Only in certain circumstances should you should stop taking Lyrica or Lyrica CR (pregabalin) right away. You should stop taking this medicine if:

• you have been directed by your doctor to stop treatment immediately
• you are having a severe, life-threatening allergic reaction
• you have developed angioedema (swelling and build-up of fluid under your skin, usually in the facial or gential area)
• you are having trouble breathing (for example: shortness of breath, wheezing)

If any of these reactions do occur, stop taking the medicine and call your healthcare provider or emergency medical services (911) right away. If you are not sure if you should stop, call your healthcare provider.

Otherwise, talk to your doctor before you decide to stop taking Lyrica or Lyrica CR. If treatment must be stopped, your doctor will slowly discontinue (taper) your medication dose over a period of time, usually over at least a week, to help lower the risk of withdrawal side effects.

With many medications, especially those that work in the brain, suddenly stopping the medicine may lead to unpleasant reactions. Also, if you have epilepsy, stopping treatment rapidly may cause seizures to occur.

With Lyrica or Lyrica CR (pregabalin) withdrawal side effects may include:

• headaches
• upset stomach or nausea
• diarrhea
• trouble sleeping
• increased sweating
• feeling anxious

How do I recognize angioedema or allergic reactions?

While most serious side effects with Lyrica (pregabalin) occur in only a very small number of people, it is important you are aware of them.

Serious, possibly life-threatening allergic reactions like angioedema or other allergic reactions can occur with Lyrica or Lyrica CR. You may be having an allergic reaction that requires immediate care if you notice:

• swelling of your face, mouth, lips, gums, tongue, throat, neck or genitals
• you are having trouble breathing (shortness of breath, wheezing)
• you have a rash, hives (raided bumps) or blisters.

Patients or caregivers should stop the use of Lyrica or Lyrica CR if you have any of these symptoms AND call the doctor (or 911) immediately if you suspect any serious allergic reactions.

What common side effects should I expect with Lyrica / Lyrica CR?

As with most drugs, Lyrica (pregabalin) has common side effects. In at least 5% of adults, Lyrica has been associated with:

• drowsiness
• dizziness
• lack of coordination (ataxia)
• weight gain
• dry mouth
• blurred vision
• swelling of hands or feet, edema
• trouble concentrating

Lyrica CR has similar side effects as seen with Lyrica, but may also cause nausea. In children being treated for seizures, the most common Lyrica side effects are increased appetite and weight gain.

This is not a complete list of side effects or warnings with Lyrica or Lyrica CR.

Is Lyrica a controlled substance?

In the U.S. Lyrica and Lyrica CR are classified as a schedule V controlled substance because there have been reports of euphoria (for example: excitement or happiness) in up to 12% of patients in reports. Because this may a feeling of a "high", Lyrica has the potential for abuse or misuse.

Also, do not drink alcohol while taking these medicines. Alcohol can affect pregabalin, the active ingredient, and increase side effects such as sleepiness and dizziness. Do not drive a car, operate machinery, or do other dangerous activities until you know how these drugs affect you.

This is not all the information you need to know about Lyrica or Lyrica CR (pregabalin) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.