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Topiramate

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 immediately if any of the following side effects occur:

More common

  • Any vision problems, especially blurred vision, double vision, eye pain, or rapidly decreasing vision
  • Burning, prickling, or tingling sensations
  • Clumsiness or unsteadiness
  • Confusion
  • Continuous, uncontrolled back-and-forth or rolling eye movements
  • Dizziness
  • Drowsiness
  • Eye redness
  • Generalized slowing of mental and physical activity
  • Increased eye pressure
  • Memory problems
  • Menstrual changes
  • Menstrual pain
  • Nervousness
  • Speech or language problems
  • Trouble in concentrating or paying attention
  • Unusual tiredness or weakness

Less common

  • Abdominal or stomach pain
  • Fever, chills, or sore throat
  • Lessening of sensations or perception
  • Loss of appetite
  • Mood or mental changes, including aggression, agitation, apathy, irritability, and mental depression
  • Red, irritated, or bleeding gums
  • Weight loss

Rare

  • Blood in the urine
  • Decrease in sexual performance or desire
  • Difficult or painful urination
  • Eye pain
  • Frequent urination
  • Hearing loss
  • Itching
  • Loss of bladder control
  • Lower back or side pain
  • Nosebleeds
  • Pale skin
  • Red or irritated eyes
  • Ringing or buzzing in the ears
  • Skin rash
  • Swelling
  • Troubled breathing

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • Blisters in the mouth
  • Blisters on the trunk, scalp, or other areas
  • Bloating
  • Clay-colored stools
  • Constipation
  • Cough
  • Diarrhea
  • Increased rate of breathing
  • Itching
  • Joint or muscle pain
  • Pain or tenderness in upper abdomen or stomach
  • Red skin lesions, often with a purple center
  • Sores, ulcers, or white spots in the mouth or on the lips
  • Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Decreased awareness or responsiveness
  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • Drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • Muscle tremors
  • Nausea
  • Rapid, deep breathing
  • Restlessness
  • Severe sleepiness
  • Stomach cramps
  • Sweating unusual

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

  • Breast pain in women
  • Tremors

Less common

  • Back pain
  • Chest pain
  • Constipation
  • Heartburn
  • Hot flushes
  • Increased sweating
  • Leg pain

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 the progress of you or your child at regular visits to see if the medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant 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 this medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for pregnant patients taking a seizure medicine.

This medicine may cause some people to have blurred vision, double vision, clumsiness or unsteadiness, or to become dizzy, drowsy, or have trouble in thinking or speaking. Make sure you know how you react to this medicine before you drive, use machines, climbing in high places, swimming, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.

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, other allergies, or colds; prescription pain medicines, or sleep medicines. Check with your doctor before taking any of the above while you are using this medicine.

Check with your doctor immediately if you or your child have a decrease in vision, blurred vision, double vision, or pain around the eyes during and after treatment with this medicine. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking topiramate. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are using topiramate. If you have any questions about this, check with your doctor or pharmacist.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine. Overheating may result in heat stroke. Also, hot baths or saunas may make you dizzy or faint while you are taking this medicine.

Topiramate 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, your child, or your caregiver notice any of these side effects, tell your or your child’s doctor right away.

This medicine may cause nausea, muscle tremors, fast breathing, problems eating, fast heartbeat, restlessness, and abdominal or stomach pain. Tell your doctor right away if you or your child have any of these symptoms. This may be a sign that you or your child may be having a metabolic acidosis (too much acid in the blood).

This medicine may cause your body temperature to go down especially when taking valproic acid, which is another medicine to control seizures. You may have tiredness, weakness, confusion, and abnormal heartbeat and breathing. Tell your doctor right away if you feel any of these side effects.

This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child’s height and weight to make sure that your child is growing properly.

Do not stop taking topiramate without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

Check with your doctor right away if you or your child are having unusual drowsiness, dullness, tiredness, weakness, or feelings of sluggishness; mental depression or anxiety; nightmares or unusually vivid dreams; or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Check with your doctor right away if you or your child have sudden back pain, abdominal or stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.

Tell your doctor if your or your child’s skin feels like it is burning, crawling, itching, or if you have numbness, prickling, “pins and needles”, or tingling feeling after using topiramate.

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

Take this medicine every day exactly as ordered by your doctor in order to improve your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Topiramate may be taken with or without food, on a full or an empty stomach.

Swallow the tablets whole. Do not break, crush, or chew them. The bitter taste may be more noticeable if the tablets are held in the mouth or chewed.

The sprinkle capsules may be swallowed whole, or the capsule may be opened and the contents be sprinkled on a small amount (teaspoonful) of soft food (such as applesauce, custard, ice cream, oatmeal, pudding, or yogurt). This mixture must be swallowed immediately without chewing.

It is important that you drink extra water every day while you take topiramate to help prevent kidney stones.

This medicine will be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules or tablets):
    • For seizures (taken with other medicines):
      • Adults—At first, 25 or 50 milligrams (mg) once a day for the first week. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 400 mg per day.
      • Children 2 years of age and older—At first, 25 milligrams (mg) nightly for the first week. Your doctor may gradually increase your dose every 1 or 2 weeks to be taken in two divided doses.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For seizures (taken alone):
      • Adults, teenagers, and children 10 years of age and older—At first, 50 milligrams (mg) once a day divided in two doses for the first week. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 400 mg per day taken in two divided doses.
      • Children 2 to 10 years of age—At first, 25 milligrams (mg) nightly for the first week. Your doctor may gradually increase your dose every week to be taken in two divided doses and as tolerated.
    • For migraine headaches:
      • Adults—At first, 25 milligrams (mg) once a day (in the evening) for the first week. Then, your doctor may increase your dose to 25 mg to be taken in the morning and 25 mg in the evening. Your doctor may gradually increase your dose every week as needed and tolerated. The dose is usually not more than 100 mg per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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 have not been performed on the relationship of age to the effects of topiramate for the treatment of seizures in children younger than 2 years of age (when used alone or together with other medicines). Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of topiramate for the prevention of migraine headaches in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of topiramate have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of topiramate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving topiramate.

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 taking 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.

  • Citalopram
  • Ketorolac
  • Metformin
  • Naproxen

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.

  • Amitriptyline
  • Carbamazepine
  • Desogestrel
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Fosphenytoin
  • Ginkgo
  • Hydrochlorothiazide
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Phenobarbital
  • Phenytoin
  • Pioglitazone
  • Posaconazole
  • Valproic Acid

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:

  • Bone problems (e.g., osteomalacia, osteoporosis, rickets) or
  • Depression, history of or
  • Eye or vision problems (e.g., glaucoma) or
  • Mental illness, history of or
  • Metabolic acidosis (too much acid in the blood), history of—Use with caution. May make these conditions worse.
  • Congenital metabolism disorders (born with a disease that affects metabolism)—Use with caution. May increase risk for more serious side effects.
  • Diarrhea or
  • Ketogenic diet (high-fat, low-protein, low-carbohydrate diet) or
  • Kidney problems or
  • Lung disease or other breathing problems or
  • Status epilepticus (e.g., a state of epilepsy where you have many seizures in a row and do not gain consciousness) or
  • Surgery—These problems may make a condition called metabolic acidosis occur or make it worse.
  • Kidney disease or
  • Liver disease—Use with caution. Higher blood levels of topiramate may result and increase the chance of side effects.

Description

Topiramate is used alone or together with other medicines to help control certain types of seizures (e.g., partial seizures, tonic-clonic seizures, or Lennox-Gastaut syndrome) in the treatment of epilepsy. This medicine cannot cure epilepsy and will only work to control seizures for as long as you continue to take it. It is also be used to help prevent migraine headaches in adults.

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