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Depakene

Last reviewed on RxList: 3/17/2017
Depakene Side Effects Center

Last reviewed on RxList 10/28/2016

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 or other vision changes,
  • changes in menstrual periods,
  • enlarged breasts,
  • ringing in the ears,
  • shakiness (tremor),
  • unsteadiness,
  • weight changes, or
  • unusual or unpleasant taste in your mouth.

Some patients have suicidal thoughts while taking Depakene. Tell your doctor if this occurs. Tell your doctor if you have serious side effects of Depakene including:

  • signs of infection (e.g., fever, persistent sore throat, swollen lymph nodes),
  • chest pain,
  • easy bruising or unexplained bleeding,
  • fast/slow/irregular heartbeat,
  • swelling of hands or feet,
  • uncontrolled eye movement (nystagmus),
  • feeling cold/shivering,
  • rapid breathing, or
  • loss of consciousness.

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 breastfeeding.

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.

Depakene Consumer Information

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.

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.

Read the entire detailed patient monograph for Depakene (Valproic Acid)

Depakene Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in the labeling:

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.

Epilepsy

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 Depakotetreated 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)
Placebo (%)
(n = 70)
Body as a Whole
  Headache 31 21
  Asthenia 27 7
  Fever 6 4
Gastrointestinal System
  Nausea 48 14
  Vomiting 27 7
  Abdominal Pain 23 6
  Diarrhea 13 6
  Anorexia 12 0
  Dyspepsia 8 4
  Constipation 5 1
Nervous System
  Somnolence 27 11
  Tremor 25 6
  Dizziness 25 13
  Diplopia 16 9
  Amblyopia/Blurred Vision 12 9
  Ataxia 8 1
  Nystagmus 8 1
  Emotional Lability 6 4
  Thinking Abnormal 6 0
  Amnesia 5 1
Respiratory System
  Flu Syndrome 12 9
  Infection 12 6
  Bronchitis 5 1
  Rhinitis 5 4
Other
  Alopecia 6 1
  Weight Loss 6 0

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
  Asthenia 21 10
Digestive System
  Nausea 34 26
  Diarrhea 23 19
  Vomiting 23 15
  Abdominal Pain 12 9
  Anorexia 11 4
  Dyspepsia 11 10
Hemic/Lymphatic System
  Thrombocytopenia 24 1
  Ecchymosis 5 4
Metabolic/Nutritional
  Weight Gain 9 4
  Peripheral Edema 8 3
Nervous System
  Tremor 57 19
  Somnolence 30 18
  Dizziness 18 13
  Insomnia 15 9
  Nervousness 11 7
  Amnesia 7 4
  Nystagmus 7 1
  Depression 5 4
Respiratory System
  Infection 20 13
  Pharyngitis 8 2
  Dyspnea 5 1
Skin and Appendages
  Alopecia 24 13
Special Senses
  Amblyopia/Blurred Vision 8 4
  Tinnitus 7 1
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.

Cardiovascular System: Tachycardia, hypertension, palpitation.

Digestive System: Increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess.

Hemic and Lymphatic System: Petechia.

Metabolic and Nutritional Disorders: SGOT increased, SGPT increased.

Musculoskeletal System: Myalgia, twitching, arthralgia, leg cramps, myasthenia.

Nervous System: Anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder.

Respiratory System: Sinusitis, cough increased, pneumonia, epistaxis.

Skin and Appendages: Rash, pruritus, dry skin.

Special Senses: Taste perversion, abnormal vision, deafness, otitis media.

Urogenital System: Urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.

Mania

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.

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 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.

Urogenital System: Cystitis, metrorrhagia, and vaginal hemorrhage.

Post-Marketing Experience

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.

Dermatologic: Hair texture changes, hair color changes, photosensitivity, erythema multiforme, toxic epidermal necrolysis, nail and nail bed disorders, and Stevens-Johnson syndrome.

Psychiatric: Emotional upset, psychosis, aggression, psychomotor hyperactivity, hostility, disturbance in attention, learning disorder, and behavioral deterioration.

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.

There have been reports of acute or subacute encephalopathy in the absence of elevated ammonia levels, elevated valproate levels, or neuroimaging changes. The encephalopathy reversed partially or fully after valproate discontinuation.

Musculoskeletal: Fractures, decreased bone mineral density, osteopenia, osteoporosis, and weakness.

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, hyperandrogenism, hirsutism, elevated testosterone level, 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.

Metabolism and nutrition: Weight gain.

Reproductive: Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology.

Genitourinary: Enuresis and urinary tract infection.

Special Senses: Hearing loss.

Other: Allergic reaction, anaphylaxis, developmental delay, bone pain, bradycardia, and cutaneous vasculitis.

Read the entire FDA prescribing information for Depakene (Valproic Acid)

Related Resources for Depakene

Read the Depakene User Reviews »

© Depakene Patient Information is supplied by Cerner Multum, Inc. and Depakene Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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