Stavzor Side Effects

Generic Name: valproic acid

Note: This document contains side effect information about valproic acid. Some of the dosage forms listed on this page may not apply to the brand name Stavzor.

Some side effects of Stavzor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to valproic acid: oral capsule delayed release, oral capsule liquid filled, oral syrup, oral tablet delayed release, oral tablet enteric coated, oral tablet extended release

Other dosage forms:

Along with its needed effects, valproic acid (the active ingredient contained in Stavzor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking valproic acid:

More common
  • Black, tarry stools
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • confusion
  • cough or hoarseness
  • crying
  • delusions
  • dementia
  • depersonalization
  • diarrhea
  • difficult or labored breathing
  • dysphoria
  • euphoria
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • lower back or side pain
  • mental depression
  • muscle aches and pains
  • nausea
  • nervousness
  • painful or difficult urination
  • paranoia
  • pinpoint red spots on the skin
  • quick to react or overreact emotionally
  • rapid weight gain
  • rapidly changing moods
  • runny nose
  • shakiness in the legs, arms, hands, or feet
  • shivering
  • sleepiness or unusual drowsiness
  • sore throat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trembling or shaking of the hands or feet
  • trouble with sleeping
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
Less common
  • Abnormal dreams
  • absence of or decrease in body movement
  • anxiety
  • bloody nose
  • bloody or cloudy urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in personality
  • change in walking and balance
  • changes in patterns and rhythms of speech
  • chest pain
  • chills
  • clumsiness or unsteadiness
  • cold sweats
  • constipation
  • darkened urine
  • degenerative disease of the joint
  • difficult, burning, or painful urination
  • difficulty with moving
  • discouragement
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • dry mouth
  • excessive muscle tone
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fear
  • feeling of warmth or heat
  • feeling sad or empty
  • flushing or redness of the skin, especially on the face and neck
  • frequent urge to urinate
  • heavy non-menstrual vaginal bleeding
  • hyperventilation
  • increased need to urinate
  • indigestion
  • irritability
  • lack of appetite
  • lack of coordination
  • large, flat, blue, or purplish patches in the skin
  • leg cramps
  • lip smacking or puckering
  • loss of bladder control
  • loss of interest or pleasure
  • loss of strength or energy
  • multiple swollen and inflamed skin lesions
  • muscle pain or stiffness
  • muscle tension or tightness
  • normal menstrual bleeding occurring earlier, possibly lasting longer than expected
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • passing urine more often
  • pounding in the ears
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • rapid weight gain
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • shakiness and unsteady walk
  • slurred speech
  • small red or purple spots on the skin
  • sweating
  • swollen joints
  • tiredness
  • trouble with concentrating
  • trouble with speaking
  • twitching
  • uncontrolled chewing movements
  • uncontrolled movements of the arms and legs
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • vomiting of blood or material that looks like coffee grounds
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking valproic acid:

Symptoms of overdose
  • Change in consciousness
  • fainting
  • loss of consciousness
  • slow or irregular heartbeat

Some side effects of valproic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • body aches or pain
  • change in vision
  • congestion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • hair loss or thinning of the hair
  • hearing loss
  • heartburn
  • impaired vision
  • lack or loss of strength
  • loss of memory
  • problems with memory
  • rash
  • seeing double
  • sleeplessness
  • tender, swollen glands in the neck
  • trouble with swallowing
  • unable to sleep
  • uncontrolled eye movements
  • voice changes
  • weight gain
  • weight loss
Less common
  • Absent, missed, or irregular menstrual periods
  • back pain
  • burning, dry, or itching eyes
  • change in taste or bad unusual or unpleasant (after) taste
  • coin-shaped lesions on the skin
  • cough producing mucus
  • cramps
  • dandruff
  • discharge or excessive tearing
  • dry skin
  • earache
  • excess air or gas in the stomach or intestines
  • eye pain
  • feeling of constant movement of self or surroundings
  • full feeling
  • heavy bleeding
  • increased appetite
  • itching of the vagina or genital area
  • itching skin
  • loss of bowel control
  • neck pain
  • oily skin
  • pain
  • pain during sexual intercourse
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • rash with flat lesions or small raised lesions on the skin
  • redness or swelling in the ear
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • redness, swelling, or soreness of the tongue
  • sensation of spinning
  • sneezing
  • stiff neck
  • stopping of menstrual bleeding
  • thick, white vaginal discharge with no odor or with a mild odor

For Healthcare Professionals

Applies to valproic acid: injectable solution, intravenous solution, oral capsule, oral delayed release capsule, oral syrup

Gastrointestinal

Gastrointestinal side effects have been reported frequently and include nausea, vomiting, and indigestion (in up to 16% of patients), especially with initiation of therapy and rapid increases in dose. Life threatening pancreatitis has been reported to occur anywhere from shortly after initial use to after several years of use. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Hyperamylasemia has occurred in up to 20% of patients and has rarely presented as clinical pancreatitis (usually one to six months after initiation of therapy).

Severe nausea, emesis, and anorexia may be due to valproate-induced hyperammonemia or hepatitis. Adverse gastrointestinal effects may be attenuated by administering doses with food. Increased appetite and weight gain occur in approximately one half of treated patients.

Hepatic

Hepatic side effects including transient dose-dependent elevations of serum transaminases, amylase, and ammonia have been reported in up to 44% of treated patients. Dose-related hepatitis and a case of nonalcoholic liver disease have also been reported.

Some clinicians recommend monitoring liver function tests at baseline, then monthly during the first 6 months of therapy and every 3 months thereafter. Prompt withdrawal of valproic acid is recommended if significant hepatic dysfunction occurs.

Risk factors for valproic acid-associated hepatitis are young age (particularly age less than 2 years old), poor nutritional status, mental retardation, underlying metabolic disease, and concomitant use of other anticonvulsant medications. Characteristic pathological features include microvesicular steatosis.

Mild elevations in transaminases and amylase may be managed by dose reductions.

Nervous system

Neurologic side effects including drowsiness, ataxia, and hand tremor have been reported. Cases of encephalopathy (manifested by stupor, coma, hallucinations or affective changes) and chorea have also been reported. Valproate may inhibit urea synthesis resulting in hyperammonemia, which has been associated with encephalopathy, delirium, and ataxia in rare cases. Reversible sensorineural hearing loss associated with valproic acid (the active ingredient contained in Stavzor) has been reported rarely. Two cases of extrapyramidal disorders have been reported in association with valproic acid therapy. A case of truncal weakness and respiratory failure has also been associated with valproic acid therapy.

A clinical observational study has reported that valproic acid is associated with cognitive decline in HIV-infected individuals.

Loss of seizure control may indicate associated hepatitis.

Hematologic

Hematologic side effects including rare cases of reversible thrombocytopenia associated with antiplatelet antibodies and bone marrow suppression have been reported.

Some clinicians recommend monitoring complete blood counts (including platelet counts) at baseline, then monthly for three months, and every three months thereafter.

Data from a study of 265 patients strongly suggests a causal relationship between rising plasma valproic acid levels and reduced platelet counts, with additional risk factors including female gender and lower baseline platelet counts.

Dermatologic

Valproic acid has been associated with stomatitis and cutaneous leukoclastic vasculitis. A case of psoriasiform eruption has been reported in a patient receiving valproic acid (the active ingredient contained in Stavzor)

The mechanism of valproic acid induced alopecia is believed to be telogen shedding. This is believed to appear within three months of the initiation of valproic acid therapy. Alopecia does not appear to be dose related. Limited data have reported that supplements with a zinc and selenium-containing vitamin may be useful in the prevention of valproic acid associated alopecia.

Dermatologic side effects including transient alopecia (2.6% to 12%), thinning of the hair, hair color changes, hair texture changes, and rare rashes have been reported. Valproic acid has been implicated in producing Stevens-Johnson syndrome and toxic epidermal necrolysis.

Cardiovascular

Cardiovascular side effects including peripheral edema have been reported rarely.

Renal

Valproate-induced Fanconi's syndrome has been reported more often in children than in adults.

Renal side effects including several cases of Fanconi's syndrome have been reported.

Endocrine

Valproate therapy has been associated with polycystic ovaries, elevated serum testosterone concentrations and menstrual disturbances. One study has suggested that 80% of women treated with valproic acid (the active ingredient contained in Stavzor) before the age of 20 have polycystic ovaries or hyperandrogenism.

Endocrine side effects including a variety of adverse reproductive endocrine disorders have been reported in epileptic women taking valproic acid.

Respiratory

Respiratory side effects including a case of eosinophilic pleural effusion have been reported.

Immunologic

Immunologic side effects have been reported including a case of bone marrow suppression in a girl who received high dose valproic acid (the active ingredient contained in Stavzor)

Other

Other side effects including a case of valproate-withdrawal induced migraine has been reported.

Musculoskeletal

Musculoskeletal side effects including decreased bone mass and increased bone turnover have been reported.

Hypersensitivity

Hypersensitivity side effects including a case of hypersensitivity syndrome have been reported.

General

General side effects including hypothermia have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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