Valproate Sodium Side Effects

Generic name: valproic acid

Medically reviewed by Drugs.com. Last updated on Oct 14, 2024.

Note: This document provides detailed information about Valproate Sodium Side Effects associated with valproic acid. Some dosage forms listed on this page may not apply specifically to the brand name Valproate Sodium.

Applies to valproic acid: oral capsule delayed release, oral capsule liquid filled, oral solution, oral syrup, oral tablet delayed release, oral tablet extended release.

Precautions

It is very important that your doctor check your or your child's progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant (especially during the first 3 months of pregnancy) can harm your unborn baby and cause serious unwanted effects (eg, brain or facial problems, heart or blood vessel problems, arm or leg problems, or intelligence or mental problems). Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

It is very important to take folic acid before getting pregnant and during early pregnancy to lower chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.

Liver problems may occur while you are using this medicine, and some may be serious. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Valproic acid may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you notice any of these side effects, tell your doctor right away.

Valproic acid may cause serious allergic reactions affecting multiple body organs (eg, liver or kidney). Check with your doctor right away if you have the following symptoms: a fever, dark urine, headache, rash, stomach pain, swollen lymph glands in the neck, armpit, or groin, unusual tiredness, or yellow eyes or skin.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.

Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, low body temperature, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Valproic acid may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This may help prevent worsening of seizures and reduce the possibility of withdrawal symptoms.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

If you plan to have children, talk with your doctor before using this medicine. Some men receiving this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Valproate Sodium

Along with its needed effects, valproic acid (the active ingredient contained in Valproate Sodium) 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:

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

Other side effects of Valproate Sodium

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:

For healthcare professionals

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

General adverse events

The most commonly reported side effects at the start of therapy include nausea, vomiting, and indigestion; these effects are usually transient. Sedative effects occur most often in patients receiving combination therapy.^[Ref]

Psychiatric

• Very common (10% or more): Nervousness
• Common (1% to 10%): Abnormal dreams, agitation, anxiety, aggression, confusion, depression, emotional lability, hallucinations, insomnia, personality disorder, thinking abnormalities
• Rare (less than 0.1%): Abnormal behavior, learning disorder, psychomotor hyperactivity
• Frequency not reported: Behavioral deterioration, hostility, psychosis
• Postmarketing reports: Emotional upset, disturbance in-attention^[Ref]

Respiratory

• Very common (10% or more): Flu syndrome, respiratory infection
• Common (1% to 10%): Bronchitis, dyspnea, epistaxis, increased cough, pharyngitis, pneumonia, rhinitis, sinusitis
• Uncommon (0.1% to 1%): Pleural effusion^[Ref]

Renal

• Rare (less than 0.1%): Reversible Fanconi's syndrome, tubulointerstitial nephritis^[Ref]

Dermatologic

• Very common (10% or more): Alopecia
• Common (1% to 10%): Discoid lupus erythematosus, dry skin, ecchymosis, furunculosis, maculopapular rash, petechia, pruritus, rash, seborrhea
• Uncommon (0.1% to 1%): Abnormal hair texture, abnormal hair growth, hair color changes, sweating
• Rare (0.01% to 0.1%): Drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
• Very rare (less than 0.01%): Acne, hirsutism
• Frequency not reported: Angioedema, generalized pruritus, photosensitivity
• Postmarketing reports: Nail and nail bed disorders^[Ref]

Endocrine

• Uncommon (0.1% to 1%): Hyperandrogenism, syndrome of inappropriate ADH secretion
• Rare (less than 0.1%): Hypothyroidism
• Very rare (less than 0.01%): Gynecomastia
• Frequency not reported: Abnormal thyroid function tests, elevated serum testosterone concentrations, parotid gland swelling, breast enlargement, galactorrhea,^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain, diarrhea, dyspepsia, gingival disorder, nausea, vomiting
• Common (1% to 10%): Constipation, dry mouth, eructation, fecal incontinence, flatulence, gastralgia, gastroenteritis, glossitis, periodontal abscess, hematemesis, stomatitis
• Uncommon (0.1% to 1%): Pancreatitis (life-threatening)^[Ref]

Cardiovascular

• Common (1% to 10%): Edema, hypertension, hypotension, palpitations, postural hypotension, peripheral edema, tachycardia, vasodilation
• Frequency not reported: Bradycardia, cutaneous vasculitis, hematoma formation^[Ref]

Genitourinary

• Common (1% to 10%): Amenorrhea, cystitis, dysmenorrhea, dysuria, enuresis, metrorrhagia, urinary incontinence, urinary frequency, vaginal hemorrhage, vaginitis
• Frequency not reported: Polycystic ovary disease

Post marketing reports: Irregular menses, secondary amenorrhea, azoospermia, aspermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology, urinary tract infection^[Ref]

Hematologic

• Very common (10% or more): Thrombocytopenia
• Common (1% to 10%): Anemia, hemorrhage
• Uncommon (0.1% to 1%): Leucopenia, pancytopenia
• Rare (less than 0.1%): Abnormal coagulation tests (e.g., prolonged prothrombin time, prolonged activated partial thromboplastin time, prolonged thrombin time, prolonged INR), agranulocytosis, bone marrow failure, decreased coagulation factors, including pure red cell aplasia, macrocytosis
• Frequency not reported: Aplastic anemia, bone marrow suppression, bruising, eosinophilia, frank hemorrhage, hypofibrinogenemia, anemia including macrocytic with or without folate deficiency, relative lymphocytosis
• Postmarketing reports: Relative lymphocytosis, macrocytosis, agranulocytosis, acute intermittent porphyria, Fanconi's syndrome^[Ref]

Hepatic

• Common (1% to 10%): Increased liver enzymes (particularly early in treatment), liver injury, SGOT increased, SGPT increased
• Frequency not reported: Severe liver damage (including hepatic failure sometimes resulting in death), increased serum bilirubin, abnormal changes in other liver function tests^[Ref]

Hypersensitivity

• Frequency not reported: Allergic reaction, anaphylaxis, hypersensitivity^[Ref]

Local

• Common (1% to 10%): Injection site pain, injection site reaction
• Uncommon (0.1% to 1%): Injection site inflammation^[Ref]

Metabolic

• Very common (10% or more): Anorexia
• Common (1% to 10%): Weight loss/gain, increased appetite, hyponatremia
• Rare (less than 0.1%): Hyperammonemia
• Frequency not reported: Acute intermittent porphyria, minor elevations of LDH (dose related), decreased carnitine concentrations, hyperglycinemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, arthrosis, leg cramps, myalgia, myasthenia, twitching
• Uncommon (0.1% to 1%): Decreased bone mineral density, osteopenia, osteoporosis and fractures on long term therapy
• Rare (less than 0.1%): Rhabdomyolysis, systemic lupus erythematosus
• Frequency not reported: Bone pain
• Postmarketing reports: Fractures, weakness^[Ref]

Nervous system

• Very common (10% or more): Dizziness, headache, somnolence, tremor
• Common (1% to 10%): Abnormal gait, amnesia, catatonic reaction, convulsion, disturbance in attention, dysarthria, extrapyramidal disorder, hypertonia, hypokinesia, incoordination, increased reflexes, memory impairment, nystagmus, paraesthesia, speech disorder, stupor, tardive dyskinesia, taste perversion
• Uncommon (0.1% to 1%): Ataxia, coma, encephalopathy, lethargy, reversible parkinsonism
• Rare (less than 0.1%): Cognitive disorder, reversible dementia associated with reversible cerebral atrophy
• Frequency not reported: Cerebral atrophy, dementia
• Postmarketing reports: Paradoxical convulsion, parkinsonism^[Ref]

Ocular

• Very common (10% or more): Amblyopia/blurred vision, diplopia
• Common (1% to 10%): Abnormal vision, conjunctivitis, diplopia, dry eyes, eye pain^[Ref]

Oncologic

• Rare (less than 0.1%): Myelodysplastic syndrome^[Ref]

Other

• Very common (10% or more): Asthenia
• Common (1% to 10%): Back pain, chills, deafness, ear disorder, ear pain, face edema, fever, malaise, otitis media, tinnitus, vertigo
• Frequency not reported: Hypothermia, weakness, hearing loss^[Ref]

See also:

Further information

Valproate Sodium side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer