LYRICA® (pregabalin) CV Side Effects | Safety Information
Understanding Potential Side Effects
Can Help You Stay on Track
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. Not every 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 are dizziness and sleepiness. Across all clinical studies, dizziness occurred in 30% of LYRICA patients, compared with 8% of patients taking a placebo. Sleepiness occurred in 23% of LYRICA patients, compared with 8% of patients taking a placebo. For some people, dizziness and sleepiness went away over time. For others, these lasted throughout the course of the studies.
Other common side effects in these clinical studies included 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.
Give LYRICA time to work. It may take time for LYRICA to work. And you may feel side effects before you may start feeling an improvement. If you do experience side effects, there may be things your doctor can do to help. So be sure to talk to your doctor and keep taking LYRICA every day as prescribed by your doctor.
There are some instances where you may actually need to stop taking LYRICA. LYRICA may also 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. Otherwise, do not stop taking LYRICA without first talking to your doctor.
Do side effects go away over time?
Side effects may or may not go away. Across all clinical studies, the 2 most common side effects, dizziness and sleepiness, went away over time for some patients. For some patients, dizziness and sleepiness persisted throughout the studies.
Two Most Common Side Effects in Clinical Trials With LYRICA
Can LYRICA potentially cause weight gain?
In all clinical studies lasting up to 14 weeks, 9% of patients who were taking LYRICA gained weight, compared with 2% of patients taking a placebo.
Only 0.3% of patients in these studies decided to remove themselves from the studies because of weight gain.
*These patients gained 7% or more from their starting weight.
Take an active role in your treatment. If you are experiencing side effects, or even a little discomfort, talk to your doctor. He or she can help you manage them. Learn more about working with your doctor
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 suicidal thoughts or actions or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking.
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.
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