Stavzor

Last updated on RxList: 1/21/2020
Stavzor Side Effects Center

Last reviewed on RxList 1/21/2020

What Is Stavzor?

Stavzor (valproic acid) Delayed Release Capsules is an anticonvulsant used to treat various types of seizure disorders, manic episodes associated with bipolar disorder, and to prevent migraine headaches.

What Are Side Effects of Stavzor?

Common side effects of Stavzor include: < br/>

  • drowsiness
  • weakness
  • diarrhea
  • constipation
  • upset stomach
  • abdominal pain
  • nausea
  • vomiting
  • indigestion
  • changes in menstrual periods
  • enlarged breasts
  • tremor (shaking)
  • dizziness
  • hair loss
  • weight changes
  • rash
  • vision changes, or
  • unusual or unpleasant taste in your mouth

Dosage for Stavzor

Dosage of Stavzor depends on the condition being treated.

What Drugs, Substances, or Supplements Interact with Stavzor?

Stavzor may interact with topiramate, tolbutamide, blood thinners, aspirin or acetaminophen (Tylenol), zidovudine, clozapine, diazepam, meropenem or imipenem and cilastatin, rifampin, ethosuximide, cold or allergy medicine, narcotics, sleeping pills, muscle relaxers, and medicine for depression or anxiety. Tell your doctor all medications and supplements you use.

Stavzor During Pregnancy and Breastfeeding

Stavzor can cause birth defects. Do not start taking Stavzor without telling your doctor if you are pregnant or planning to become pregnant. Use birth control while taking Stavzor. Having a seizure during pregnancy could harm both mother and baby. If you become pregnant while taking Stavzor, do not stop taking the medicine without your doctor's advice. This drug passes into breast milk and may harm a nursing baby. Do not breastfeed while taking Stavzor.

Additional Information

Our Stavzor (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.

SLIDESHOW

What Is Bipolar Disorder? Symptoms, Manic Episodes, Testing See Slideshow
Stavzor Consumer Information

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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).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

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; or
  • worsening seizures.

Severe drowsiness may be more likely in older adults.

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea;
  • dizziness, drowsiness, weakness;
  • headache;
  • tremors, problems with walking or coordination;
  • blurred vision, double vision;
  • hair loss; 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.

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

QUESTION

Another term that has been previously used for bipolar disorder is ___________________. See Answer
Stavzor Professional 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]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
  • Somnolence in the elderly [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.

Mania

The incidence of adverse reactions has been ascertained based on combined data from 2 placebo-controlled clinical trials of valproate in the treatment of manic episodes associated with bipolar disorder. The adverse reactions were usually mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In clinical trials, the rates of premature termination due to intolerance were not statistically different between placebo, valproate, and lithium carbonate. A total of 4%, 8% and 11% of patients discontinued therapy due to intolerance in the placebo, valproate, and lithium carbonate groups, respectively.

Table 2 summarizes those adverse reactions reported for patients in these trials where the incidence rate in the valproate-treated group was greater than 5% and greater than the placebo incidence, or where the incidence in the valproate-treated group was statistically significantly greater than the placebo group. Vomiting was the only event that was reported by significantly (p ≤ 0.05) more patients receiving valproate compared to placebo.

Table 2. Adverse Reactions Reported by >5% of Valproate-Treated Patients During Placebo-Controlled Trials of Acute Maniaa

Adverse ReactionValproate
(n=89)
%
Placebo
(n=97)
%
Nausea2215
Somnolence1912
Dizziness124
Vomiting123
Accidental Injury115
Asthenia107
Abdominal Pain98
Dyspepsia98
Rash63
a. The following adverse reactions occurred at an equal or greater incidence for placebo than for valproate: back pain, headache, constipation, diarrhea, tremor, and pharyngitis.

The following additional adverse reactions were reported by greater than 1% but not more than 5% of the 89 valproate-treated patients in controlled clinical trials:

Body as a Whole: Chest pain, chills, chills and fever, fever, neck pain, neck rigidity.

Cardiovascular System: Hypertension, hypotension, palpitations, postural hypotension, tachycardia, vasodilation.

Digestive System: Anorexia, fecal incontinence, flatulence, gastroenteritis, glossitis, periodontal abscess.

Hemic and Lymphatic System: Ecchymosis.

Metabolic and Nutritional Disorders: Edema, peripheral edema.

Musculoskeletal System: Arthralgia, arthrosis, leg cramps, twitching.

Nervous System: Abnormal dreams, abnormal gait, agitation, ataxia, catatonic reaction, confusion, depression, diplopia, dysarthria, hallucinations, hypertonia, hypokinesia, insomnia, paresthesia, reflexes increased, tardive dyskinesia, thinking abnormalities, vertigo.

Respiratory System: Dyspnea, rhinitis.

Skin and Appendages: Alopecia, discoid lupus erythematosus, dry skin, furunculosis, maculopapular rash, seborrhea.

Special Senses: Amblyopia, conjunctivitis, deafness, dry eyes, ear pain, eye pain, tinnitus.

Urogenital System: Dysmenorrhea, dysuria, urinary incontinence.

Epilepsy

Based on a placebo-controlled trial of adjunctive therapy for treatment of complex partial seizures, valproate was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Intolerance was the primary reason for discontinuation in the valproate-treated patients (6%), compared to 1% of placebo-treated patients.

Table 3 lists treatment-emergent adverse reactions which were reported by ≥ 5% of valproate-treated 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 valproate alone, or the combination of valproate and other antiepilepsy drugs.

Table 3. Adverse Reactions Reported by ≥ 5% of Patients Treated with Valproate During Placebo-Controlled Trial of Adjunctive Therapy for Complex Partial Seizures

Body System/EventValproate
(n = 77)
%
Placebo
(n = 70)
%
Body as a Whole
Headache3121
Asthenia277
Fever64
Gastrointestinal System
Nausea4814
Vomiting277
Abdominal pain236
Diarrhea136
Anorexia120
Dyspepsia84
Constipation51
Nervous System
Somnolence2711
Tremor256
Dizziness2513
Diplopia169
Amblyopia/Blurred Vision129
Ataxia81
Nystagmus81
Emotional Lability64
Thinking Abnormal60
Amnesia51
Respiratory System
Flu Syndrome129
Infection126
Bronchitis51
Rhinitis54
Other
Alopecia61
Weight Loss60

Table 4 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 valproate 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 valproate alone, or the combination of valproate and other antiepilepsy drugs.

Table 4. Adverse Reactions Reported by ≥5% of Patients in the High-Dose Group in the Controlled Trial of Valproate Monotherapy for Complex Partial Seizuresasa

Body System/EventHigh Dose
(n = 131)
%
Low Dose
(n = 134)
%
Body as a Whole
Asthenia2110
Digestive System
Nausea3426
Diarrhea2319
Vomiting2315
Abdominal pain129
Anorexia114
Dyspepsia1110
Hemic/Lymphatic System
Thrombocytopenia241
Ecchymosis54
Metabolic/Nutritional
Weight Gain94
Peripheral Edema83
Nervous System
Tremor5719
Somnolence3018
Dizziness1813
Insomnia159
Nervousness117
Amnesia74
Nystagmus71
Depression54
Respiratory System
Infection2013
Pharyngitis82
Dyspnea51
Skin and Appendages
Alopecia2413
Special Senses
Amblyopia/Blurred Vision84
Tinnitus71
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.

Migraine

Based on 2 placebo-controlled clinical trials and their long-term extension, valproate was generally well tolerated with most adverse reactions rated as mild to moderate in severity. Of the 202 patients exposed to valproate in the placebo-controlled trials, 17% discontinued for intolerance. This is compared to a rate of 5% for the 81 placebo patients. Including the long-term extension study, the adverse reactions reported as the primary reason for discontinuation by ≥1% of 248 valproate-treated patients were alopecia (6%), nausea and/or vomiting (5%), weight gain (2%), tremor (2%), somnolence (1%), elevated SGOT and/or SGPT (1%), and depression (1%).

Table 5 includes those adverse reactions reported for patients in the placebo-controlled trials where the incidence rate in the valproate-treated group was greater than 5% and was greater than that for placebo patients.

Table 5. Adverse Reactions Reported by >5% of Valproate-Treated Patients During Migraine Placebo-Controlled Trials with a Greater Incidence Than Patients Taking

Body System EventValproate
(n = 202)
%
Placebo
(n = 81)
%
Gastrointestinal System
Nausea3110
Dyspepsia139
Diarrhea127
Vomiting111
Abdominal pain94
Increased appetite64
Nervous System
Asthenia209
Somnolence175
Dizziness126
Tremor90
Other
Weight gain82
Back pain86
Alopecia71

The following additional adverse reactions were reported by greater than 1% but not more than 5% of the 202 valproate-treated patients in the controlled clinical trials:

Body as a Whole: Chest pain, chills, face edema, fever and malaise.

Cardiovascular System: Vasodilatation.

Digestive System: Anorexia, constipation, dry mouth, flatulence, gastrointestinal disorder (unspecified), and stomatitis.

Hemic and Lymphatic System: Ecchymosis.

Metabolic and Nutritional Disorders: Peripheral edema, SGOT increase, and SGPT increase.

Musculoskeletal System: Leg cramps and myalgia.

Nervous System: Abnormal dreams, amnesia, confusion, depression, emotional lability, insomnia, nervousness, paresthesia, speech disorder, thinking abnormalities, and vertigo.

Respiratory System: Cough increased, dyspnea, rhinitis, and sinusitis.

Skin and Appendages: Pruritus and rash.

Special Senses: Conjunctivitis, ear disorder, taste perversion, and tinnitus.

Urogenital System: Cystitis, metrorrhagia, and vaginal hemorrhage.

Post Marketing Experience

The following adverse reactions have been identified during post approval use of STAVZOR (valproic acid) or divalproex sodium. 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: Paradoxical convulsion, parkinsonism

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, hypofibrinogenemia, leukopenia, eosinophilia, 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, polycystic ovary disease, parotid gland swelling, 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 Stavzor (Valproic Acid)

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

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