Understanding Potential Side Effects

When starting on any new medication, it’s normal to think about side effects. When taking LYRICA, you may or may not experience side effects. But if you do, it’s important to know that there are things you and your doctor can do. No medication works the same for everyone. So be sure to work with your doctor. He or she may suggest something to help, or may decide to adjust your dose.

See below for information on potential serious side effects under "What other safety information should I know?"

What are the most common side effects of LYRICA?

The 2 most common side effects of LYRICA were dizziness and sleepiness. In clinical studies, dizziness occurred in 31% of LYRICA patients compared with 9% of patients taking a placebo. And sleepiness occurred in 22% of LYRICA patients compared with 7% of patients taking a placebo. Other side effects include dry mouth, swelling of the hands and feet, blurred vision, weight gain, trouble concentrating, and feeling "high." These side effects were generally mild to moderate, and for many people they went away over time. For some, they lasted throughout the course of the study.

When might side effects start?

Tell your doctor if you start feeling side effects. You may feel side effects before you may start feeling pain relief. If you do, there may be things your doctor can do to help. It is important to keep taking LYRICA every day as prescribed by your doctor and work with your doctor to get the most from your LYRICA experience.

LYRICA may cause serious, even life threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat, or neck, or if you have any trouble breathing, or have a rash, hives, or blisters.

Do side effects go away over time?

Side effects may or may not go away. However, in clinical studies, the 2 most common side effects, dizziness and sleepiness, went away over time for many patients. On average, dizziness went away after 2½ weeks, and sleepiness went away after approximately 5 weeks. For some patients in each study, dizziness and sleepiness lasted throughout the study.

Can LYRICA potentially cause weight gain?

In clinical studies lasting up to 14 weeks, 9% of patients who were taking LYRICA gained weight, compared with 2% of patients taking a placebo.* Patients taking LYRICA gained up to 4 pounds on average. Patients taking a placebo gained up to 1.5 pounds on average.

Only 0.3% of patients in these studies decided to remove themselves from the studies because of weight gain.

*These patients gained an average of 7% from their starting weight.

What other safety information should I know?

LYRICA may cause serious allergic reactions in some people. Stop taking LYRICA and call your doctor right away if you have swelling of the face, mouth, lips, gums, tongue, throat, or neck, or if you have trouble breathing or have a rash, hives, or blisters.

LYRICA may cause suicidal thoughts or actions in a very small number of people. Call your doctor right away if you have new or worsening depression, suicidal thoughts or actions, or unusual changes in mood or behavior.

LYRICA may cause swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.

LYRICA may cause sleepiness. Do not drive or operate machinery until you know how LYRICA affects you.

If you are experiencing side effects, talk to your doctor right away. Clearly communicating your needs to your doctor will help you get the most from your new treatment.

Please see additional important safety information below.