Convulzor Adverse Reactions

ER tablet: The most frequently reported adverse effects associated with valproate therapy are gastrointestinal disturbances, particularly at the start of therapy; enteric-coated formulations, taking doses with meals and starting with low doses may minimize symptoms. There may be increased appetite and weight gain in common. Less common adverse effects include oedema, headache, reversible prolongation of bleeding time, and thrombocytopenia. Leucopenia and bone marrow depression have been reported. Neurological adverse effects including ataxia, tremor, sedation, lethargy and confusion have been reported. Very rare cases of extrapyramidal symptoms or reversible dementia associated with cerebral atrophy have been reported. Increased alertness may occur, which is generally considered beneficial, but occasionally rashes and rarely hirsutism, acne, toxic epidermal necrolysis and Stevens-Johnson syndrome or erythema multiforme. Transient hair loss sometimes with regrowth of curly hair, has occurred. Irregular periods, amenorrhea and gynaecomastia have been reported rarely.
Liver dysfunction including hepatic failure has occasionally been reported, usually in the first few months of treatment, and requires valproate withdrawal; there have been fatalities. Elevation of liver enzyme values is common but normally transient and dose-related. Hyperammonemia has occurred, even in the absence of overt hepatic failure, and is sometimes associated with neurological symptoms; Hyperglycemia has been also reported. Pancreatitis has also been reported rarely, and fatalities have occurred; plasma amylase should be measured if there is acute abdominal pain, although the value of serum amylase as diagnostic tool has been questioned. In few patients there have been reports of reversible defects in renal tubular function (Fanconi's syndrome).
Congenital malformations have been reported in infants born to women who had received antiepileptics including valproate during pregnancy. Inflammatory reactions and pain have been reported at the injection site after intravenous doses.
Syrup: Epilepsy: Complex partial seizures (CPS): Divalproex sodium was generally well tolerated with most adverse events rated as mild to moderate in severity. The following additional adverse events were reported in patients complex partial seizures treated with divalproex sodium.
Body as a whole: Headache, asthenia, fever, back pain, chest pain, malaise.
Cardiovascular system: Tachycardia, hypertension, palpitation.
Digestive system: Nausea, vomiting, abdominal pain, diarrhea, anorexia, dyspepsia, constipation, increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.
Hemic and lymphatic system: Thrombocytopenia, ecchymosis, petechiae.
Metabolic and nutritional disorders: Weight gain, weight loss, peripheral edema, SGOT increased, SGPT increased.
Musculoskeletal system: Myalgia, twitching, arthralgia, leg cramps, myasthenia.
Nervous system: Somnolence, tremor, dizziness, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, thinking abnormal, amnesia, nervousness, depression, anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.
Respiratory system: Flu syndrome, infection, bronchitis, rhinitis, pharyngitis, dyspnea, sinusitis, cough increased, pneumonia, epistaxis.
Skin and appendages: Rash, pruritus, dry skin, alopecia.
Special senses: Tinnitus, taste perversion, abnormal vision, deafness, otitis media.
Urogenital system: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.
Other patient populations: Adverse events that have been reported with all dosage forms of valproate are listed as follows by body system.
Gastrointestinal: The most commonly reported side effects at the initiation of therapy are nausea, vomiting, and indigestion. These effects are usually transient and rarely require discontinuation of therapy. Diarrhea, abdominal cramps, and constipation have been reported. Both anorexia with some weight loss and increased appetite with weight gain have also been reported. The administration of delayed-release divalproex sodium may result in reduction of gastrointestinal side effects in some patients.
CNS effects: Sedative effects have occurred in patients receiving valproate alone but occur most often in patients receiving combination therapy. Sedation usually abates upon reduction of other antiepileptic medication. Tremor (may be dose-related), hallucinations, ataxia, headache, nystagmus, diplopia, asterixis, "spots before eyes", dysarthria, dizziness, confusion, hyperesthesia, vertigo, incoordination, memory impairment, cognitive disorder, and Parkinsonism have been reported with the use of valproate. Rare cases of coma have occurred in patients receiving valproate alone or in conjunction with phenobarbital. In rare instances encephalopathy with or without fever has developed shortly after the introduction of valproate monotherapy without evidence of hepatic dysfunction or inappropriately high plasma valproate levels. Although recovery has been described following drug withdrawal, there have been fatalities in patients with hyperammonemic encephalopathy, particularly in patients with underlying urea cycle disorders (see Urea cycle disorders, Hyperammonemia and encephalopathy associated with concomitant topiramate use and Hyperammonemia under Precautions).
There have been reports of reversible and irreversible cerebral and cerebellar atrophy temporally associated with the use of valproate products. In some cases the patient recovered with permanent sequelae (see Brain atrophy under Precautions). Cerebral atrophy seen in children exposed to valproate in utero led to various forms of neurological events including developmental delays and psychomotor impairment (see Use in Pregnancy and lactation).
Dermatologic: Transient hair loss, skin rash, photosensitivity, generalized pruritus, erythema multiforme, and Stevens-Johnson syndrome. Rare cases of toxic epidermal necrolysis have been reported including a fatal case in a 6 months old infant taking valproate and several other concomitant medications. An additional case of toxic epidermal necrosis resulting in death was reported in a 35 year old patient with AIDS taking several concomitant medications and with a history of multiple cutaneous drug reactions. Serious skin reactions have been reported with concomitant administration of lamotrigine and valproate (see Interactions).
Psychiatric: Emotional upset, depression, psychosis, aggression, psychomotor hyperactivity, hostility, agitation, disturbance in attention, abnormal behavior, learning disorder and behavioral deterioration.
Musculoskeletal: Weakness.
Reports have been received of decreased bone mass, potentially leading to osteoporosis and osteopenia, during long-term therapy with anticonvulsant medications, including valproate. Supplemental calcium and vitamin D may be of benefit to patients who are on chronic valproate therapy.
Hematologic: Thrombocytopenia and inhibition of the secondary phase of platelet aggregation may be reflected in altered bleeding time, petechiae, bruising, hematoma formation, epistaxis, and hemorrhage (see General under Precautions and Warfarin under Interactions). Relative lymphocytosis, macrocytosis, hypofibrinogenemia, leukopenia, eosinophilia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.
Hepatic: Minor elevations of transaminases (e.g., SGOT and SGPT) and LDH are frequent and appear to be dose-related. Occasionally, laboratory test results include increases in serum bilirubin and abnormal changes in other liver function tests. These results may reflect potentially serious hepatotoxicity (see Hepatotoxicity under Precautions).
Endocrine: Irregular menses, secondary amenorrhea, breast enlargement, galactorrhea, and parotid gland swelling. Abnormal thyroid function tests including hypothyroidism (see General under Precautions). There have been rare spontaneous reports of polycystic ovary disease. A cause and effect relationship has not been established.
Pancreatic: Acute pancreatitis, including fatalities (see Pancreatitis under Precautions).
Metabolic: Hyperammonemia (see Hyperammonemia under Precautions), hyponatremia, and inappropriate ADH secretion.
There have been rare reports of Fanconi's syndrome occurring chiefly in children.
Decreased carnitine concentrations have been reported although the clinical relevance is undetermined.
Hyperglycinemia has occurred and was associated with a fatal outcome in a patient with preexistent nonketotic hyperglycinemia.
Genitourinary: Enuresis and urinary tract infection.
Special senses: Hearing loss, either reversible or irreversible, has been reported; however, a cause and effect relationship has not been established. Ear pain has also been reported.
Neoplasma benign, malignant and unspecified (including cysts and polyps): Myelodysplastic syndrome.
Respiratory, thoracic and mediastinal disorders: Pleural effusion.
Other: Allergic reaction, anaphylaxis, edema of the extremities, lupus erythematosus, bone pain, increased cough, pneumonia, otitis media, bradycardia, cutaneous vasculitis, fever, and hypothermia.
Mania: Although valproic acid has not been evaluated for safety and efficacy in the treatment of manic episodes associated with bipolar disorder, the following adverse events not listed previoysly were reported in patients whom treated with valproic acid tablets.
Body as a whole: Chills, neck pain, neck rigidity.
Cardiovascular system: Hypotension, postural hypotension, vasodilation.
Digestive system: Fecal incontinence, gastroenteritis, glossitis.
Musculoskeletal system: Arthrosis.
Nervous system: Agitation, catatonic reaction, hypokinesia, reflexes increased, tardive dyskinesia, vertigo.
Skin and appendages: Furunculosis, maculopapular rash, seborrhea.
Special senses: Conjunctivitis, dry eyes, eye pain.
Urogenital system: Dysuria.
Migraine: Although valproic acid has not been evaluated for safety and efficacy in the treatment of prophylaxis of migraine headaches, the following adverse events not listed previously were reported in patients whom treated with valproic acid tablets.
Body as a whole: Face edema.
Digestive system: Dry mouth, stomatitis.
Urogenital system: Cystitis, metrorrhagia, and vaginal hemorrhage.