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.

Learn more: Managing Your Condition

LYRICA is indicated to treat fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain, and pain after shingles. LYRICA is also indicated to treat partial onset seizures in adults with epilepsy who take 1 or more drugs for seizures.

IMPORTANT SAFETY INFORMATION

LYRICA is not for everyone. 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.

Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, 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. If you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.

LYRICA may cause swelling of your hands, legs and feet, which can be serious for people with heart problems. LYRICA may cause dizziness and sleepiness. You should not drive or work with machines until you know how LYRICA affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight including blurry vision, or if you have any kidney problems or get dialysis.

Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores.

You may have a higher chance for swelling and hives if you are also taking angiotensin converting enzyme (ACE) inhibitors so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.

Before you start LYRICA, tell your doctor if you are planning to father a child, or if you are pregnant, plan to become pregnant, or are breast-feeding. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.

In studies, a specific type of blood vessel tumor was seen in mice, but not in rats. The meaning of these findings in humans is not known.

Do not stop taking LYRICA without talking to your doctor. If you stop suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.

The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

Search form

You are here