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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: pregabalin (pree-GA-buh-luhn)
Brand name(s): LYRICA
GENERIC: not available FAMILIES: Drugs for Epilepsy, Non-Narcotic Painkillers
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

Use of pregabalin by men may cause fetal abnormalities passed through the father.

In animal studies, pregabalin passed into the placenta and caused fetal abnormalities. There are no adequate and well-controlled studies of pregabalin in pregnant women, so women who are pregnant should exercise caution.[1]

Breast-feeding Warning

It is not yet known whether pregabalin is present in the milk of lactating women, but it has been found in the milk of animals given this drug. Women who breast-feed should exercise caution. Safety and effectiveness in children has not been established.[1]

Facts About This Drug [top]

Pregabalin (LYRICA) was approved by the Food and Drug Administration (FDA) in 2004 to treat neuropathic pain (sharp, severe pain originating along the course of a nerve) in diabetics with peripheral neuropathy, patients with post-herpes (shingles) pain and patients experiencing partial-onset seizures. In 2007, it also was approved to treat fibromyalgia (muscle pain, stiffness and fatigue).[2]

Despite the FDA's decision to approve this drug to treat these types of neuropathic pain, we...

Pregabalin (LYRICA) was approved by the Food and Drug Administration (FDA) in 2004 to treat neuropathic pain (sharp, severe pain originating along the course of a nerve) in diabetics with peripheral neuropathy, patients with post-herpes (shingles) pain and patients experiencing partial-onset seizures. In 2007, it also was approved to treat fibromyalgia (muscle pain, stiffness and fatigue).[2]

Despite the FDA's decision to approve this drug to treat these types of neuropathic pain, we recommend that you not use it for these purposes.

Pregabalin may control these conditions, but it does not cure them, nor any off-label conditions for which it may be prescribed. It belongs to the same family as gabapentin (NEURONTIN), a drug that was illegally promoted for many off-label uses despite a lack of evidence of its effectiveness for these indications.[3]

Patients taking pregabalin should start with the lowest recommended dose. If necessary, the prescribing physician should increase the dose gradually. People with kidney problems or who are on dialysis may need dose adjustments.[3],[4]

Adverse effects

Common adverse effects of pregabalin include dizziness, vision changes and weight gain, which can be rapid and dramatic.[5] This drug is a controlled substance with a potential for abuse.[6] Adverse effects, including muscle twitches, occur more frequently with higher doses.[7]

Pregabalin may decrease platelets or cause fluid retention.[1],[8]

If you are stopping use of pregabalin, follow your doctor's instructions to lower the dose of the drug gradually over one week. Otherwise, seizures may occur.[1] There have been reports of brain swelling due to abruptly stopping use of pregabalin.[9]

There have been case reports of worsening chronic heart failure in patients using pregabalin.[10] Prescrire International published an article in 2014 on reports of cardiac adverse effects, including abnormal heart rhythms, in patients taking pregabalin.[11] Pregabalin should be used with caution in patients with heart failure and other types of heart disease.[12]

Studies say...

A 2006 study presented evidence of erectile dysfunction in men using pregabalin. This study was co-authored by a researcher from Pfizer, manufacturer of pregabalin and sildenafil (VIAGRA). The report contains previously unpublished Pfizer data showing significant increases in sexual dysfunction in both men and women using pregabalin compared with those using a placebo. For men, there were significant increases in impotence and decreased libido. For women, there were significant increases in anorgasmia (failure to have an orgasm) and decreased libido.[13]

In 2016, CNS Drugs published a systematic review of the potential risk of abuse associated with pregabalin.[14]

Pregabalin for Pain: Do Not Use

Pregabalin has three approved uses for pain:

  • Management of peripheral neuropathy in people with diabetes. This type of pain occurs in about 15% of people with diabetes.[15],[16],[17],[18]
  • Management of postherpetic neuralgia, a pain that lasts for three months after a rash due to herpes. This happens to about 10% of people who have herpes zoster. The pain often disturbs sleep.[19],[20],[21],[22]
  • Management of fibromyalgia

The primary FDA reviewer responsible for the applications for approval of pregabalin for diabetic neuropathy and postherpetic neuralgia concluded that the drug should not be approved for these indications. In his discussion of the application for postherpetic neuralgia, he stated that "overall the risk of adverse effects of treatment approach or exceed the likelihood of treatment benefit." Similarly, he recommended against the approval for diabetic neuropathy, stating that "it does not appear that the benefits of the drug in patients with diabetic neuropathy outweigh the risks."

The reviewer's concerns about risks involved statistically significant increases in visual abnormalities in patients using pregabalin as well as a higher incidence of accidental injuries and edema. Among pregabalin users, there was a 4.3-fold increase in blurred vision and a 6.7-fold increase in double vision compared with those taking a placebo. Accidental injuries occurred nine times more frequently in pregabalin users. One possible explanation for the increased injuries is significant increases in dizziness and abnormal gait in people using pregabalin.

Despite the reviewer's concerns, his supervisors overruled him and the drug was approved for these two indications.[23] After the drug's approval, one review of its performance rated the evidence for pregabalin for neuropathic pain as "limited."[24]

We oppose the use of pregabalin for treatment of fibromyalgia because it is not clear that the benefits of using the drug for this difficult-to-define condition clearly outweigh the risks.

Pregabalin is often prescribed for sciatica, a type of neuropathic pain characterized by aching, burning or sharp pain sensations that typically occur on one side of the body and radiate from the buttock down the back or side of the leg. The drug has not been approved by the FDA for this use. In 2017, the New England Journal of Medicine published results of a clinical trial showing that pregabalin was not effective in treating sciatica and was associated with an increased risk of harm.[25]

Pregabalin for partial-onset seizures: Limited Use

Pregabalin is approved as a treatment to supplement the effects of another drug for partial-onset seizures. It can be used with other antiseizure medications such as carbamazepine (CARBATROL, TEGRETOL), lamotrigene (LAMICTAL), phenytoin (DILANTIN) or valproic acid to increase their overall effectiveness.[26]

Many patients who experience partial-onset seizures have an inadequate response to available drugs. Up to 12% of adults facing this condition may become seizure-free with pregabalin.[27],[28],[29],[7],[30]

Regulatory actions surrounding pregabalin

In 2008 the FDA issued a warning that there have been reports of suicidal behavior or ideation associated with the use of antiepileptic drugs including pregabalin. According to the study, patients receiving these drugs had twice the risk of suicidal behavior or ideation compared with patients receiving placebo, and this increased risk was observed as early as one week after starting the drug.[31]

In 2008, the FDA issued another advisory stating that it had completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders and other conditions. Based on the outcome of this review, the FDA is requiring that all manufacturers of drugs in this class include a warning in their labeling and develop a Medication Guide to be provided to patients who are prescribed these drugs to inform them of the risks of suicidal thoughts or actions.[32]

In 2019, the Medicines and Healthcare products Regulatory Agency (a regulatory agency in the U.K. similar to the FDA) announced that pregabalin is now classified as a controlled substance.[33]

In 2019, Health Canada (a regulatory agency in Canada similar to the FDA) issued an advisory that there is an increased risk of adverse effects, including opioid overdose, when gabapentin or pregabalin is used together with opioid medications.[34]

In 2019, the FDA issued an advisory that serious breathing problems can occur when gabapentin or pregabalin is used in the elderly and in patients who are at risk of breathing difficulties, including those taking opioids and other drugs that depress breathing through their effects on the central nervous system.[35] The agency also required that the product labeling be updated to include a warning about this risk.[36]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • Allergies, including lactose
  • Blood problems
  • Drug abuse
  • Heart problems
  • Kidney problems, including dialysis treatments
  • Are pregnant or breast-feeding;
  • Or if you take any other prescription drugs, over-the-counter drugs, herbs or vitamins

When You Use This Drug [top]

  • Do not drive or do tasks requiring mental alertness and good vision until you know how you react to this drug.   
  • Drink water to avoid dehydration if you develop diarrhea, nausea, or vomiting.
  • If you have diabetes, look for skin changes, such as ulcers.
  • Watch your diet to avoid gaining weight.

How to Use This Drug [top]

  • Take with or without food. It is best to be consistent.
  • If you miss a dose, take as soon as possible, unless it is almost time for the next dose.
  • Do not double doses.
  • Check with your doctor before stopping pregabalin, as the dose should be tapered gradually over at least one week.
  • Store at room temperature. Keep out of the reach of children.

Interactions with Other Drugs [top]

Evaluations of Drug Interactions 2005 did not yet list pregabalin. The FDA-approved professional labeling and other medical references caution against use with certain drugs for diabetes. Other drugs, especially drugs in the same family, may also interact with this drug. As the number of new drugs approved for marketing increases and as more experience is gained with these drugs over time, new interactions may be discovered.[1],[37]

ACTOLUS MET, ACTOS, AVANDAMET, AVADARL, AVANDIA, pioglitazone,   rosiglitazone, thiazolidinedione

Interactions with central nervous system (CNS) drugs have not been shown to be clinically significant.[29] People who take these drugs, especially high doses, should be aware of the potential interaction:[1]

alcohol, ATIVAN, benzodiazepines, lorazepam, narcotics, oxycodone, OXYCONTIN

Adverse Effects [top]

Call your doctor if you develop:

  • Confusion, abnormal thinking
  • Difficulty concentrating
  • Dizziness
  • Drowsiness, fatigue
  • Fever
  • Lack of coordination 
  • Memory loss
  • Muscle tenderness, twitching, spasms, or weakness
  • Pain in back, chest or muscle
  • Swelling of face, feet, and legs
  • Vision blurs, double, or changes
  • Weakness

Signs of Overdose: same as other adverse effects

Call your doctor if these symptoms continue or are bothersome:

  • Constipation
  • Dry mouth
  • Skin ulcers
  • Weight gain that is undesirable

Signs of withdrawal or stopping the drug suddenly: diarrhea, headache, insomnia, nausea, seizures

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • Eye tests
  • Kidney function tests
  • Monitoring of weight

last reviewed February 28, 2021