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Valproate Sodium

Canadian Brand Names

Side Effects

Along with its needed effects, a medicine 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 or nurse immediately if any of the following side effects occur:

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
  • Chest pain
  • Chills
  • Confusion
  • Cough or hoarseness
  • Crying
  • Delusions
  • Dementia
  • Depersonalization
  • Diarrhea
  • 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
  • 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 and unsteady walk shakiness in the legs, arms, hands, or feet
  • Shivering
  • Sleepiness or unusual drowsiness
  • Sore throat
  • Sweating
  • Tingling of the hands or feet
  • Trembling or shaking of the hands or feet
  • Trouble with sleeping
  • Unsteadiness, trembling, or other problems with muscle control or coordination
  • Unusual bleeding or bruising
  • Unusual tiredness or weakness
  • Unusual weight gain or loss
  • Vomiting

Less common

  • Bloody nose
  • Blurred vision
  • Bruising
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Change in walking and balance
  • Clumsiness or unsteadiness
  • Constipation
  • Cough producing mucus
  • Darkened urine
  • Difficult or labored breathing
  • Dizziness
  • Excessive muscle tone
  • Fast, pounding, or irregular heartbeat or pulse
  • Fear or nervousness
  • Increased need to urinate
  • Indigestion
  • Lack of coordination
  • Large, flat, blue, or purplish patches in the skin
  • Loss of bladder control
  • Loss of strength or energy
  • Mood or mental changes
  • Muscle pain or weakness
  • Muscle stiffness
  • Muscle tension or tightness
  • Pains in the stomach, side, or abdomen, possibly radiating to the back
  • Passing urine more often
  • Pounding in the ears
  • Shortness of breath
  • Small red or purple spots on the skin
  • Sneezing
  • Sore throat
  • Stuffy nose
  • Tightness in the chest
  • Vomiting of blood or material that looks like coffee grounds
  • Wheezing
  • Yellow eyes or skin

Rare

  • False or unusual sense of well-being
  • Feeling faint, dizzy, or lightheadedness
  • Feeling of warmth or heat
  • Flushing or redness of the skin, especially on the face and neck

Some side effects 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
  • Change in vision
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • Double vision
  • Hair loss or thinning of the hair
  • Hearing loss
  • Heartburn
  • Impaired vision
  • Indigestion
  • Lack or loss of strength
  • Loss of appetite
  • Seeing double
  • Sleeplessness
  • Stomach discomfort, upset, or pain
  • Unable to sleep
  • Uncontrolled eye movements
  • Weight gain
  • Weight loss

Less common

  • Absent, missed, or irregular menstrual periods
  • Back pain
  • Belching
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • Change in taste or bad unusual or unpleasant (after) taste
  • Difficulty having a bowel movement (stool)
  • Difficulty with moving
  • Dry skin
  • Earache
  • Excess air or gas in the stomach or intestines
  • Full feeling
  • Itching of the vagina or genital area
  • Leg cramps
  • Loss of memory
  • Muscle pains or stiffness
  • Pain
  • Pain during sexual intercourse
  • Pain or tenderness around the eyes and cheekbones
  • Passing gas
  • Problems with memory
  • Rash
  • Redness or swelling in the ear
  • Stopping of menstrual bleeding
  • Swollen joints
  • Thick, white vaginal discharge with no odor or with a mild odor

Rare

  • Body aches or pain
  • Congestion
  • Tender, swollen glands in the neck
  • Trouble with swallowing
  • Voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is very important that your doctor check your 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 tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant (especially during your first trimester) can harm your unborn baby. 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. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal 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.

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 you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Valproate sodium injection may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Do not stop receiving this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely.

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.

Valproate sodium injection may cause serious allergic reactions that affect several parts of the body (e.g., liver or kidney). Check with your doctor right away if you have more than one of the following symptoms: fever; dark urine; headache; rash; stomach pain; swollen lymph glands in the neck, armpit, or groin; unusual tiredness; or yellow eyes or skin.

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

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.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will remain in place for about an hour.

Your doctor will only give you a few doses of this medicine until your condition improves. You will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valproate sodium injection in children. However, safety and efficacy have not been established in children below 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valproate sodium injection in the elderly. However, elderly patients are more likely to have unwanted effects (e.g., tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproate sodium injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Doripenem
  • Ertapenem
  • Imipenem
  • Ketorolac
  • Lamotrigine
  • Meropenem
  • Naproxen
  • Primidone
  • Vorinostat
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acyclovir
  • Aspirin
  • Betamipron
  • Carbamazepine
  • Cholestyramine
  • Clomipramine
  • Erythromycin
  • Ethosuximide
  • Felbamate
  • Fosphenytoin
  • Ginkgo
  • Lorazepam
  • Mefloquine
  • Nimodipine
  • Nortriptyline
  • Olanzapine
  • Oxcarbazepine
  • Panipenem
  • Phenobarbital
  • Phenytoin
  • Rifampin
  • Rifapentine
  • Risperidone
  • Ritonavir
  • Rufinamide
  • Topiramate
  • Zidovudine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain disease, severe or
  • Congenital metabolism disorders (born with a disease that affects metabolism) or
  • Mental retardation with severe seizure disorders—Use with caution. May increase risk for more serious side effects.
  • Head injury, acute or
  • Liver disease, history of or
  • Urea cycle disorder (genetic disorder)—Should not be used in patients with these conditions.
  • Pancreatitis (inflammation of the pancreas) or
  • Thrombocytopenia (low platelet count)—May make these conditions worse.

Description

Valproate sodium injection is used alone or together with other medicines to control certain types of seizures (convulsions) in the treatment of epilepsy. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

This medicine is available only with your doctor’s prescription.