"March 4, 2010 -- One of the oldest drugs used to treat the most common form of pediatric epilepsy is also the most effective, a study shows.
As many as 17% of children with epilepsy have absence seizures, also known as petit mal seizure"...
Depakene Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Depakene (valproic acid) is an antiepileptic used to treat various types of seizure disorders. Depakene is sometimes used together with other seizure medications. Depakene is available in generic form. Common side effects of Depakene include diarrhea, constipation, upset stomach, dizziness, drowsiness, weakness, hair loss, blurred/double vision, changes in menstrual periods, enlarged breasts, ringing in the ears, shakiness (tremor), unsteadiness, weight changes, or unusual or unpleasant taste in your mouth. You may have suicidal thoughts while taking Depakene. Tell your doctor if this occurs.
For adults and children over 10 years of age, initial dose of Depakene is 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal response. Maximum optimal dose is usually below 60 mg/kg/day. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety can add to sleepiness caused by Depakene. This drug may also interact with topiramate, tolbutamide, blood thinners, aspirin or acetaminophen, zidovudine, clozapine, diazepam, meropenem or imipenem and cilastatin, rifampin, or ethosuximide. Depakene is not recommended for use during pregnancy. It may cause birth defects. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her fetus, do not stop taking this medication unless directed by your doctor. Your doctor may switch the type of medication you use during pregnancy. This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Our Depakene (valproic acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Depakene in Detail - Patient Information: Side Effects
Seek emergency medical attention if the person taking this medicine has nausea, vomiting, upper stomach pain, or loss of appetite, low fever, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). These symptoms may be early signs of liver damage. Some of these symptoms may also be early signs of pancreatitis.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these other serious side effects:
- unexplained weakness with vomiting and confusion or fainting;
- easy bruising or bleeding, blood in your urine;
- fever, chills, body aches, swollen glands, flu symptoms;
- urinating less than usual;
- hallucinations (seeing things that aren't there);
- extreme drowsiness, lack of coordination;
- double vision or back-and-forth movements of the eyes; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- mild drowsiness or weakness;
- diarrhea, constipation, upset stomach;
- changes in your menstrual periods;
- enlarged breasts;
- tremor (shaking);
- hair loss;
- weight changes;
- vision changes; or
- unusual or unpleasant taste in your mouth.
Read the entire detailed patient monograph for Depakene (Valproic Acid)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Depakene Overview - Patient Information: Side Effects
Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: signs of infection (e.g., fever, persistent sore throat, swollen lymph nodes), chest pain, easy bruising/unexplained bleeding, fast/slow/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus), feeling cold/shivering, rapid breathing, loss of consciousness.
A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor immediately if you develop unexplained weakness, vomiting, or sudden mental/mood changes (such as confusion).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Depakene (Valproic Acid)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Depakene FDA Prescribing Information: Side Effects
The following serious adverse reactions are described below and elsewhere in the labeling:
- Hepatic failure [see WARNINGS AND PRECAUTIONS]
- Birth defects [see WARNINGS AND PRECAUTIONS]
- Decreased IQ following in utero exposure [see WARNINGS AND PRECAUTIONS]
- Pancreatitis [see WARNINGS AND PRECAUTIONS]
- Hyperammonemic encephalopathy [see WARNINGS AND PRECAUTIONS]
- Suicidal behavior and ideation [see WARNINGS AND PRECAUTIONS]
- Bleeding and other hematopoietic disorders [see WARNINGS AND PRECAUTIONS]
- Hypothermia [see WARNINGS AND PRECAUTIONS]
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The data described in the following section were obtained using Depakote (divalproex sodium) tablets.
Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, Depakote was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the Depakote treated patients (6%), compared to 1% of placebo-treated patients.
Table 3 lists treatment-emergent adverse reactions which were reported by ≥ 5% of Depakotetreated patients and for which the incidence was greater than in the placebo group, in a placebo-controlled trial of adjunctive therapy for the treatment of complex partial seizures. Since patients were also treated with other antiepilepsy drugs, it is not possible, in most cases, to determine whether the following adverse reactions can be ascribed to Depakote alone, or the combination of Depakote and other antiepilepsy drugs.
Table 3: Adverse Reactions Reported by ≥ 5% of
Patients Treated with Depakote During Placebo-Controlled Trial of Adjunctive
Therapy for Complex Partial Seizures
|Body System/Reaction||Depakote (%)
(n = 77)
(n = 70)
|Body as a Whole|
Table 4 lists treatment-emergent adverse reactions which were reported by ≥ 5% of patients in the high dose Depakote group, and for which the incidence was greater than in the low dose group, in a controlled trial of Depakote monotherapy treatment of complex partial seizures. Since patients were being titrated off another antiepilepsy drug during the first portion of the trial, it is not possible, in many cases, to determine whether the following adverse reactions can be ascribed to Depakote alone, or the combination of Depakote and other antiepilepsy drugs.
Table 4: Adverse Reactions Reported by ≥ 5% of
Patients in the High Dose Group in the Controlled Trial of Depakote Monotherapy
for Complex Partial Seizures1
|Body System/Reaction||High Dose (%)
(n = 131)
|Low Dose (%)
(n = 134)
|Body as a Whole|
|Skin and Appendages|
|1 Headache was the only adverse reaction that occurred in ≥ 5% of patients in the high dose group and at an equal or greater incidence in the low dose group.|
The following additional adverse reactions were reported by greater than 1% but less than 5% of the 358 patients treated with Depakote in the controlled trials of complex partial seizures:
Body as a Whole: Back pain, chest pain, malaise.
Hemic and Lymphatic System: Petechia.
Skin and Appendages: Rash, pruritus, dry skin.
Special Senses: Taste perversion, abnormal vision, deafness, otitis media.
Although Depakene has not been evaluated for safety and efficacy in the treatment of manic episodes associated with bipolar disorder, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of Depakote tablets.
Body as a Whole: Chills, neck pain, neck rigidity.
Musculoskeletal System: Arthrosis.
Skin and Appendages: Furunculosis, maculopapular rash, seborrhea.
Special Senses: Conjunctivitis, dry eyes, eye pain.
Urogenital System: Dysuria.
Although Depakene has not been evaluated for safety and efficacy in the treatment of prophylaxis of migraine headaches, the following adverse reactions not listed above were reported by 1% or more of patients from two placebo-controlled clinical trials of Depakote tablets.
Body as a Whole: Face edema.
Digestive System: Dry mouth, stomatitis.
The following adverse reactions have been identified during post approval use of Depakote. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Neurologic: There have been several reports of acute or subacute cognitive decline and behavioral changes (apathy or irritability) with cerebral pseudoatrophy on imaging associated with valproate therapy; both the cognitive/behavioral changes and cerebral pseudoatrophy reversed partially or fully after valproate discontinuation.
Hematologic: Relative lymphocytosis, macrocytosis, leucopenia, anemia including macrocytic with or without folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, and acute intermittent porphyria.
Endocrine: Irregular menses, secondary amenorrhea, breast enlargement, galactorrhea, parotid gland swelling, polycystic ovary disease, decreased carnitine concentrations, hyponatremia, hyperglycinemia, and inappropriate ADH secretion.
There have been rare reports of Fanconi's syndrome occurring chiefly in children.
Special Senses: Hearing loss.
Read the entire FDA prescribing information for Depakene (Valproic Acid)
Additional Depakene Information
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Report Problems to the Food and Drug Administration
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