Epitol

Carbamazepine is a prescription medication used to treat epilepsy and trigeminal neuralgia (a condition that causes facial nerve pain). Carbamazepine belongs to a group of drugs called anticonvulsants, which work by decreasing abnormal electrical activities in the brain that cause seizures. It also works by blocking nerve signals that cause pain in trigeminal neuralgia.

Carbamazepine comes in the form of an immediate-release tablet, an extended-release tablet, extended-release capsules, a chewable immediate-release tablet, and an oral suspension form. Carbamazepine may be taken 2 to 4 times daily, with or without food.

Serious side effects have been reported. See "Precautions".

The most common side effects of carbamazepine include:

• dizziness 
• drowsiness 
• problems with walking and coordination (unsteadiness) 
• nausea 
• vomiting 

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Carbamazepine can cause serious side effects, including:

1.   Rare but serious skin rashes that may lead to death. These serious skin reactions are more likely to happen when you begin taking carbamazepine within the first four months of treatment but may occur at later times. These reactions can happen in anyone, but are more likely in people of Asian descent. If you are of Asian descent, you may need a genetic blood test before you take carbamazepine to see if you are at a higher risk for serious skin reactions with this medicine. Symptoms may include: 

• skin rash
• hives
• sores in your mouth
• blistering or peeling of the skin

2. Rare but serious blood problems. Symptoms may include: 

• fever, sore throat or other infections that come and go or do not go away
• easy bruising
• red or purple spots on your body
• bleeding gums or nose bleeds
• severe fatigue or weakness

3.   Like other antiepileptic drugs, carbamazepine may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. 

Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood

Watch for early symptoms of suicidal thoughts and actions:

• Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Carbamazepine may cause other serious side effects. These include:
Irregular heartbeat - symptoms include:

• Fast, slow, or pounding heartbeat 
• Shortness of breath 
• Feeling lightheaded 
• Fainting 

Liver problems - symptoms include: 

• yellowing of your skin or the whites of your eyes 
• dark urine 
• pain on the right side of your stomach area (abdominal pain) 
• easy bruising 
• loss of appetite 
• nausea or vomiting 

Get medical help right away if you have any of the symtoms listed above.

Do not take carbamazepine if you:

• have a history of bone marrow depression. 
• are allergic to carbamazepine or any of the ingredients in carbamazepine. 
• take nefazodone. 
• are allergic to medicines called tricyclic antidepressants (TCAs). Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure. 
• have taken a medicine called a Monoamine Oxidase Inhibitor (MAOI) in the last 14 days. Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking carbamazepine until you talk to your healthcare provider. Carbamazepine taken with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how carbamazepine affects you. Carbamazepine may slow your thinking and motor skills.

Grapefruit and grapefruit juice may interact with carbamazepine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. Category D medicines have been shown to present a risk to the fetus in studies of pregnant women, but may be given to a pregnant woman the benefits to the woman outweigh the possible risks to the unborn child.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision or double vision
• continuous back-and-forth eye movements

• Actions that are out of control
• behavioral changes (especially in children)
• confusion, agitation, or hostility (especially in the elderly)
• diarrhea (severe)
• discouragement
• drooling
• fear
• feeling of unreality
• feeling sad or empty
• headache (continuing)
• increase in seizures
• irritability
• lack of appetite
• loss of balance control
• loss of interest or pleasure
• muscle trembling, jerking, or stiffness
• nausea and vomiting (severe)
• other problems with muscle control or coordination
• sense of detachment from self or body
• shakiness and unsteady walk
• shuffling walk
• stiffness of the limb
• sudden, wide mood swings
• talking, feeling, and acting with excitement
• thoughts or attempts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping
• twisting movements of the body
• uncontrolled movements, especially of the face, neck, and back
• unusual drowsiness

• Black, tarry stools
• blood in the urine or stools
• bone or joint pain
• chest pain
• cough or hoarseness
• darkening of the urine
• difficulty with speaking or slurred speech
• fainting
• frequent urination
• irregular, pounding, or unusually slow heartbeat
• lower back or side pain
• mental depression with restlessness and nervousness or other mood or mental changes
• muscle or stomach cramps
• nosebleeds or other unusual bleeding or bruising
• numbness, tingling, pain, or weakness in the hands and feet
• pain, tenderness, swelling, or bluish color in the leg or foot
• painful or difficult urination
• pale stools
• pinpoint red spots on the skin
• rapid weight gain
• rigidity
• ringing, buzzing, or other unexplained sounds in the ears
• skin rash, hives, or itching
• sore throat, chills, and fever
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, hands, feet, or lower legs
• swollen or painful glands
• sudden decrease in the amount of urine
• tightness in the chest
• trembling
• troubled breathing
• uncontrolled body movements
• unusual tiredness or weakness
• visual hallucinations (seeing things that are not there)
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness (mild)
• drowsiness (mild)
• lightheadedness
• nausea or vomiting (mild)

• Accidental injury
• aching joints or muscles
• acid or sour stomach
• back pain
• belching
• constipation
• diarrhea
• dryness of the mouth
• headache
• heartburn
• increased sensitivity of the skin to sunlight (skin rash, itching, redness or other discoloration of the skin, or severe sunburn)
• increased sweating
• indigestion
• irritation or soreness of the tongue or mouth
• lack or loss of strength
• loss of hair
• loss of memory
• problems with memory
• sexual problems in males
• sleepiness
• stomach pain, upset, or discomfort

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat seizures.
• It is used to treat pain caused by a problem with a nerve in the face.
• It may be given to you for other reasons. Talk with the doctor.

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 BOXED 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 BOXED 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.

No evidence of abuse potential has been associated with carbamazepine, nor is there evidence of psychological or physical dependence in humans.

(SEE TABLE BELOW)

Monitoring of blood levels has increased the efficacy and safety of anticonvulsants (see PRECAUTIONS, Laboratory Tests). Dosage should be adjusted to the needs of the individual patient. A low initial daily dosage with a gradual increase is advised. As soon as adequate control is achieved, the dosage may be reduced very gradually to the minimum effective level. Medication should be taken with meals.

Conversion of patients from oral Epitol® tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e., b.i.d. tablets to t.i.d. suspension).

Epilepsy

(See INDICATIONS AND USAGE)

Initial: 200 mg b.i.d. Increase at weekly intervals by adding up to 200 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily in children 12 to 15 years of age, and 1200 mg daily in patients above 15 years of age. Doses up to 1600 mg daily have been used in adults in rare instances. Maintenance: Adjust dosage to the minimum effective level, usually 800 to 1200 mg daily.

Initial: 100 mg b.i.d. Increase at weekly intervals by adding up to 100 mg/day using a t.i.d. or q.i.d. regimen until the optimal response is obtained. Dosage generally should not exceed 1000 mg daily. Maintenance: Adjust dosage to the minimum effective level, usually 400 to 800 mg daily.

Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. Increase weekly to achieve optimal clinical response administered t.i.d. or q.i.d. Maintenance: Ordinarily, optimal clinical response is achieved at daily doses below 35 mg/kg. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the therapeutic range. No recommendation regarding the safety of carbamazepine for use at doses above 35 mg/kg/24 hours can be made.

Epitol (carbamazepine tablets) may be used alone or with other anticonvulsants. When added to existing anticonvulsant therapy, the drug should be added gradually while the other anticonvulsants are maintained or gradually decreased, except phenytoin, which may have to be increased (see PRECAUTIONS, Drug Interactions, and Usage in Pregnancy, Teratogenic Effects, Pregnancy Category D).

Trigeminal Neuralgia

(See INDICATIONS AND USAGE)

Initial: On the first day, 100 mg b.i.d. for a total daily dose of 200 mg. This daily dose may be increased by up to 200 mg/day using increments of 100 mg every 12 hours only as needed to achieve freedom from pain. Do not exceed 1200 mg daily. Maintenance: Control of pain can be maintained in most patients with 400 to 800 mg daily. However, some patients may be maintained on as little as 200 mg daily, while others may require as much as 1200 mg daily. At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum effective level or even to discontinue the drug.

Applies to carbamazepine: compounding powder, intravenous solution, oral capsule extended release, oral suspension, oral tablet, oral tablet chewable, oral tablet extended release

Gastrointestinal

Very common (10% or more): Nausea (29%), vomiting (18%), constipation (10%)
Very rare (less than 0.01%): Colitis, glossitis, stomatitis, pancreatitis
Frequency not reported: Dryness of the mouth, with suppositories occasional rectal irritation may occur, diarrhea, oral ulceration
Postmarketing reports: Gastric distress, abdominal pain, anorexia[Ref]

A single case of chemical pancreatitis has been reported in association with carbamazepine intoxication.[Ref]

Endocrine

Carbamazepine increases the rate of T4 and T3 metabolism and may lead to hypothyroidism in patients with hypothyroidism who are being treated with T4. Carbamazepine may also cause a 20% to 40% decrease in serum total and free T4 concentrations and a smaller decrease in serum total and free T3 concentrations in patients who have no thyroid disease.

Chronic administration of carbamazepine (the active ingredient contained in Epitol) may increase total cholesterol and HDL cholesterol levels. Carbamazepine may also transiently increase serum triglyceride and LDL cholesterol levels. One study has suggested that demeclocycline may be useful in prophylaxis of carbamazepine-induced hyponatremia.[Ref]

Very rare (less than 0.01%): Increase in prolactin (with or without symptoms such as gynecomastia or galactorrhea), impaired male fertility and/or abnormal spermatogenesis, abnormal thyroid function tests (e.g., decreased L-thyroxine [FT4, T4, T3] and increased TSH)
Frequency not reported: Hyponatremia, pancreatitis, lower serum testosterone, lower free androgen indexes, increased cerebrospinal fluid thyrotropin-releasing hormone levels[Ref]

Hematologic

Very common (10% or more): Leucopenia
Common (1% to 10%): Eosinophilia, thrombocytopenia, neutropenia
Rare (0.01% to 0.1%): Leukocytosis, lymphadenopathy, folic acid deficiency
Very rare (less than 0.01%): Agranulocytosis, aplastic anemia, pure red cell aplasia, megaloblastic anemia, acute intermittent porphyria, reticulocytosis, hemolytic anemia
Frequency not reported: Aplastic anemia, pancytopenia, bone marrow depression, leukopenia, thrombophlebitis, thromboembolism, adenopathy[Ref]

Thrombocytopenia is the most common hematologic effect of carbamazepine and may be either mild and transient or severe. Significant decreases in white blood cell counts may occur although the values may still be within the normal range. Often counts will return to baseline during continued therapy, and therefore, discontinuation of carbamazepine may not be necessary. Dose reductions may also result in normalization of white blood cell counts. Aplastic anemia has been reported (although many of the reported cases had confounding exposures to other medications). The manufacturer reports an incidence of 2 per 1,000,000 patients for aplastic anemia and 6 per 1,000,000 patients for agranulocytosis. Cases of reticulocytosis have been reported rarely in association with carbamazepine therapy as well. In addition, cases of hemolytic anemia and erythroid arrest have been reported.

Both humoral and nonimmune mechanisms have been implicated in the etiology of carbamazepine-induced bone marrow suppression.[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Disturbances of cardiac conduction
Very rare (less than 0.01%): Bradycardia, arrhythmias, AV-block with syncope, collapse, congestive heart failure, hypertension or hypotension, aggravation of coronary artery disease, thrombophlebitis, thromboembolism[Ref]

Most of the cases of cardiovascular effects reported have occurred in patients receiving carbamazepine for trigeminal neuralgia. The reported effects included congestive heart failure, edema, hypotension, syncope and arrhythmias. In general, the doses were titrated quickly because of severe pain. Many of the doses were higher than those used to treat epilepsy. Many of the reported cardiovascular effects resolved after discontinuation of carbamazepine.

Increased sympathetic activity in the setting of seizure-induced hypoxia could predispose a patient to sudden unexpected death in epilepsy (SUDEP).[Ref]

Nervous system

Very common (10% or more): Dizziness (44%), somnolence (32%), ataxia (15%) Common (1% to 10%): Headache, tremor, vertigo
Uncommon (0.1% to 1%): Abnormal involuntary movements (tremor, asterixis, dystonia, tics)
Rare (less than 0.1%): Choreoathetotic disorders, orofacial dyskinesia, oculomotor disturbances, speech disorders (e.g., dysarthria or slurred speech), peripheral neuritis, paresthesia, paretic symptoms, neuroleptic malignant syndrome
Frequency not reported: Drowsiness, fatigue, fever and chills[Ref]

Rigidity and oculogyric crises have been reported. Euphoria has also been reported and has led to abuse of carbamazepine in some patients. Impairment of psychomotor function has been noted in association with use of the liquid suspension of carbamazepine. Additionally, impaired cognition, exacerbations of focal seizures and asterixis have been reported in association with carbamazepine treatment. One case of a lingual-facial-buccal extrapyramidal reaction has also been described.

One study has suggested that gradual withdrawal of carbamazepine over ten days results in significantly fewer generalized tonic-clonic seizures compared to rapid withdrawal over four days.

One study has suggested that the epoxide metabolite of carbamazepine may be responsible for the occasional occurrence of seizure exacerbations in patients receiving carbamazepine.[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): A delayed multi-organ hypersensitivity disorder (of serum sickness type) with fever, skin rashes, vasculitis, lymphadenopathy, disorders mimicking lymphoma, arthralgia, leucopenia, eosinophilia, hepato-splenomegaly and abnormal liver function tests, occurring in various combinations, other organs may also be affected (e.g., lungs, kidneys, pancreas, myocardium, colon)
Very rare (less than 0.01%): Aseptic meningitis (with myoclonus and peripheral eosinophilia), anaphylactic reaction, angioedema
Frequency not reported: Multiorgan hypersensitivity reactions occurring days, weeks, or months after initiating treatment[Ref]

Rash and pruritus often resolve after discontinuation of carbamazepine therapy. Both cases of lupus-like syndrome resolved after discontinuation of carbamazepine. Stevens-Johnson syndrome, erythema multiforme, and a mononucleosis-like syndrome have also been reported.[Ref]

Hepatic

Very common (10% or more): Elevated gamma-GT (due to hepatic enzyme induction) usually not clinically relevant
Common (1% to 10%): Elevated alkaline phosphatase
Uncommon (0.1% to 1%): Elevated transaminases
Rare (0.01% to 0.1%): Cholestatic and hepatocellular jaundice, hepatitis of cholestatic, parenchymal (hepatocellular), or mixed type
Very rare (less than 0.01%): Granulomatous hepatitis, hepatic failure
Frequency not reported: Liver function test abnormalities, variegate porphyria, porphyria cutanea tarda[Ref]

Alterations in liver function tests may progress to hepatotoxicity including cholangitis, granuloma formation, fever and hepatocellular necrosis. Discontinuation of carbamazepine often results in improvement in laboratory abnormalities and liver injury.[Ref]

Renal

Very rare (less than 0.01%): Interstitial nephritis, renal failure, renal dysfunction (including albuminuria, hematuria, oliguria, and elevated BUN/azotemia)[Ref]

Respiratory

Very rare (less than 0.01%): Pulmonary hypersensitivity (characterized by fever, dyspnea, pneumonitis or pneumonia), pulmonary embolism[Ref]

Dermatologic

Very common (10% or more): Allergic skin reactions, urticaria
Common (1% to 10%): Pruritus, rash, paresthesia
Uncommon (0.1% to 1%): Exfoliative dermatitis, erythroderma
Rare (0.01% to 0.1%): Systemic lupus erythematosus-like syndrome
Very rare (less than 0.01%): Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), photosensitivity, erythema multiforme, erythema nodosum, alterations in skin pigmentation, purpura, acne, sweating, alopecia, hirsutism, unusual bruising, pruritic and erythematous rashes, diaphoresis, onychomycosis, dermatitis
Frequency not reported: Psoriasiform eruption[Ref]

Dangerous, sometimes fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy are significantly more common in patients with the human leukocyte antigen (HLA) allele, HLA-B 1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including South Asian Indians. Patients with ancestry from areas in which HLA-B 1502 is present should be screened for the HLA-B 1502 allele before starting treatment with carbamazepine. If these individuals test positive, carbamazepine should not be started unless the expected benefit clearly outweighs the increased risk of serious skin reactions. Patients who have been taking carbamazepine for more than a few months without developing skin reactions are at low risk of these events ever developing from carbamazepine. This is true for patients of any ethnicity or genotype, including patients who test positive for HLA-B 1502.[Ref]

Ocular

Common (1% to 10%): Diplopia, accommodation disorders (blurred vision)
Very rare (less than 0.01%): Lens opacities, conjunctivitis
Postmarketing reports: Diplopia, oculomotor disturbances, nystagmus, photosensitivity, visual hallucinations, scattered punctate cortical lens opacities, overall impairment of the chromatic and achromatic systems, increased intraocular pressure[Ref]

Oncologic

Frequency not reported: Disorders mimicking lymphoma[Ref]

Immunologic

Frequency not reported: Antibody deficiency
Postmarketing reports: Aseptic meningitis (with myoclonus and peripheral eosinophilia)[Ref]

Psychiatric

Common (1% to 10%): Abnormal thinking
Rare (0.01% to 0.1%): Hallucinations (visual or acoustic), depression, loss of appetite, restlessness, aggressive behavior, agitation, confusion, talkativeness
Very rare (less than 0.01%): Activation of psychosis, rebound mania following discontinuation of therapy[Ref]

Genitourinary

Very rare (less than 0.01%): Sexual disturbances/impotence, abnormal spermatogenesis (with decreased sperm count and/or motility)
Frequency not reported: Urinary frequency, acute urinary retention, oliguria with elevated blood pressure, azotemia, albuminuria, glycosuria, elevated BUN, microscopic deposits in the urine[Ref]

Metabolic

Common (1% to 10%): Hyponatremia, fluid retention, edema, weight gain, reduced plasma osmolarity due to an antidiuretic hormone (ADH)-like effect (leading in rare cases to water intoxication accompanied by lethargy)
Very rare (less than 0.01%): Disturbances of bone metabolism (decrease in plasma calcium and 25-OH-cholecalciferol) leading to osteomalacia, elevated cholesterol (including HDL cholesterol), elevated triglycerides[Ref]

Musculoskeletal

Rare (0.01% to 0.1%): Muscle weakness
Very rare (less than 0.01%): Arthralgia
Postmarketing reports: Leg cramps[Ref]

Other

Very rare (less than 0.01%): Taste disturbances, tinnitus, hyperacusis, hypoacusis, changes in pitch perception[Ref]

Some side effects of Epitol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.