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Stavzor

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Stavzor

Stavzor

Stavzor Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Stavzor (valproic acid) Delayed Release Capsules is used to treat various types of seizure disorders, manic episodes associated with bipolar disorder, and to prevent migraine headaches. Common side effects include drowsiness or weakness, diarrhea, constipation, upset stomach, changes in menstrual periods, enlarged breasts, tremor (shaking), hair loss, weight changes, vision changes, or unusual or unpleasant taste in your mouth.

Dosage of Stavzor depends on the condition being treated. 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 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.

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.

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.

Stavzor 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.

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) »

What is Prescribing information?

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

Stavzor FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 Event Valproate
(n=89)
Placebo
(n=97)
Nausea 22% 15%
Somnolence 19% 12%
Dizziness 12% 4%
Vomiting 12% 3%
Asthenia 10% 7%
Abdominal Pain 9% 8%
Dyspepsia 9% 8%
Rash 6% 3%
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/Event Valproate (%)
(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 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 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.

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 Placeboa

Body System Event Valproate
(n=202)
Placebo
(n=81)
Gastrointestinal System
Nausea 31% 10%
Dyspepsia 13% 9%
Diarrhea 12% 7%
Vomiting 11% 1%
Abdominal pain 9% 4%
Increased appetite 6% 4%
Nervous System
Asthenia 20% 9%
Somnolence 17% 5%
Dizziness 12% 6%
Tremor 9% 0%
Other
Weight gain 8% 2%
Back pain 8% 6%
Alopecia 7% 1%

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.

Other Patient Populations

Adverse reactions that have been reported with all dosage forms of valproate from epilepsy trials, spontaneous reports, and other sources are listed below by body system.

Gastrointestinal

The most commonly reported side effects at the initiation of therapy are nausea, vomiting, and indigestion. These effects are usually transient and rarely require discontinuation of therapy. Diarrhea, abdominal cramps, and constipation have been reported. Both anorexia with some weight loss and increased appetite with weight gain have also been reported. The administration of delayed-release valproic acid capsules may result in reduction of gastrointestinal side effects in some patients.

CNS Effects

Sedative effects have occurred in patients receiving valproate alone but occur most often in patients receiving combination therapy. Sedation usually abates upon reduction of other antiepileptic medication. Tremor (may be dose related), hallucinations, ataxia, headache, nystagmus, diplopia, asterixis, “spots before eyes,” dysarthria, dizziness, confusion, hypesthesia, vertigo, incoordination, and parkinsonism have been reported with the use of valproate. Rare cases of coma have occurred in patients receiving valproate alone or in conjunction with phenobarbital. In rare instances, encephalopathy with or without fever has developed shortly after the introduction of valproate monotherapy without evidence of hepatic dysfunction or inappropriately high plasma valproate levels. Although recovery has been described following drug withdrawal, there have been fatalities in patients with hyperammonemic encephalopathy, particularly in patients with underlying urea cycle disorders [see WARNINGS AND PRECAUTIONS].

Several reports have noted reversible cerebral atrophy and dementia in association with valproate therapy.

Dermatologic

Transient hair loss, skin rash, photosensitivity, generalized pruritus, erythema multiforme, and Stevens-Johnson syndrome. Rare cases of toxic epidermal necrolysis have been reported, including a fatal case in a 6-month-old infant taking valproate and several other concomitant medications. An additional case of toxic epidermal necrosis resulting in death was reported in a 35-year-old patient with AIDS taking several concomitant medications and with a history of multiple cutaneous drug reactions. Serious skin reactions have been reported with concomitant administration of lamotrigine and valproate [see DRUG INTERACTIONS].

Psychiatric

Emotional upset, depression, psychosis, aggression, hyperactivity, hostility, and behavioral deterioration.

Musculoskeletal

Weakness.

Hematologic

Thrombocytopenia and inhibition of the secondary phase of platelet aggregation may be reflected in altered bleeding time, petechiae, bruising, hematoma formation, epistaxis, and frank hemorrhage [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]. 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.

Hepatic

Minor elevations of transaminases (eg, SGOT and SGPT) and LDH are frequent and appear to be dose related. Occasionally, laboratory test results include increases in serum bilirubin and abnormal changes in other liver function tests. These results may reflect potentially serious hepatotoxicity [see WARNINGS AND PRECAUTIONS].

Endocrine

Irregular menses, secondary amenorrhea, breast enlargement, galactorrhea, and parotid gland swelling. Abnormal thyroid function tests [see WARNINGS AND PRECAUTIONS].

There have been rare spontaneous reports of polycystic ovary disease. A cause and effect relationship has not been established.

Pancreatic: Acute pancreatitis including fatalities [see WARNINGS AND PRECAUTIONS].

Metabolic: Hyperammonemia [see WARNINGS AND PRECAUTIONS], hyponatremia, and inappropriate ADH secretion.

There have been rare reports of Fanconi's syndrome occurring chiefly in children.

Decreased carnitine concentrations have been reported although the clinical relevance is undetermined.

Hyperglycinemia has occurred and was associated with a fatal outcome in a patient with preexistent nonketotic hyperglycinemia.

Genitourinary: Enuresis and urinary tract infection.

Special Senses: Hearing loss, either reversible or irreversible, has been reported; however, a cause and effect relationship has not been established. Ear pain has also been reported.

Other: Allergic reaction, anaphylaxis, edema of the extremities, lupus erythematosus, bone pain, cough increased, pneumonia, otitis media, bradycardia, cutaneous vasculitis, fever, and hypothermia.

There have been reports of developmental delay, autism and/or autism spectrum disorder in the offspring of women exposed to valproate during pregnancy.

Read the entire FDA prescribing information for Stavzor (Valproic Acid) »

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