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Divalproex sodium affects chemicals in the body that may be involved in causing seizures.
Divalproex sodium is used to treat various types of seizure disorders. Divalproex sodium is sometimes used together with other seizure medications.
Divalproex sodium is also used to treat manic episodes related to bipolar disorder (manic depression), and to prevent migraine headaches.
Divalproex sodium may also be used for purposes not listed in this medication guide.
Divalproex sodium can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by certain genetic disorders.
You should not use divalproex sodium if you have liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease or Alpers-Huttenlocher syndrome.
Follow your doctor's instructions about taking divalproex sodium if you are pregnant. Divalproex sodium may harm an unborn baby, but having a seizure during pregnancy could harm both mother and baby. The benefit of preventing seizures may outweigh any risks to the baby.
Do not use divalproex sodium to prevent migraine headaches if you are pregnant.
Call your doctor at once if the person taking this medicine has signs of liver or pancreas problems, such as: loss of appetite, upper stomach pain (that may spread to your back), ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).
Do not stop using divalproex sodium without your doctor's advice. Stopping suddenly may cause a serious, life-threatening type of seizure.
You should not use divalproex sodium if you are allergic to it, or if you have:
liver disease;
a urea cycle disorder; or
a genetic mitochondrial (MYE-toe-KON-dree-al) disorder such as Alpers' disease or Alpers-Huttenlocher syndrome, especially in a child younger than 2 years old.
Divalproex sodium can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by a genetic mitochondrial disorder.
Tell your doctor if you have ever had:
liver problems caused by a genetic mitochondrial disorder;
depression, mental illness, or suicidal thoughts or actions;
a family history of a urea cycle disorder or infant deaths with unknown cause; or
HIV or CMV (cytomegalovirus) infection.
Some young people have thoughts about suicide when first taking divalproex sodium. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Do not use divalproex sodium to prevent migraine headaches if you are pregnant.
If you take divalproex sodium for seizures or manic episodes: This medicine can harm an unborn baby, and may affect cognitive ability (reasoning, intelligence, problem-solving) later in the child's life. However, having a seizure during pregnancy could harm both the mother and the baby. Do not start or stop taking the medicine during pregnancy without your doctor's advice.
Use effective birth control while using divalproex sodium, and tell your doctor right away if you become pregnant. Tell your doctor if you start or stop using hormonal contraception that contains estrogen (birth control pills, injections, implants, skin patches, and vaginal rings). Estrogen can interact with divalproex sodium and make it less effective in preventing seizures.
Seizure control is very important during pregnancy. The benefit of preventing seizures may outweigh any risks posed by taking divalproex sodium. There may be other seizure medications that can be more safely used during pregnancy. Follow your doctor's instructions about taking divalproex sodium while you are pregnant.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Drink plenty of water while you are taking this medication. Your dose may need to be changed if you do not get enough fluids each day.
If you cannot swallow a sprinkle capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away. Do not save it for later use.
Do not crush, chew, break, or open a delayed-release or extended-release tablet or capsule. Swallow it whole.
You may need frequent blood tests.
In case of emergency, wear or carry medical identification to let others know you use divalproex sodium.
If you need surgery, tell the surgeon ahead of time that you are using divalproex sodium.
Do not stop using divalproex sodium suddenly, even if you feel fine. Stopping suddenly may cause a serious, life-threatening type of seizure. Follow your doctor's instructions about tapering your dose.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Drinking alcohol may increase certain side effects of divalproex sodium.
Avoid driving or hazardous activity until you know how divalproex sodium will affect you. Your reactions could be impaired.
Divalproex sodium could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if the person taking this medicine has signs of liver or pancreas problems, such as: loss of appetite, upper stomach pain (that may spread to your back), ongoing nausea or vomiting, dark urine, swelling in the face, or jaundice (yellowing of the skin or eyes).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these other side effects:
confusion, tiredness, cold feeling, vomiting, change in your mental state;
easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin;
severe drowsiness;
worsening seizures; or
signs of inflammation in your body--swollen glands, flu symptoms, severe tingling or numbness, muscle weakness, chest pain, new or worsening cough with fever, trouble breathing.
Common side effects may include:
nausea, vomiting, mild stomach pain, diarrhea;
headache, mild dizziness, weakness, tremors;
problems with balance or walking;
blurred vision, double vision; or
changes in appetite, weight gain.
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.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can affect divalproex sodium. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Divalproex Sodium (www.drugs.com/mtm/divalproex-sodium.html).
Commonly reported side effects of divalproex sodium include: abdominal pain, asthenia, dizziness, drowsiness, nausea, vomiting, thrombocytopenia, and anorexia. Other side effects include: abnormality in thinking, alopecia, ataxia, nystagmus disorder, tremor, weight loss, fever, and skin rash. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to divalproex sodium: oral capsule delayed release, oral tablet delayed release, oral tablet extended release
Oral route (Tablet, Delayed Release; Capsule, Delayed Release; Tablet, Extended Release)
Hepatotoxicity (some cases fatal), usually occurring during the first 6 months of treatment, has been reported in patients receiving valproate and its derivatives. Children younger than 2 years and patients with hereditary mitochondrial disease are at a considerably increased risk of developing fatal hepatotoxicity. For these patients under 2 years, valproate sodium should be used with extreme caution as a sole agent. Use is contraindicated in patients with known mitochondrial disorders caused by mitochondrial DNA polymerase gamma (POLG) mutations and in children younger than 2 years in which mitochondrial disorder is clinically suspected. Failure of other anticonvulsants is the only indication for divalproex sodium in patients older than 2 years with hereditary mitochondrial disease. Perform POLG mutation screening as clinically indicated. Monitor patients closely and perform liver function tests prior to therapy and at frequent intervals thereafter, especially during the first 6 months. Valproate can impair cognitive development with prenatal exposure and produce major congenital malformations, particularly neural tube defects (eg, spina bifida). Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. Life-threatening pancreatitis has been reported in both children and adults receiving valproate. Cases have occurred shortly after initiation as well as several years after use. If pancreatitis is diagnosed, valproate should ordinarily be discontinued.
Along with its needed effects, divalproex sodium 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 while taking divalproex sodium:
More common
Less common
Get emergency help immediately if any of the following symptoms of overdose occur while taking divalproex sodium:
Symptoms of overdose
Some side effects of divalproex sodium 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:
More common
Less common
For Healthcare Professionals
Applies to divalproex sodium: oral delayed release capsule, oral delayed release tablet, oral tablet extended release
GeneralThe more commonly reported adverse reactions have included headache, asthenia, nausea/vomiting, abdominal pain, somnolence, tremor, dizziness, diplopia, and amblyopia/blurred vision.
GastrointestinalVery common (10% or more): Abdominal pain, diarrhea, dyspepsia, gingival disorder, nausea, vomiting
Common (1% to 10%): Constipation, dry mouth, eructation, fecal incontinence, flatulence, gastralgia, gastroenteritis, glossitis, periodontal abscess, hematemesis, stomatitis
Uncommon (0.1% to 1%): Pancreatitis (life-threatening)
HepaticCommon (1% to 10%): Increased liver enzymes (particularly early in treatment), liver injury, SGOT increased, SGPT increased
Frequency not reported: Severe liver damage (including hepatic failure sometimes resulting in death), increased serum bilirubin, abnormal changes in other liver function tests
Nervous systemVery common (10% or more): Dizziness, headache, somnolence, tremor
Common (1% to 10%): Abnormal gait, amnesia, catatonic reaction, convulsion, disturbance in attention, dysarthria, extrapyramidal disorder, hypertonia, hypokinesia, incoordination, increased reflexes, memory impairment, nystagmus, paresthesia, speech disorder, stupor, tardive dyskinesia, taste perversion
Uncommon (0.1% to 1%): Ataxia, coma, encephalopathy, lethargy, reversible Parkinsonism
Rare (less than 0.1%): Cognitive disorder, reversible dementia associated with reversible cerebral atrophy
Frequency not reported: Cerebral atrophy, dementia
Postmarketing reports: Paradoxical convulsion, parkinsonism
HematologicVery common (10% or more): Thrombocytopenia
Common (1% to 10%): Anemia, hemorrhage
Uncommon (0.1% to 1%): Leucopenia, pancytopenia
Rare (less than 0.1%): Abnormal coagulation tests (e.g., prolonged prothrombin time, prolonged activated partial thromboplastin time, prolonged thrombin time, prolonged INR), agranulocytosis, bone marrow failure, decreased coagulation factors, including pure red cell aplasia, macrocytosis
Frequency not reported: Aplastic anemia, bone marrow suppression, bruising, eosinophilia, frank hemorrhage, hypofibrinogenemia, anemia including macrocytic with or without folate deficiency, relative lymphocytosis
Postmarketing reports: Relative lymphocytosis, macrocytosis, leukopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, acute intermittent porphyria, Fanconi's syndrome (mostly children)
RespiratoryVery common (10% or more): Flu syndrome, respiratory infection
Common (1% to 10%): Bronchitis, dyspnea, epistaxis, increased cough, pharyngitis, pneumonia, rhinitis, sinusitis
Uncommon (0.1% to 1%): Pleural effusion
RenalRare (less than 0.1%): Reversible Fanconi's syndrome, tubulointerstitial nephritis
CardiovascularCommon (1% to 10%): Edema, hypertension, hypotension, palpitations, postural hypotension, peripheral edema, tachycardia, vasodilation
Frequency not reported: Bradycardia, cutaneous vasculitis, hematoma formation
Postmarketing reports: Bradycardia, cutaneous vasculitis
PsychiatricVery common (10% or more): Nervousness
Common (1% to 10%): Abnormal dreams, agitation, anxiety, aggression, confusion, depression, emotional lability, hallucinations, insomnia, personality disorder, thinking abnormalities
Rare (less than 0.1%): Abnormal behavior, learning disorder, psychomotor hyperactivity
Frequency not reported: Behavioral deterioration, hostility, psychosis
Postmarketing reports: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, behavioral deterioration
EndocrineUncommon (0.1% to 1%): Hyperandrogenism, syndrome of inappropriate ADH secretion
Rare (less than 0.1%): Hypothyroidism
Frequency not reported: Abnormal thyroid function tests, elevated serum testosterone concentrations, parotid gland swelling
Postmarketing reports: Hyperandrogenism, hirsutism, elevated testosterone level, breast enlargement, galactorrhea, parotid gland swelling, inappropriate ADH secretion, developmental delay
DermatologicVery common (10% or more): Alopecia
Common (1% to 10%): Discoid lupus erythematosus, dry skin, ecchymosis, furunculosis, maculopapular rash, petechia, pruritus, rash, seborrhea
Uncommon (0.1% to 1%): Abnormal hair texture, abnormal hair growth, hair color changes, sweating
Rare (0.01% to 0.1%): Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Very rare (less than 0.01%): Acne, hirsutism
Frequency not reported: Angioedema, generalized pruritus, photosensitivity
Postmarketing reports: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, Stevens-Johnson syndrome
GenitourinaryCommon (1% to 10%): Amenorrhea, cystitis, dysmenorrhea, dysuria, enuresis, metrorrhagia, urinary incontinence, urinary frequency, vaginal hemorrhage, vaginitis
Frequency not reported: Breast enlargement, galactorrhea, polycystic ovary disease
Postmarketing reports: Irregular menses, secondary amenorrhea, polycystic ovary disease, aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, abnormal spermatozoa morphology, enuresis, urinary tract infection
HypersensitivityFrequency not reported: Allergic reaction, anaphylaxis, hypersensitivity
MetabolicVery common (10% or more): Anorexia
Common (1% to 10%): Weight loss/gain, increased appetite, hyponatremia
Rare (less than 0.1%): Hyperammonemia
Frequency not reported: Acute intermittent porphyria, minor elevations of LDH (dose related), decreased carnitine concentrations, hyperglycinemia
Postmarketing reports: Decreased carnitine concentrations, hyponatremia, hyperglycinemia, weight gain
MusculoskeletalCommon (1% to 10%): Arthralgia, arthrosis, leg cramps, myalgia, myasthenia, twitching
Uncommon (0.1% to 1%): Decreased bone mineral density, osteopenia, osteoporosis and fractures on long term therapy
Rare (less than 0.1%): Rhabdomyolysis, systemic lupus erythematosus
Frequency not reported: Bone pain
Postmarketing reports: Fractures, decreased bone mineral density, osteopenia, osteoporosis, weakness, bone pain
OcularVery common (10% or more): Amblyopia/blurred vision, diplopia
Common (1% to 10%): Abnormal vision, conjunctivitis, diplopia, dry eyes, eye pain
OncologicRare (less than 0.1%): Myelodysplastic syndrome
OtherVery common (10% or more): Asthenia
Common (1% to 10%): Back pain, chills, deafness, ear disorder, ear pain, face edema, fever, malaise, otitis media, tinnitus, vertigo
Frequency not reported: Hypothermia, weakness
Postmarketing reports: Hearing loss
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Divalproex Sodium (www.drugs.com/mtm/divalproex-sodium.html).
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