BANZEL side effects
Caregivers of someone who has seizures associated with Lennox-Gastaut syndrome (LGS)
are often concerned with the side effects of seizure medications. Every new side
effect means another challenge to overcome.
The FDA has determined that antiepileptic drugs (AEDs) increase the risk of suicidal
thoughts or behavior in patients taking these drugs for any indication. Patients
treated with any antiepileptic drug for any indication should be monitored for depression,
suicidal behavior, or changes in mood or behavior.
BANZEL can interact with other medications. Tell your healthcare provider about
all the medicines you take, including prescription and non-prescription medicines,
vitamins and herbal supplements. Discuss any effects with your healthcare provider.
For other risks associated with the use of BANZEL, please read Information for Patients and discuss it with your healthcare
provider.
You should call your healthcare provider if your loved one experiences a rash or
other side effects. For more information, ask your healthcare provider.
In clinical studies of patients with epilepsy who were treated with BANZEL, in addition
to their existing medications, commonly experienced side effects included:
- Headache
- Dizziness
- Fatigue
- Sleepiness
- Nausea
These side effects were described as mostly mild or moderate. Side effects typically
went away in a short amount of time. Most side effects were similar for adults and
children.
Ask your healthcare provider about adding BANZEL to an existing treatment.
For additional information about risks associated with BANZEL, read the Medication Guide and the important safety
information below and discuss it with your healthcare provider.
Important Safety Information
There are risks associated with the use of BANZEL that you should know about.
We encourage you to talk to your healthcare provider about these risks.
- Patients with a history of Familial Short QT syndrome should not be treated with
BANZEL. Talk to your healthcare provider if you are unsure if this affects you or
your loved one. BANZEL has been shown to reduce the QT interval. Caution should
be used when administering BANZEL with other drugs that shorten the QT interval.
- All medications to treat seizures, including BANZEL, may cause suicidal thoughts
or actions in a very small number of people, about 1 in 500. Call your healthcare
provider right away if you or your loved one experiences new or worsening symptoms
of depression, unusual changes in mood or behavior, thoughts or actions about suicide
or self-harm, aggression, agitation, anger, anxiety, or irritability.
- Use of BANZEL has been associated with side effects such as sleepiness or feeling
tired, difficulty with coordination, dizziness, and problems with walking or movement.
- –Alcohol, in combination with BANZEL, may increase
or worsen these side effects.
- Call your healthcare provider if you or your loved one
experiences a rash. This can be a sign of a more serious condition, such as multi-organ
hypersensitivity reaction.
- You or your loved one should take BANZEL only as prescribed. Do not stop taking
BANZEL without first talking to your healthcare provider. Stopping BANZEL suddenly
can cause serious problems.
- Tell your healthcare provider about all the medications you or your loved one takes,
including prescription and non-prescription medications, vitamins, and herbal supplements.
Using BANZEL with certain medications can affect each other, causing side effects.
- In studies, the most commonly observed (≥10%) side effects with BANZEL vs placebo
(sugar pill with no medicine in it), respectively, were headache (25% vs 20%), dizziness
(17% vs 10%), feeling tired (15% vs 9%), sleepiness (13% vs 9%), and nausea (11%
vs 7%). Most of these side effects were mild to moderate in severity and typically
went away in a short amount of time.
This Web site contains information relating to various medical conditions and treatment.
Such information is provided for educational purposes only and is not meant to be
a substitute for the advice of a physician or other health care professionals. You
should not use this information for diagnosing a health problem or disease. In order
for you to make intelligent health care decisions, you should always consult with
a physician or other health care provider for you, or your loved one's, personal
medical needs.
All quotes included in this Web site represent the individual experience of some
doctors, some patients, and their caregivers. Individual responses to treatment
may vary.
This site is intended for residents of the United States only. Any products discussed
herein may have different product labeling in different countries.