Pregabalin

Pregabalin Molecular Structure

Pregabalin, marketed under the brand name Lyrica among others, is a medication used to treat epilepsy, neuropathic pain, fibromyalgia, and generalized anxiety disorder.

Side Effects

This information contains side effect information about pregabalin, Lyrica's active ingredient. Some of the dosage forms listed on this page may not apply to the brand name Lyrica.

Always review a drug company's prescription drug's side effects and possible drug interactions with your doctor and pharmacist.

Pregnant women must always consult with their doctor and pharmacist when taking any prescription drug, over-the-counter drug, supplement, or herbal remedy for side effects, drug interactions, and possible miscarriage, injury, birth defect, addiction, or death to the embryo, fetus, or baby. Breastfeeding women should always talk to their doctor and pharmacist for information about breast milk being laced with the drug she has taken causing side effects, injury, addiction, or death, and drug interactions to the baby consuming her breast milk.

Check with your doctor and pharmacist before using any prescription or over-the-counter drug, supplement, or herbal remedy being administered to a child. Check with your doctor and pharmacist for children's side effects or drug interactions that may not be listed.

More commonly reported ones are:

• Accidental injury
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in walking and balance
• clumsiness
• confusion
• dementia
• difficulty having a bowel movement
• difficulty with speaking
• double vision
• dry mouth
• false beliefs that cannot be changed by facts
• fever
• headache
• hoarseness
• increased appetite
• lack of coordination
• loss of memory
• lower back or side pain
• painful or difficult urination
• problems with memory
• rapid weight gain
• sensation of pins and needles
• shakiness
• sleepiness
• stabbing pain
• trembling, or other problems with muscle control or coordination
• unsteady walk
• unusual drowsiness
• unusual weight gain or loss

Less commonly reported ones are:

• Anxiety
• bloated or feeling of fullness
• chest pain
• cold sweats
• cool, pale skin
• cough producing mucus
• decrease or change in vision
• depression
• excess air or gas in the stomach or intestines
• eye disorder
• false or unusual sense of well-being
• general feeling of discomfort or illness
• increased hunger
• loss of appetite
• loss of bladder control
• loss of consciousness
• loss of strength or energy
• muscle aches, twitching or jerking, or weakness
• nausea
• nervousness
• nightmares
• noisy breathing
• pain
• passing gas
• rhythmic movement of the muscles
• runny nose
• seizures
• shivering
• slurred speech
• sweating
• trouble sleeping
• twitching
• uncontrolled eye movements
• vomiting

Other less commonly reported ones are:

• Difficult or labored breathing
• tightness in the chest

Rarely reported ones are:

• Blistering, peeling, or loosening of the skin
• chills
• cough
• diarrhea
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• joint or muscle pain
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• unusual tiredness or weakness

Generic legal battle

• Mar 2012, Pfizer blocked Israel-based Teva Pharmaceutical Industries and other manufacturers from selling generic versions of Lyrica.

• Jul 2012, the U.S. Food and Drug Administration (FDA) approved a generic version of Lyrica. Pregabalin, the active ingredient, is the generic name. Two weeks after being approved by the FDA, marketing was blocked.

• 2014, Pfizer Inc., the maker of Lyrica, successfully blocked the marketing of Pregabalin generics until December of 2018 arguing that the generics should not be marketed and made available until their patent ran out. Warner-Lamber, (a subsidieary of Pfizer), "still holds a “second medical use” patent for the use of pregabalin in the treatment of peripheral and central neuropathic pain, which expires in July 2017. A second medical use patent is one that relates to a new medical use for a known compound."
• Nov 2018, Pfizer Receives Six Months Pediatric Exclusivity For Lyrica® (Pregabalin)

Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for LYRICA^®. This grant extends the period of U.S. market exclusivity for LYRICA by an additional six months, to June 30, 2019.

See also

• Fibromyalgia

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

adverse reaction Any unintended or unwanted response to a treatment, whether in a clinical trial or licensed treatment. May be minor or serious.

BMJ The BMJ (previously the British Medical Journal) is a weekly peer-reviewed medical journal.