What Should I Watch for While Using Butalbital APAP Caffeine?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to the medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take the medication for a long time.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a non-medical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

You may get drowsy or dizzy when you first start taking the medication or change doses. Do not drive, use machinery, or do anything that may be dangerous until you know how the medication affects you. Stand or sit up slowly.

Do not take other medications that contain acetaminophen with this medication. Always read labels carefully. If you have questions, ask your care team or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Nausea
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.