Valpros/Valpros i-IV Adverse Reactions

Valpros: Neoplasms Benign, Malignant and Unspecified (including cysts and polyps): Myelodysplastic syndrome.
Blood and Lymphatic System Disorders: Thrombocytopenia, anemia, aplastic anemia, leukopenia, pancytopenia with or without bone marrow depression, decreased blood fibrinogen, red cell hypoplasia, neutropenia; bone marrow failure, including pure red cell aplasia, agranulocytosis; anemia including macrocytic with or without folate deficiency, anemia macrocytosis, ecchymosis, petechia, lymphocytosis, bone marrow suppression, acute intermittent porphyria.
Immune System Disorders: Angioedema, anaphylaxis, allergic reaction, cutaneous vasculitis.
Endocrine Disorders: Hypothyroidism, hyperandrogenism (e.g., hirsutism, virilism, androgen increased), parotid gland swelling, hyperglycemia.
Gastrointestinal Disorders: Nausea, upper abdominal pain, diarrhea, gingival disorder (mainly gingival hyperplasia), stomatitis, vomiting, abdominal cramp, upper abdominal pain, anorexia, increased appetite, pancreatitis, constipation, gastralgia, dyspepsia, flatulence, hematemesis, eructation, periodontal abscess, taste perversion, fetal incontinence, gastroenteritis, glossitis, dry mouth.
Hepatobiliary Disorders: Hepatic dysfunction, including hepatic failure; liver injury, AST and ALT increased.
Metabolism and Nutrition Disorders: Hyperammonemia, asymptomatic elevations of ammonia, hyponatremia, syndrome of inappropriate secretion of ADH (SIADH).
Psychiatric Disorders: Depression, excitement, hyperactivity, behavioral disorders, confusional state, hallucinations, aggression, agitation, disturbance in attention, abnormal behavior, psychomotor hyperactivity, learning disorder, emotional lability, thinking abnormal, anxiety, abnormal gait, personality disorder, emotional upset, psychosis, hostility, behavioral deterioration, developmental delay.
Nervous System Disorders: Drowsiness, sedation, tremor, stupor, somnolence, convulsion, memory impairment, headache, nystagmus, dizziness, ataxia, coma, encephalopathy, lethargy, paresthesia, reversible dementia associated with reversible cerebral atrophy and cognitive disorder; reversible parkinsonism, extrapyramidal disorder which may not be reversible; twitching, hypertonia, incoordination, abnormal dreams, catatonic reaction, hypokinesia, reflexes increased, tardive dyskinesia, vertigo.
Eye Disorders: Diplopia, amblyopia/blurred vision, abnormal vision, conjunctivitis, dry eyes, eye pain.
Ear and Labyrinth Disorders: Deafness, either reversible or irreversible, tinnitus, otitis media, hearing loss.
Cardiac Disorders: Chest pain, tachycardia, hypertension, palpitation, hypotension, postural hypotension, bradycardia.
Vascular Disorders: Hemorrhage, vasculitis, vasodilation.
Respiratory, Thoracic and Mediastinal Disorders: Pleural effusion, flu syndrome, bronchitis, rhinitis, pharyngitis, dyspnea, sinusitis, cough increased, pneumonia, epistaxis.
Skin and Subcutaneous Tissue Disorders: Hypersensitivity, transient and/or dose-related alopecia, hirsutism, acne, pruritus, urticaria, Stevens-Johnson Syndrome, angioedema, rash, hair disorder (e.g., hair texture abnormal, hair color changes, hair growth abnormal), toxic epidermal necrolysis, erythema multiforme, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) syndrome, dry skin, furunculosis, maculopapular rash, seborrhea, photosensitivity.
Musculoskeletal and Connective Tissue Disorders: Decreased bone mineral density, osteopenia, osteoporosis, and fractures, systemic lupus erythematosus, rhabdomyolysis, back pain, neck pain, neck rigidity, myalgia, twitching, arthralgia, leg cramps, myasthenia, arthrosis, bone pain.
Renal and Urinary Disorders: Enuresis, tubulointerstitial nephritis, Fanconi's syndrome, urinary incontinence, urinary frequency, dysuria, cystitis, enuresis, urinary tract infection.
Reproductive System and Breast Disorders: Irregular menses, amenorrhea, breast enlargement, galactorrhea, dysmenorrhea, male infertility, polycystic ovaries, vaginitis, metrorrhagia, vaginal hemorrhage.
Investigations: Coagulation factors decreased, abnormal coagulation tests (such as prolonged prothrombin time, activated partial thromboplastin time, thrombin time and INR) and biotin deficiency/biotinidase deficiency; decreased carnitine concentrations.
General Disorders and Administration Site Conditions: Edema, peripheral edema, face edema, hypothermia, increased weight, weight loss, pain, asthenia, fever, fatigue, malaise, chills, weakness.
Valpros i-IV: Body as a Whole: Pain (unspecified), peripheral edema.
Cardiovascular: Chest pain, vasodilation, vasculitis.
Endocrine/Metabolic/Nutritional: Weight gain, hyperammonemia, hyponatremia.
Nervous/Psychiatric: Headache, dizziness, nervousness, sedation, ataxia, paresthesia, hypesthesia, extrapyramidal symptoms including parkinsonism, tremor, reversible dementia, somnolence, hallucination, convulsion, encephalopathy, coma, euphoria, lethargy, confusion, abnormal gait, aggression, alertness increased, hyperactivity, behavioral deterioration.
Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting, pancreatitis, gastralgia.
Hematologic: Thrombocytopenia; anemia; leukopenia; pancytopenia; bone marrow failure, including red cell aplasia; agranulocytosis; blood fibrinogen reduced; increased prothrombin time.
Hepatic: Hepatic dysfunction; severe liver damage, including hepatic failure; increased liver enzymes.
Respiratory: Pharyngitis, pneumonia.
Skin and appendages: Injection site inflammation, injection site pain, injection site reaction, sweating, transient hair loss, hirsutism, acne, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, angioedema, drug rash with eosinophilia systemic symptoms (DRESS) syndrome, allergic reactions.
Special senses: Hearing loss, taste perversion.
Urogenital/Reproductive: Fanconi's syndrome, amenorrhea, irregular periods, gynecomastia.
Adverse events that have been reported with all dosage forms of valproate: Body as a Whole: Asthenia, fever, hypothermia, chills, infection, malaise, fatigue, edema of the extremities, face edema.
Cardiovascular: Tachycardia, bradycardia, hypertension, hypotension, postural hypotension, vasodilation, palpitation.
Endocrine/Metabolic/Nutritional: Anorexia, weight loss, increased appetite, syndrome of inappropriate secretion of ADH (SIADH), parotid gland swelling, abnormal thyroid function tests, decreased carnitine concentrations, hyperglycinemia.
Nervous/Psychiatric: Drowsiness, hypertonia, incoordination, catatonic reaction, hypokinesia, reflexes increased, tardive dyskinesia, asterixis, insomnia, abnormal dreams, amnesia, dementia, dysarthria, vertigo, cerebral atrophy, emotional lability, thinking abnormal, emotional upset, depression, anxiety, stupor, personality disorder, excitement, psychosis, hostility, agitation.
Gastrointestinal: Periodontal abscess, dry mouth, glossitis, stomatitis, abdominal cramps, dyspepsia, indigestion, constipation, gastroenteritis, flatulence, hematemesis, eructation, fecal incontinence.
Hematologic: Ecchymosis, petechia, neutropenia, altered bleeding time, bruising, hematoma formation, epistaxis, hemorrhage, lymphocytosis, macrocytosis, hypofibrinogenemia, eosinophilia, anemia including macrocytic anemia with or without folate deficiency, aplastic anemia, acute intermittent porphyria, bone marrow suppression, lupus erythematosus.
Hepatic: Serum bilirubin increased.
Musculoskeletal: Back pain, neck pain, neck rigidity, myalgia, twitching, arthralgia, arthrosis, leg cramps, myasthenia, weakness, bone pain.
Respiratory: Flu syndrome, bronchitis, rhinitis, dyspnea, sinusitis, cough increased.
Skin and appendages: Alopecia, rash, pruritus, dry skin, photosensitivity, furunculosis, maculopapular rash, seborrhea.
Special senses: Diplopia, amblyopia/blurred vision, abnormal vision, spots before eyes, conjunctivitis, dry eyes, eye pain, nystagmus, deafness, otitis media, tinnitus.
Urogenital/Reproductive: Urinary incontinence, urinary frequency, enuresis, dysuria, cystitis, vaginitis, vaginal hemorrhage, dysmenorrhea, metrorrhagia, galactorrhea.