Epitol Side Effects Center

Last updated on RxList: 12/9/2021
Epitol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Epitol?

Epitol (carbamazepine tablet) is an anticonvulsant and analgesic indicated to treat partial seizures with complex symptomatology (psychomotor, temporal lobe); generalized tonic-clonic seizures (grand mal); mixed seizure patterns which include the above, or other partial or generalized seizures. Epitol is also indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. Epitol is not a simple analgesic and should not be used for the relief of trivial aches or pains.

What Are Side Effects of Epitol?

Common side effects of Epitol include:

Dosage for Epitol

The initial dose of Epitol for adults and children 12 years and older is 200 mg twice daily. Increase at weekly intervals by adding up to 200 mg/day using a three or for times daily regimen until the optimal response is obtained.

What Drugs, Substances, or Supplements Interact with Epitol?

Epitol may interact with aripiprazole, tacrolimus, temsirolimus, lapatinib, nefazodone, acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids, cyclosporine, dicumarol, dihydropyridine calcium channel blockers, doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants, valproate, warfarin, ziprasidone, zonisamide, cyclophosphamide, lithium, isoniazid, other anticonvulsant medications, and some nondepolarizing neuromuscular blocking agents. Tell your doctor all medications and supplements you use.

Epitol During Pregnancy and Breastfeeding

Epitol is not recommended for use during pregnancy; it may harm a fetus. Epitol passes into breast milk and may cause adverse effects on a nursing infant. Breastfeeding while using Epitol is not recommended.

Additional Information

Our Epitol (carbamazepine tablet) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

If you have had a seizure, it means you have epilepsy. See Answer
Epitol Professional Information

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SIDE EFFECTS

If adverse reactions are of such severity that the drug must be discontinued, the physician must be aware that abrupt discontinuation of any anticonvulsant drug in a responsive epileptic patient may lead to seizures or even status epilepticus with its life-threatening hazards.

The most severe adverse reactions have been observed in the hemopoietic system and skin (see BOX WARNING), the liver, and the cardiovascular system.

The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting. To minimize the possibility of such reactions, therapy should be initiated at the lowest dosage recommended.

The following additional adverse reactions have been reported:

Hemopoietic System

Aplastic anemia, agranulocytosis, pancytopenia, bone marrow depression, thrombocytopenia, leukopenia, leukocytosis, eosinophilia, acute intermittent porphyria, variegate porphyria, porphyria cutanea tarda.

Skin

Toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see BOX WARNING), Acute Generalized Exanthematous Pustulosis (AGEP), pruritic and erythematous rashes, urticaria, photosensitivity reactions, alterations in skin pigmentation, exfoliative dermatitis, erythema multiforme and nodosum, purpura, aggravation of disseminated lupus erythematosus, alopecia, diaphoresis, onychomadesis, and hirsutism. In certain cases, discontinuation of therapy may be necessary.

Cardiovascular System

Congestive heart failure, edema, aggravation of hypertension, hypotension, syncope and collapse, aggravation of coronary artery disease, arrhythmias and AV block, thrombophlebitis, thromboembolism (e.g., pulmonary embolism), and adenopathy or lymphadenopathy. Some of these cardiovascular complications have resulted in fatalities. Myocardial infarction has been associated with other tricyclic compounds.

Liver

Abnormalities in liver function tests, cholestatic and hepatocellular jaundice, hepatitis, very rare cases of hepatic failure.

Pancreatic

Pancreatitis.

Respiratory System

Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.

Genitourinary System

Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, renal failure, and impotence. Albuminuria, glycosuria, elevated BUN, and microscopic deposits in the urine have also been reported. There have been rare reports of impaired male fertility and/or abnormal spermatogenesis.

Testicular atrophy occurred in rats receiving carbamazepine orally from 4 to 52 weeks at dosage levels of 50 to 400 mg/kg/day. Additionally, rats receiving carbamazepine in the diet for 2 years at dosage levels of 25, 75, and 250 mg/kg/day had a dose-related incidence of testicular atrophy and aspermatogenesis. In dogs, it produced a brownish discoloration, presumably a metabolite, in the urinary bladder at dosage levels of 50 mg/kg and higher. Relevance of these findings to humans is unknown.

Nervous System

Dizziness, drowsiness, disturbances of coordination, confusion, headache, fatigue, blurred vision, visual hallucinations, transient diplopia, oculomotor disturbances, nystagmus, speech disturbances, abnormal involuntary movements, peripheral neuritis and paresthesias, depression with agitation, talkativeness, tinnitus, hyperacusis, neuroleptic malignant syndrome.

There have been reports of associated paralysis and other symptoms of cerebral arterial insufficiency, but the exact relationship of these reactions to the drug has not been established.

Isolated cases of neuroleptic malignant syndrome have been reported both with and without concomitant use of psychotropic drugs.

Digestive System

Nausea, vomiting, gastric distress and abdominal pain, diarrhea, constipation, anorexia, and dryness of the mouth and pharynx, including glossitis and stomatitis.

Eyes

Scattered punctate cortical lens opacities, increased intraocular pressure (see WARNINGS, General) as well as conjunctivitis, have been reported. Although a direct causal relationship has not been established, many phenothiazines and related drugs have been shown to cause eye changes.

Musculoskeletal System

Aching joints and muscles, and leg cramps.

Metabolism

Fever and chills. Hyponatremia (see WARNINGS, General). Decreased levels of plasma calcium have been reported. Osteoporosis has been reported.

Isolated cases of a lupus erythematosus-like syndrome have been reported. There have been occasional reports of elevated levels of cholesterol, HDL cholesterol, and triglycerides in patients taking anticonvulsants.

A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications. The patient was successfully dechallenged, and the meningitis reappeared upon rechallenge with carbamazepine.

Read the entire FDA prescribing information for Epitol (Carbamazepine Tablets)

SLIDESHOW

What Is Epilepsy? Symptoms, Causes, and Treatments See Slideshow

© Epitol Patient Information is supplied by Cerner Multum, Inc. and Epitol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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