Valpros Pedia Adverse Reactions

(See Statement on Usage for High Risk Groups under Precautions) Body as a whole: Very Common: Infection. Common: Fever, back pain, malaise, chills, neck pain, neck rigidity, facial edema. Rare: Myelodysplastic syndrome (may be reversible). Other Reported Effects: Hypothermia, fever with chills, sweating, cyst, accidental injury, fatigue.
Cardiovascular: Common: Chest pain, tachycardia, hypertension, palpitation, hypotension, postural hypotension, vasodilation. Other Reported Effects: Bradycardia, arrhythmia.
Gastrointestinal: Very Common: Nausea. Common: Diarrhea, vomiting, indigestion, abdominal pain, abdominal cramps, dyspepsia, constipation, flatulence, hematemesis, eructation, acute pancreatitis (may be hemorrhagic with a rapid progression from initial symptoms to death), periodontal abscess, fecal incontinence, gastroenteritis, glossitis, stomatitis, dry mouth. Uncommon: Pancreatitis (sometimes lethal), dysphagia, gum hemorrhage, mouth ulceration.
Hematologic: Common: Anemia (including macrocytic with or without folate deficiency), thrombocytopenia, hemorrhage, ecchymosis, petechiae. Uncommon: Pancytopenia, leukopenia, vasculitis. Rare: Bone marrow failure (i.e., red cell aplasia, agranulocytosis, macrocytic anemia, macrocytosis). Other Reported Effects: Red cell hypoplasia, neutropenia, reduction in blood fibrinogen and/or increase in prothrombin time, bruising, bleeding, hematoma formation, epistaxis, frank hemorrhage, relative lymphocytosis, hypofibrinogenemia, eosinophilia, aplastic anemia, acute intermittent porphyria, bone marrow suppression, inhibition of platelet aggregation resulting in prolonged bleeding time.
Hepatic: Common: Liver injury, severe liver damage (including hepatic failure), minor elevations of transaminases (i.e., alanine aminotransferase, ALT; aspartate aminotransferase, AST) and lactate dehydrogenase (LDH). Other Reported Effects: Increased serum bilirubin, abnormal changes in other liver function tests, hepatitis.
Musculoskeletal: Common: Myalgia, leg cramps, arthralgia, twitching, myasthenia, arthrosis. Uncommon: Decreased bone mass (potentially leading to osteoporosis and osteopenia), fractures. Rare: Systemic lupus erythematosus, muscular weakness, reversible skeletal muscle weakness. Other Reported Effects: Weakness, bone pain.
Metabolic/Nutritional: Common: Hyponatremia, weight gain, anorexia with some weight loss, increased appetite. Uncommon: Inappropriate antidiuretic hormone (ADH) secretion, peripheral edema, angioedema. Rare: Hyperammonemia, hypothyroidism, reversible Fanconi's syndrome, galactorrhea. Other Reported Effects: Parotid gland swelling, decreased carnitine concentrations, hyperglycemia, abnormal thyroid test results, hypoglycemia.
CNS: Very Common: Tremor. Common: Extrapyramidal disorder, stupor, somnolence, convulsion, memory impairment, headache, confusion, aggression, euphoria, agitation, disturbance in attention, asthenia, dizziness, emotional lability, thinking abnormalities, amnesia, depression, anxiety, abnormal gait, hypertonia, incoordination, abnormal dreams, personality disorder, catatonic reaction, hypokinesia, increased reflexes, tardive dyskinesia, vertigo. Uncommon: Coma, encephalopathy (with or without fever or hyperammonemia), lethargy, reversible Parkinsonism, ataxia, paresthesia. Rare: Hallucinations, excitement, increased alertness, hyperactivity, reversible dementia associated with cerebral atrophy, cognitive disorder, sedation, abnormal behavior, psychomotor hyperactivity, learning disorder, encephalopathy with or without fever. Other Reported Effects: Dysarthria, asterixis, hypesthesia, incoordination, reversible and irreversible cerebral and cerebellar atrophy, emotional upset, psychosis/acute psychosis, hostility, behavioral deterioration, insomnia, nervousness, suicidal behavior, spasmodic dysphonia.
Respiratory: Common: Flu syndrome, infection, bronchitis, rhinitis, pharyngitis, dyspnea, sinusitis, increased cough, pneumonia, epistaxis. Uncommon: Pleural effusion, hiccups.
Dermatologic and Hypersensitivity: Common: Hypersensitivity, transient alopecia (hair loss), pruritus, rash (including maculopapular), dry skin, furunculosis, seborrhea. Rare: Toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, multi-organ hypersensitivity. Very Rare: Hirsutism, acne. Other Reported Effects: Generalized pruritus, anaphylaxis, discoid lupus erythematosus, cutaneous vasculitis, photosensitivity, erythema nodosum.
Special senses: Common: Hearing loss (either reversible or irreversible), diplopia, amblyopia/blurred vision, tinnitus, taste perversion, abnormal vision, nystagmus, otitis media, conjunctivitis, dry eyes, eye pain. Other Reported Effects: Ear pain, "spots before the eyes", otic disorder, ocular disorder, photophobia.
Urogenital/Reproductive: Common: Dysmenorrhea, urinary incontinence, urinary frequency, vaginitis, dysuria, metrorrhagia, cystitis, vaginal hemorrhage. Uncommon: Secondary amenorrhea. Rare: Male infertility, polycystic ovary disease, enuresis, gynecomastia, hyperandrogenism. Other Reported Effects: Irregular menses, urinary tract infection, developmental delay, autism and/or autism spectrum disorder in the offspring of women exposed to valproate during pregnancy, interstitial nephritis.