megaloblastic anemia have been reported.[Ref]

Endocrine

Endocrine side effects including alterations in vitamin D metabolism have been reported in patients taking phenobarbital (the active ingredient contained in Luminal) and other anticonvulsants. Hypocalcemia and osteomalacia have also been reported.[Ref]

Metabolic

Metabolic side effects including an increase in the hepatic metabolism of thyroxine (T4) and triiodothyronine (T3) have been reported.[Ref]

Oncologic

Oncologic side effects including an increased frequency of malignancy (particularly brain tumors, lung cancer, and liver cancer) have been reported. However, other investigators have not found an association with malignancy.[Ref]

Genitourinary

Genitourinary side effects including Peyronie's disease have been reported.[Ref]

References

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2. Gallassi R, Morreale A, Di Sarro R, Marra M, Lugaresi E, Baruzzi A "Cognitive effects of antiepileptic drug discontinuation." Epilepsia 33 (1992): s41-4

3. Thurston SE, Leigh RJ, Abel LA, Dell'Osso LF "Slow saccades and hypometria in anticonvulsant toxicity." Neurology 34 (1984): 1593-6

4. Sechi GP, Piras MR, Rosati G, Zuddas M, Ortu R, Tanca S, Agnetti V "Phenobarbital-induced buccolingual dyskinesia in oral apraxia." Eur Neurol 28 (1988): 139-41

5. Plaa GL "Acute toxicity of antiepileptic drugs." Epilepsia 16 (1975): 183-91

6. Smith DB "Cognitive effects of antiepileptic drugs." Adv Neurol 55 (1991): 197-212

7. Schwankhaus JD, Kattah JC, Lux WE, Masucci EF, Kurtzke JF "Primidone/phenobarbital-induced periodic alternating nystagmus." Ann Ophthalmol 21 (1989): 230-2

8. McGuire TJ, Hodges DL, Medhat MA, Redford JB "Transient locked-in syndrome and phenobarbital." Arch Phys Med Rehabil 68 (1987): 566-7

9. Iivanainen M, Savolainen H "Side effects of phenobarbital and phenytoin during long-term treatment of epilepsy." Acta Neurol Scand Suppl 97 (1983): 49-67

10. Lacayo A, Mitra N "Report of a case of phenobarbital-induced dystonia." Clin Pediatr (Phila) 31 (1992): 252

11. Sandyk R "Phenobarbital-induced Tourette-like symptoms." Pediatr Neurol 2 (1986): 54-5

12. Sylvester CE, Marchlewski A, Manaligod JM "Primidone or phenobarbital use complicating disruptive behavior disorders." Clin Pediatr (Phila) 33 (1994): 252-3

13. Mayhew LA, Hanzel TE, Ferron FR, Kalachnik JE, Harder SR "Phenobarbital exacerbation of self-injurious behavior." J Nerv Ment Dis 180 (1992): 732-3

14. Trimble MR "Anticonvulsant drugs and cognitive function: a review of the literature." Epilepsia 28 (1987): s37-45

15. Lund A, Gormsen H "The role of antiepileptics in sudden death in epilepsy." Acta Neurol Scand 72 (1985): 444-6

16. Gersema LM, Alexander B, Kunze KE "Major withdrawal symptoms after abrupt discontinuation of phenobarbital." Clin Pharm 6 (1987): 420-2

17. Theodore WH, Porter RJ, Raubertas RF "Seizures during barbiturate withdrawal: relation to blood level." Ann Neurol 22 (1987): 644-7

18. Doriguzzi C, Mongini T, Jeantet A, Monga G "Tubular aggregates in a case of osteomalacic myopathy due to anticonvulsant drugs." Clin Neuropathol 3 (1984): 42-5

19. Korst JK, van der Colenbrander H, Cats A "Phenobarbital and the shoulder-hand syndrome." Ann Rheum Dis 25 (1966): 553-5

20. Marsden CD, Reynolds EH, Parsons V, Harris R, Duchen L "Myopathy associated with anticonvulsant osteomalacia." Br Med J 4 (1973): 526-7

21. Reddy MP "Bilateral shoulder-hand syndrome associated with phenobarbital administration. A case report." Phys Ther 65 (1985): 201-2

22. Mattson RH, Cramer JA, McCutchen CB "Barbiturate-related connective tissue disorders." Arch Intern Med 149 (1989): 911-4

23. Taylor LP, Posner JB "Phenobarbital rheumatism in patients with brain tumor." Ann Neurol 25 (1989): 92-4

24. Critchley EM, Vakil SD, Hayward HW, Owen VM "Dupuytren's disease in epilepsy: result of prolonged administration of anticonvulsants." J Neurol Neurosurg Psychiatry 39 (1976): 498-503

25. Shear NH, Spielberg SP "Anticonvulsant hypersensitivity syndrome. In vitro assessment of risk." J Clin Invest 82 (1988): 1826-32

26. Mockli G, Crowley M, Stern R, Warnock ML "Massive hepatic necrosis in a child after administration of phenobarbital." Am J Gastroenterol 84 (1989): 820-2

27. Pagliaro L, Campesi G, Aguglia F "Barbiturate jaundice. Report of a case due to a barbital-containing drug, with positive rechallenge to phenobarbital." Gastroenterology 56 (1969): 938-43

28. Chen CJ, Huang YC, Wang CY, Lin TY "Fatal anticonvulsant hypersensitivity syndrome in an infant." Eur J Pediatr 162 (2003): 893-4

29. Lane T, Peterson EA "Hepatitis as a manifestation of phenobarbital hypersensitivity." South Med J 77 (1984): 94

30. Wilensky AJ "Phenytoin hypersensitivity." JAMA 237 (1977): 2600-1

31. Pelekanos J, Camfield P, Camfield C, Gordon K "Allergic rash due to antiepileptic drugs: clinical features and management." Epilepsia 32 (1991): 554-9

32. Jezequel AM, Librari ML, Mosca P, Novelli G, Lorenzini I, Orlandi F "Changes induced in human liver by long-term anticonvulsant therapy. Functional and ultrastructural data." Liver 4 (1984): 307-17

33. Ward JM, Konishi N, Ostergaard K "Hepatic lesions in Danish epileptics after long-term exposure to anticonvulsant drugs including phenobarbitone." J Natl Cancer Inst 81 (1989): 1753-4

34. Stuttgen G "Toxic epidermal necrolysis provoked by barbiturates." Br J Dermatol 88 (1973): 291-3

35. Dourmishev AL, Rahman MA "Phenobarbital-induced pemphigus vulgaris." Dermatologica 173 (1986): 256-8

36. Fernandez de Corres L, Leanizbarrutia I, Munoz D "Eczematous drug reaction from phenobarbitone." Contact Dermatitis 11 (1984): 319

37. Walsh J, Kneafsey DV "Phenobarbitone induced oesophagitis: a case report." Ir Med J 73 (1980): 399

38. Kiorboe E, Plum CM "Megaloblastic anaemia developing during treatment of epilepsy." Acta Med Scand Suppl 445 (1966): 349-57

39. Sotaniemi EA, Hakkarainen HK, Puranen JA, Lahti RO "Radiologic bone changes and hypocalcemia with anticonvulsant therapy in epilepsy." Ann Intern Med 77 (1972): 389-94

40. Zerwekh JE, Homan R, Tindall R, Pak CY "Decreased serum 24,25-dihydroxyvitamin D concentration during long- term anticonvulsant therapy in adult epileptics." Ann Neurol 12 (1982): 184-6

41. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94

42. Clemmesen J, Hjalgrim-Jensen S "Brain tumors in children exposed to barbiturates." J Natl Cancer Inst 66 (1981): 215

43. White SJ, McLean AE, Howland C "Anticonvulsant drugs and cancer. A cohort study in patients with severe epilepsy." Lancet 2 (1979): 458-61

44. Schneiderman MA "Letter: Phenobarbitone and liver tumours." Lancet 2 (1974): 1085

45. Friedman GD "Barbiturates and lung cancer in humans." J Natl Cancer Inst 67 (1981): 291-5

46. Clemmesen J "Letter: Phenobarbitone, liver tumours, and thorotrast." Lancet 1 (1975): 37-8

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