Most people who take Frisium (clobazam) have no side effects or mild side effects that go away in a short time with no lasting harm. Serious reactions, such as a drug-related skin rash, have been extremely rare. Call your doctor right away if you notice a rash soon after you start taking Frisium.

Like many other seizure medicines, Frisium makes some people feel sleepy or uncoordinated. If you've just started taking Frisium or have just had your dosage increased, be careful when doing things that could be dangerous until you know how it will affect you. Be especially cautious if you tend to be sensitive to medications or if you are taking another medicine that could make you sleepy.

One of the great dangers in using medications like Frisium is the tendency to increase the dose as tolerance develops. To a certain extent, this is necessary, but adverse effects may be increased more than seizure control. If the dosage is increased gradually over a long period, subtle changes in personality (such as irritability, depression, or decreased motivation) or problems such as impaired memory may go unnoticed or be considered natural for that person.

High doses sometimes are prescribed for children and adults, especially those with developmental disabilities. Problems with thinking and behavior may be the result. If the dose has been increased gradually over many months or years, it can be hard to separate the effects of the Frisium (or other benzodiazepines) from the effects of other medications, seizures, and other neurological and psychological disorders.

An important concern when people with epilepsy take Frisium or other benzodiazepines is the risk that seizures will become more frequent or more severe if the medicine is reduced or stopped. Withdrawal syndrome usually begins as soon as the patient stops taking the medicine and lasts for 8 to 10 days. The longer the person has been taking Frisium and the higher the dose, the greater the tolerance and therefore the higher the risk of worsening seizure control. Even small, gradual dose reductions can temporarily increase seizure activity, but the long-term decrease in effects like drowsiness and depression often makes the change worthwhile.

Besides increased seizure activity, other symptoms of withdrawal include:

• drowsiness
• dizziness
• poor coordination
• drooling
• restlessness or aggressiveness

Tell your doctor if you notice these symptoms when your dosage is being reduced.

On July 10, 2008, an advisory panel was convened by the Food and Drug Administration (FDA) to review data that the FDA had previously collected from drug studies showing an association between many of the antiepileptic drugs (AEDs) and suicidal ideation and behavior, which together are called suicidality. According to the FDA’s Alert, among the patients with epilepsy in these drug studies, 1 out of 1000 people taking the placebo (inactive substance) showed suicidality compared to approximately 3.5 out of 1000 people who took an AED. The FDA advisory panel voted to accept the FDA's data at its meeting on July 10. The FDA has provided the following information for patients, family members, and caregivers at www.fda.gov/cder/drug/InfoSheets/HCP/antiepilepticsHCP.htm.

• Taking antiepileptic medicines may increase the risk of having suicidal thoughts or actions;
• Do not make any changes to the medication regimen without first talking with the responsible healthcare professional;
• Pay close attention to any day-to-day changes in mood, behavior and actions. These changes can happen very quickly so it is important to be mindful of any sudden differences.
• Be aware of common warning signs that might be a signal for risk of suicide. Some of these are:
  • Talking or thinking about wanting to hurt yourself or end your life
  • Withdrawing from friends and family
  • Becoming depressed or having your depression get worse
  • Becoming preoccupied with death and dying
  • Giving away prized possessions

We again urge patients and families to contact their doctor before stopping an epilepsy medication because this may possibly lead to seizures and worsening of mood.

Reviewed July 2008 by Steven C. Schachter, MD, epilepsy.com Editorial Board.