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Depakote Sprinkle Capsules

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Depakote Sprinkle Capsules




Depakote Sprinkle Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Depakote Sprinkle Capsules (divalproex sodium) is used to treat various types of seizure disorders. It is sometimes used together with other seizure medications. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain. This medication is available in generic form. Common side effects include diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes.

Dose of Depakote Sprinkle is determined by the patient's weight, medical condition, and other factors. Depakote may interact with cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety, other seizure medications, topiramate, tolbutamide, blood thinners, aspirin, acetaminophen, zidovudine, clozapine, diazepam, meropenem, rifampin, or ethosuximide. Tell your doctor all medications you use. Depakote is not recommended for use during pregnancy. It may harm a fetus. 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. Consult your doctor about using this medication during pregnancy. 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 Depakote Sprinkle Capsules (divalproex sodium) 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.

Depakote Sprinkle Capsules 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 or pancreatitis.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), 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;
  • extreme drowsiness, lack of coordination, hallucinations;
  • 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, weight changes;
  • tremor (shaking);
  • hair loss;
  • 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 Depakote Sprinkle Capsules (Divalproex Sodium Sprinkle Capsules)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Depakote Sprinkle Capsules Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

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, notify 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 immediately if any of these serious side effects occur: signs of infection (e.g., fever, persistent sore throat).

Tell your doctor immediately if any of these unlikely but serious side effects occur: 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.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes or skin.

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).

If you notice coated particles in your stool, they are harmless. These specially coated particles do not completely dissolve and may be passed in the stool.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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 Depakote Sprinkle Capsules (Divalproex Sodium Sprinkle Capsules)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Depakote Sprinkle Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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.

In a long term (12-month) safety study in pediatric patients (n=169) between the ages of 3 and 10 years old, no clinically meaningful differences in the adverse event profile were observed when compared to adults.

Table 2 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 the placebo-controlled trial of adjunctive therapy for 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 2: Adverse Reactions Reported by ≥ 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures

Body System/Event 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 3 lists treatment-emergent adverse reactions which were reported by ≥ 5% of patients in the high dose valproate 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 valproate and other antiepilepsy drugs.

Table 3: Adverse Reactions Reported by ≥ 5% of Patients in the High Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizuresa

Body System/Event 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

a Headache was the only adverse event 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 valproate 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.

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

Photosensitivity, erythema multiforme, toxic epidermal necrolysis, 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.

Musculoskeletal

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

Hematologic

Relative lymphocytosis, macrocytosis, leukopenia, 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.

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 Depakote Sprinkle Capsules (Divalproex Sodium Sprinkle Capsules)

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Depakote Sprinkle Capsules - User Reviews

Depakote Sprinkle Capsules User Reviews

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Here is a collection of user reviews for the medication Depakote Sprinkle Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Epilepsy

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