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Depakene Side Effects

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Common Depakene Side Effects


The most commonly reported Depakene side effects (click to view or check a box to report):

Convulsion (190)
Epilepsy (116)
Somnolence (74)
Confusional State (63)
Fall (60)
Vomiting (49)
Pyrexia (48)
Thrombocytopenia (46)
Asthenia (44)
Headache (41)
Dizziness (40)
Tremor (36)
Hyponatraemia (35)
Abdominal Pain (34)
Weight Increased (32)
Nausea (32)
Hyperammonaemia (32)
Suicide Attempt (32)
Petit Mal Epilepsy (31)
Alopecia (30)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Depakene Side Effects Reported to FDA



Depakene Side Effect Report#9956327
Convulsion
This is a report of a 18-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: convulsion, who was treated with Depakene (dosage: NA, start time: 201303), combined with: NA. and developed a serious reaction and side effect(s): Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in female patients, resulting in Convulsion side effect. The patient was hospitalized.
Depakene Side Effect Report#9934682
Hypothyroidism
This report suggests a potential Depakene Hypothyroidism side effect(s) that can have serious consequences. A 40-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: petit mal epilepsy,affective disorder and used Depakene (dosage: 1500 Mg Daily) starting NS. After starting Depakene the patient began experiencing various side effects, including: HypothyroidismAdditional drugs used concurrently: NA. Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypothyroidism, may still occur.
Depakene Side Effect Report#9930070
Thrombosis, Coma, Convulsion, Convulsion, Pain In Extremity
This Thrombosis problem was reported by a consumer or non-health professional from BR. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion,epilepsy,thyroid disorder. On 1984 this consumer started treatment with Depakene (dosage: One Tablet In The Morning/ One Afternoon/ One At Night). The following drugs were being taken at the same time: NA. When using Depakene, the patient experienced the following unwanted symptoms/side effects: Thrombosis, Coma, Convulsion, Convulsion, Pain In ExtremityThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Thrombosis, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9842253
Convulsion, Convulsion, Product Physical Issue
This Convulsion side effect was reported by a consumer or non-health professional from BR. A 16-year-old male patient (weight:NA) experienced the following symptoms/conditions: infantile spasms,disturbance in attention,impaired reasoning,convulsion.The patient was prescribed Depakene (drug dosage: 5 Capsules Per Day), which was initiated on 2011. Concurrently used drugs: NA..After starting to take Depakene the consumer reported adverse symptoms, such as: Convulsion, Convulsion, Product Physical IssueThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9808856
Congenital Anomaly, Intestinal Stenosis, Cardiac Valve Disease, Muscle Disorder, Foetal Anticonvulsant Syndrome, Foetal Exposure During Pregnancy, Apgar Score Low, Dysmorphism, Hypertelorism Of Orbit
This is a report of a male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: NA, who was treated with Depakene (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Congenital Anomaly, Intestinal Stenosis, Cardiac Valve Disease, Muscle Disorder, Foetal Anticonvulsant Syndrome, Foetal Exposure During Pregnancy, Apgar Score Low, Dysmorphism, Hypertelorism Of Orbit after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in male patients, resulting in Congenital Anomaly side effect. The patient was hospitalized.
Depakene Side Effect Report#9780127
Status Epilepticus
This report suggests a potential Depakene Status Epilepticus side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: lennox-gastaut syndrome and used Depakene (dosage: NA) starting
Jul 17, 2013. After starting Depakene the patient began experiencing various side effects, including: Status EpilepticusAdditional drugs used concurrently:
  • Mystan
  • Mystan
  • Keppra
  • Lamictal
  • Rufinamide
  • Rufinamide
  • Rufinamide
  • Rufinamide
Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Status Epilepticus, may still occur.
Depakene Side Effect Report#9772941
Convulsion, Incorrect Dose Administered, Convulsion, Convulsion, Parkinson^s Disease, Blood Cholesterol Increased
This Convulsion problem was reported by a consumer or non-health professional from BR. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On 2012 this consumer started treatment with Depakene (dosage: 1500 Mg; At 6:00am, At 2:00pm And At 10:00pm). The following drugs were being taken at the same time: NA. When using Depakene, the patient experienced the following unwanted symptoms/side effects: Convulsion, Incorrect Dose Administered, Convulsion, Convulsion, Parkinson^s Disease, Blood Cholesterol IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9766194
Leiomyoma, Psychotic Disorder, Anxiety, Suicidal Ideation, Off Label Use, Abdominal Pain Upper, Nausea, Polycystic Ovaries, Amenorrhoea
This Leiomyoma side effect was reported by a consumer or non-health professional from BR. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: bipolar disorder,personality disorder.The patient was prescribed Depakene (drug dosage: 1 Tablet In The Morning And 1 At Night), which was initiated on
Jan 08, 2002. Concurrently used drugs: NA..After starting to take Depakene the consumer reported adverse symptoms, such as: Leiomyoma, Psychotic Disorder, Anxiety, Suicidal Ideation, Off Label Use, Abdominal Pain Upper, Nausea, Polycystic Ovaries, AmenorrhoeaThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9732949
Convulsion, Head Injury, Tongue Injury, Therapeutic Response Decreased
This is a report of a 25-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: epilepsy, who was treated with Depakene (dosage: NA, start time:
Nov 17, 2013), combined with:
  • Hidantal
  • Hidantal
  • Hidantal
  • Hidantal
and developed a serious reaction and side effect(s): Convulsion, Head Injury, Tongue Injury, Therapeutic Response Decreased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in male patients, resulting in Convulsion side effect.
Depakene Side Effect Report#9719103
Memory Impairment, Convulsion, Petit Mal Epilepsy, Headache
This report suggests a potential Depakene Memory Impairment side effect(s) that can have serious consequences. A male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: epilepsy,convulsion and used Depakene (dosage: NA) starting NS. After starting Depakene the patient began experiencing various side effects, including: Memory Impairment, Convulsion, Petit Mal Epilepsy, HeadacheAdditional drugs used concurrently: NA. Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Memory Impairment, may still occur.
Depakene Side Effect Report#9652525
Syncope, Foreign Body, Retching, Dizziness, Headache, Eructation, Nausea
This Syncope problem was reported by a consumer or non-health professional from BR. A 17-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion prophylaxis,back pain,headache. On
Dec 26, 2012 this consumer started treatment with Depakene (dosage: 1 In Morning And 1 In Evening, But Also As Every 8 Hours). The following drugs were being taken at the same time:
  • Ibuprofen
  • Paracetamol
When using Depakene, the patient experienced the following unwanted symptoms/side effects: Syncope, Foreign Body, Retching, Dizziness, Headache, Eructation, NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9643217
Petit Mal Epilepsy, Anaemia
This Petit Mal Epilepsy side effect was reported by a consumer or non-health professional from BR. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: convulsion,vitamin supplementation,anaemia.The patient was prescribed Depakene (drug dosage: In The Morning And In The Afternoon), which was initiated on 201303. Concurrently used drugs:
  • Multivitamins W/minerals
  • Multivitamins W/minerals
.After starting to take Depakene the consumer reported adverse symptoms, such as: Petit Mal Epilepsy, AnaemiaThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9562572
Cardiac Arrest, Epilepsy, Epilepsy, Pneumonia, Dyspnoea, Movement Disorder, Epilepsy, Convulsion
This is a report of a 20-year-old female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: epilepsy, who was treated with Depakene (dosage: Morning/ Afternoon/ Night: Daily Dose 1500 Mg, start time: 201303), combined with: NA. and developed a serious reaction and side effect(s): Cardiac Arrest, Epilepsy, Epilepsy, Pneumonia, Dyspnoea, Movement Disorder, Epilepsy, Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in female patients, resulting in Cardiac Arrest side effect. The patient was hospitalized.
Depakene Side Effect Report#9536990
Convulsion, Convulsion, Convulsion, Vomiting, Malabsorption, Malaise, Product Physical Issue
This report suggests a potential Depakene Convulsion side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: post-traumatic epilepsy and used Depakene (dosage: 1 Hour After Meals) starting NS. After starting Depakene the patient began experiencing various side effects, including: Convulsion, Convulsion, Convulsion, Vomiting, Malabsorption, Malaise, Product Physical IssueAdditional drugs used concurrently:
  • Oxcarbazepine
Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Depakene Side Effect Report#9487581
Hormone Level Abnormal, Unevaluable Event, Convulsion, Incorrect Dose Administered, Dengue Fever, Menopause, Stress, Dengue Fever
This Hormone Level Abnormal problem was reported by a consumer or non-health professional from BR. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion,petit mal epilepsy,complex partial seizures,headache,arthralgia. On NS this consumer started treatment with Depakene (dosage: 1 Tablet In The Morning/ 1 At Night In Daily). The following drugs were being taken at the same time: NA. When using Depakene, the patient experienced the following unwanted symptoms/side effects: Hormone Level Abnormal, Unevaluable Event, Convulsion, Incorrect Dose Administered, Dengue Fever, Menopause, Stress, Dengue FeverAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hormone Level Abnormal, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9479232
Leiomyoma, Haemorrhage, Abdominal Pain, Abdominal Pain, Diarrhoea, Abdominal Pain, Abdominal Pain
This Leiomyoma side effect was reported by a consumer or non-health professional from BR. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Depakene (drug dosage: 1/2 Tab In Morning, 1/2 Tab At Night), which was initiated on 1993. Concurrently used drugs: NA..After starting to take Depakene the consumer reported adverse symptoms, such as: Leiomyoma, Haemorrhage, Abdominal Pain, Abdominal Pain, Diarrhoea, Abdominal Pain, Abdominal PainThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9476170
Convulsion, Product Substitution Issue
This is a report of a 10-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: epilepsy, who was treated with Depakene (dosage: Gastrostomy Tube, start time: 201204), combined with: NA. and developed a serious reaction and side effect(s): Convulsion, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in female patients, resulting in Convulsion side effect. The patient was hospitalized.
Depakene Side Effect Report#9436229
Convulsion, Product Taste Abnormal, Tic, Hyperreflexia, Blood Pressure Fluctuation, Petit Mal Epilepsy, Memory Impairment, Product Physical Issue
This report suggests a potential Depakene Convulsion side effect(s) that can have serious consequences. A male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: NA and used Depakene (dosage: 250 Mg, 1 Capsule At Night) starting 2012. After starting Depakene the patient began experiencing various side effects, including: Convulsion, Product Taste Abnormal, Tic, Hyperreflexia, Blood Pressure Fluctuation, Petit Mal Epilepsy, Memory Impairment, Product Physical IssueAdditional drugs used concurrently:
  • Hidantal (300 Milligram Per Night)
Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Depakene Side Effect Report#9433830
Haemoptysis, Intervertebral Disc Protrusion
This Haemoptysis problem was reported by a consumer or non-health professional from BR. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On 201305 this consumer started treatment with Depakene (dosage: NA). The following drugs were being taken at the same time:
  • Rivotril
  • Fluoxetine
  • Chlorpromazine
  • Acetylsalicylic Acid
  • Enalapril
  • Nifedipine
  • Captopril (50 Mg, 1 Tablet In The Morning And 1 At Night)
When using Depakene, the patient experienced the following unwanted symptoms/side effects: Haemoptysis, Intervertebral Disc ProtrusionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haemoptysis, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9423672
Epilepsy, Epilepsy, Convulsion, Somnolence, Diplopia, Product Quality Issue
This Epilepsy side effect was reported by a consumer or non-health professional from BR. A 47-year-old male patient (weight:NA) experienced the following symptoms/conditions: epilepsy.The patient was prescribed Depakene (drug dosage: 1500 Mg Daily;1 Tablet In The Morning/afternoon/night), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Depakene the consumer reported adverse symptoms, such as: Epilepsy, Epilepsy, Convulsion, Somnolence, Diplopia, Product Quality IssueThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9415767
Abasia, Depression, Paralysis, Loss Of Control Of Legs, Feeling Abnormal, Undersensing, Tongue Movement Disturbance, Weight Decreased, Malaise
This is a report of a female patient (weight: NA) from BR, suffering from the following health symptoms/conditions: NA, who was treated with Depakene (dosage: At 7pm, start time: NS), combined with:
  • Akineton (At 7pm)
  • Prolopa (1/4 Tablet Every 6 Hours)
  • Prolopa (1/4 Tablet Every 6 Hours)
  • Mantidan (At 7pm)
  • Diurisa (At 7pm)
and developed a serious reaction and side effect(s): Abasia, Depression, Paralysis, Loss Of Control Of Legs, Feeling Abnormal, Undersensing, Tongue Movement Disturbance, Weight Decreased, Malaise after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in female patients, resulting in Abasia side effect.
Depakene Side Effect Report#9397857
Fall, Haemorrhage, Somnolence
This report suggests a potential Depakene Fall side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from BR was diagnosed with the following symptoms/conditions: convulsion,cerebrovascular accident,hypertension and used Depakene (dosage: 6 Tablets Per Day, 3000 Mg) starting 2009. After starting Depakene the patient began experiencing various side effects, including: Fall, Haemorrhage, SomnolenceAdditional drugs used concurrently: NA.The patient was hospitalized. Although Depakene demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Depakene Side Effect Report#9392150
Syncope, Convulsion, Amnesia, Decreased Appetite, Weight Decreased, Drooling, Urinary Incontinence, Headache, Nervousness
This Syncope problem was reported by a consumer or non-health professional from BR. A 54-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: convulsion. On
Jul 01, 2013 this consumer started treatment with Depakene (dosage: NA). The following drugs were being taken at the same time:
  • Depakote
When using Depakene, the patient experienced the following unwanted symptoms/side effects: Syncope, Convulsion, Amnesia, Decreased Appetite, Weight Decreased, Drooling, Urinary Incontinence, Headache, NervousnessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Syncope, may become evident only after a product is in use by the general population.
Depakene Side Effect Report#9383788
Colitis Ulcerative, Pancreatitis Acute
This Colitis Ulcerative side effect was reported by a pharmacist from JP. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Depakene (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Myslee
.After starting to take Depakene the consumer reported adverse symptoms, such as: Colitis Ulcerative, Pancreatitis AcuteThese side effects may potentially be related to Depakene.
Depakene Side Effect Report#9360538
Cerebral Disorder, Coordination Abnormal, Urinary Incontinence, Hypophagia, Unresponsive To Stimuli, Hypersomnia, Lethargy
This is a report of a 58-year-old male patient (weight: NA) from BR, suffering from the following health symptoms/conditions: convulsion prophylaxis, who was treated with Depakene (dosage: NA, start time: 201306), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Disorder, Coordination Abnormal, Urinary Incontinence, Hypophagia, Unresponsive To Stimuli, Hypersomnia, Lethargy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Depakene treatment in male patients, resulting in Cerebral Disorder side effect. The patient was hospitalized.


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The appearance of Depakene on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Depakene Side Effects for Women?

Women Side EffectsReports
Convulsion 85
Epilepsy 53
Somnolence 40
Confusional State 32
Fall 29
Dizziness 28
Pyrexia 28
Vomiting 27
Thrombocytopenia 24
Nausea 23

What are common Depakene Side Effects for Men?

Men Side EffectsReports
Convulsion 105
Epilepsy 63
Somnolence 34
Confusional State 31
Fall 31
Blood Creatine Phosphokinase Increased 25
Headache 25
Asthenia 24
Thrombocytopenia 22
Pyrexia 20

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Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Depakene reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Depakene Safety Alerts, Active Ingredients, Usage Information

    NDC0074-5681
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDepakene
    NameValproic Acid
    Dosage FormCAPSULE, LIQUID FILLED
    RouteORAL
    On market since19780228
    LabelerAbbVie Inc.
    Active Ingredient(s)VALPROIC ACID
    Strength(s)250
    Unit(s)mg/1
    Pharma ClassAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mo

    Depakene Dosage, Warnings, Usage.

    Side Effects reported to FDA: 1413

    Depakene safety alerts: 2002 2000

    Reported deaths: 142

    Reported hospitalizations: 926

    Depakote / Depakene / Depacon (divalproex sodium / valproic acid / valproate sodium)

    Audience: Neuropsychiatric healthcare professionals

    FDA and Abbott strengthened the CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the label for Depakote Tablets, Depakote ER Tablets, Depakote Sprinkle Capsules, Depakene Capsules and Syrup and Depacon for Injection. Healthcare professionals were informed that hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate therapy in patients with urea cycle disorders [UCD], a group of uncommon genetic abnormalities. Patient criteria to consider in evaluation for UCD prior to initiation of valproate therapy are offered.

    [June, 2002 - Letter - Abbott]

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