What to watch for​

When first starting PRIMAXA ODT, it’s important to listen to your body as it adjusts to treatment.

It’s common to experience mild side effects at first. The most frequent side effects are trouble with coordination or balance and dizziness.

These effects are usually temporary and fade over time as the body adjusts to PRIMAXA ODT.

Other side effects may include
  • Nausea
  • Loss of appetite
  • Vomiting
  • Feeling very tired or low on energy
  • Increased irritability
  • Mood changes or emotional ups and downs
  • Sexual problems, such as difficulty getting or keeping an erection
  • Drowsiness
  • Changes in vision, such as seeing double or uncontrolled eye movements
  • Itchy, measles-like rash that may be accompanied by fever or flu-like symptoms

If you see or suspect any of these side effects, contact your prescribing doctor immediately.

For caregivers​

Information for your doctor

Always keep a list of your or your child’s medications with you. If you need to contact your doctor about potential side effects or medication adjustments, they will need this information.

What you can do

Pay attention to how you or your child is feeling physically and emotionally while taking PRIMAXA ODT.

Tell your doctor right away if something feels off, especially in mood or behavior.

Write it down. Even small changes or mild side effects are worth noting.

Don't wait. If something feels serious, seek medical help immediately.

Did you know?

[Specialty Pharmacy] is available to answer questions about PRIMAXA ODT. Learn more about the ongoing support that’s available to you.

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INDICATION AND IMPORTANT SAFETY INFORMATION View Full

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Primaxa™ ODT?

Primaxa ODT is a medicine used to help control certain types of seizures. Like many seizure medications, Primaxa ODT can cause serious side effects in some people. Be sure to talk to your healthcare provider before starting this medication.

Serious warnings and precautions:

  • Suicidal thoughts or actions:
    Seizure medicines like Primaxa ODT may increase the risk of suicidal thoughts or behaviors. Call your healthcare provider right away if you or your caregiver notice new or worsening depression, mood changes, or thoughts of harming yourself.
  • Do not stop suddenly:
    Do not stop taking Primaxa ODT without talking to your healthcare provider. Suddenly stopping can cause serious problems, including more seizures or a life-threatening condition called status epilepticus.
  • Drowsiness and dizziness:
    Primaxa ODT can make you sleepy, dizzy, or cause problems with coordination. Do not drive or operate machinery until you know how Primaxa affects you.
  • Serious blood problems:
    Rare but serious blood disorders (such as anemia or low white blood cell counts) have been reported. Your healthcare provider may do regular blood tests to check for problems.
  • Birth defects and pregnancy risks:
    The effects of Primaxa ODT in pregnant women are not well known. Like many seizure medications, it may carry a risk of birth defects. If you are pregnant or planning to become pregnant, talk to your healthcare provider about the risks and benefits. Some women may need vitamin K during the last month of pregnancy.
  • Breastfeeding:
    Primidone and its byproducts can pass into breast milk. Talk to your provider about the risks if you are nursing. Watch for unusual drowsiness or feeding problems in your baby.
  • Phenylketonuria (PKU) warning:
    Primaxa ODT contains aspartame, which is a source of phenylalanine. People with PKU should speak with their doctor before using this medicine.
  • Do not take more than prescribed:
    The maximum dose of Primaxa ODT is 2 grams per day. It may take several weeks to see the full effects. Your doctor may order regular check-ups or lab work while you take this medication.

What are the possible side effects?

The most common side effects of Primaxa ODT include:

  • Sleepiness or drowsiness
  • Dizziness, vertigo, or balance problems
  • Nausea, vomiting, or loss of appetite
  • Blurred or double vision
  • Skin rash or itching
  • Feeling irritable, tired, or emotionally sensitive
  • Sexual side effects

Serious side effects that require immediate attention include:

  • Unusual bruising or bleeding
  • Fever or sore throat
  • Yellowing of the skin or eyes
  • Trouble breathing or chest pain
  • Thoughts of harming yourself

These are not all the possible side effects. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see full Prescribing Information for additional safety and dosing information.

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