LYRICA (LEER-i-kah) is a prescription medicine approved by the US Food and Drug Administration (FDA) 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.

In clinical studies, LYRICA was proven effective in 2 difficult-to-treat nerve pain conditions—diabetic nerve pain and pain after shingles—and fibromyalgia. LYRICA was proven to provide significant relief from pain associated with these 3 conditions for patients who took LYRICA compared with those who took a placebo.* LYRICA can also provide significant relief from spinal cord injury nerve pain.*

In clinical studies, LYRICA was also proven as an add-on therapy to significantly reduce the frequency of partial onset seizures in adults with epilepsy compared with a placebo.*

LYRICA is believed to work within your body to calm the damaged or overactive nerves that cause pain. Although the exact mechanism of action is unknown, results from animal studies suggest that LYRICA works by calming damaged or overactive nerves that cause pain or seizures. The implication of these studies in humans is not known.

LYRICA is a prescription medicine approved by the US Food and Drug Administration (FDA) and is used in adults to manage fibromyalgia (chronic pain all over your body). It is also used to treat diabetic nerve pain or pain associated with diabetic peripheral neuropathy (pain in the feet and hands from damaged nerves caused by diabetes), spinal cord injury nerve pain and pain after shingles. In addition, it is used together with other seizure medicines to treat partial onset seizures in adults with epilepsy.

Take LYRICA every day as prescribed by your doctor. Here are a few ways to help make sure you take LYRICA the right way:

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.

LYRICA is available in multiple strengths. Your doctor can adjust your dose to help you get the most from treatment. So it’s important to discuss your progress and any side effects you may feel with your doctor, especially in the first few weeks. Your healthcare provider may change your dose. Do not change your dose without talking to your doctor.

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.

Two Most Common Side Effects With LYRICA in Clinical Studies

Other side effects in these studies 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.

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.

If you stop taking LYRICA suddenly, you may have headaches, nausea, diarrhea, or trouble sleeping. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. If you and your doctor do decide you need to stop taking LYRICA, he or she will help you stop gradually.

Please see additional Important Safety Information below.

It may take time for LYRICA to work. In clinical studies in fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles, some patients experienced a decrease in pain as early as one week. For others it took longer.*

If you aren't feeling the pain relief you expect, there may be things your doctor can do to help. Talk to your doctor to find out if adjusting your dose may be right for you.

*Individual results may vary.

It’s important to give your doctor your full medical history. This will make sure you have the best possible experience with LYRICA. Before taking LYRICA, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medicines, vitamins or herbal supplements you take, especially medicines that make you sleepy or any medicines mentioned below:

LYRICA has a low potential for interaction with other medicines. Tell your doctor about all the medicines, vitamins or herbal supplements you take, especially medicines that make you sleepy or any medicines mentioned below:

Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your doctor.

Your doctor will decide what dose is appropriate for you. Everyone is unique and may respond to LYRICA differently. LYRICA is available in multiple strengths. Your doctor can adjust your dose to help you get the most from treatment. So it’s important to discuss your progress and any side effects you may feel with your doctor, especially in the first few weeks.

The approved doses for the different indications of LYRICA are as follows:

	Number of times per day to take LYRICA	Recommended total starting dosage	Recommended total ongoing dosage
Fibromyalgia	2	150 mg/day	300 mg/day to 450 mg/day
Diabetic nerve pain	3	150 mg/day	300 mg/day
Spinal cord injury nerve pain	2	150 mg/day	150 mg/day to 600 mg/day*
Pain after shingles	2 or 3 (depending on the dose)	150 mg/day	150 mg/day to 600 mg/day†
Partial onset seizures in adults with epilepsy	2 or 3 (depending on the dose)	150 mg/day	150 mg/day to 600 mg/day

Your doctor may make adjustments according to your needs. If you have problems with kidney function, your doctor may prescribe a lower dose of LYRICA.

*Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg per day, and who are able to tolerate LYRICA, may be treated with up to 600 mg per day.

^†Patients who do not experience sufficient pain relief following 2 to 3 weeks of treatment with 300 mg per day, and who are able to tolerate LYRICA, may be treated with up to 600 mg per day.

If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take LYRICA at your next regular time. Do not take 2 doses at the same time.

If you take too much LYRICA, call your doctor or poison control center, or go to the nearest emergency room right away.

Do not stop taking LYRICA without talking to your healthcare provider. If you stop taking LYRICA suddenly, you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking LYRICA suddenly, you may have seizures more often. If you and your doctor do decide you need to stop taking LYRICA, he or she will help you stop gradually.

Over 9 million people have been prescribed LYRICA in the United States since its approval in 2005. LYRICA is not appropriate for everyone.

No. LYRICA is not an antidepressant. Be sure to tell your doctor about all the medicines you are taking.

No. LYRICA is not a narcotic. But if you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.

No. There is no generic version of LYRICA.

The US government regulates the manufacture, possession, and use of certain drugs and chemicals. The Drug Enforcement Administration (DEA) maintains 5 schedules (or lists) of these controlled substances. The higher the schedule number, the lower the potential there is for abuse. For instance, LYRICA is a Schedule V medicine. This means it has a lower potential for abuse than a pain medicine such as oxycodone, which is a narcotic that falls under Schedule II.