Note: This document contains side effect information about pregabalin. Some of the dosage forms listed on this page may not apply to the brand name Lyrica.

In Summary

Common side effects of Lyrica include: infection, ataxia, blurred vision, constipation, diplopia, dizziness, drowsiness, fatigue, headache, peripheral edema, tremor, weight gain, visual field loss, accidental injury, and xerostomia. Other side effects include: abnormal gait, abnormality in thinking, amnesia, arthralgia, asthenia, cognitive dysfunction, confusion, edema, neuropathy, sinusitis, speech disturbance, vertigo, visual disturbance, myasthenia, amblyopia, increased appetite, and twitching. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pregabalin: oral capsule, oral solution, oral tablet extended release

Along with its needed effects, pregabalin (the active ingredient contained in Lyrica) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking pregabalin:

Less common

• Difficult or labored breathing
• tightness in the chest

Rare

• Blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• 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

Some side effects of pregabalin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Accidental injury
• blurred vision
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in walking and balance
• clumsiness
• confusion
• 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
• poor insight and judgment
• problems with memory or speech
• rapid weight gain
• sensation of pins and needles
• shakiness
• sleepiness
• stabbing pain
• trembling, or other problems with muscle control or coordination
• trouble recognizing objects
• trouble thinking and planning
• unsteady walk
• unusual drowsiness
• unusual weight gain or loss

Less common

• 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 bowels
• 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

For Healthcare Professionals

Applies to pregabalin: oral capsule, oral solution, oral tablet extended release

General

The most common adverse reactions to this drug are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention); the more commonly reported events in pediatric patients include increased weight and increased appetite.

Nervous system

Very common (10% or more): Dizziness (up to 37%), somnolence (up to 25%)

Common (1% to 10%): Neuropathy, ataxia, vertigo, incoordination, tremor, abnormal gait, headache, speech disorder, twitching

Uncommon (0.1% to 1%): Syncope, stupor, myoclonus, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, hyporeflexia, hyperesthesia, burning sensation, ageusia, malaise

Rare (less than 0.1%): Convulsions, parosmia, hypokinesia, dysgraphia, shock, circumoral paresthesia, dysarthria, hyperalgesia, hyperkinesia, hypokinesia, hypotonia, myoclonus, neuralgia cerebellar syndrome, cogwheel rigidity, coma, dysautonomia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypalgesia, intracranial hypertension, torticollis, trismus, peripheral neuritis

Postmarketing reports: Coma

Among pediatric patients receiving this drug for the treatment of partial onset seizures, somnolence was reported in 21% of drug treated patients and 14% of placebo patients, occurring more frequently at higher doses. Somnolence includes related terms of lethargy, sluggishness, and hypersomnia.

Patients treated for central neuropathic pain due to spinal cord injury have experienced an increased incidence of CNS adverse effects, especially somnolence. This may be due to an additive effect with concomitant medications.

There are postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant agents.

Cardiovascular

Very common (10% or more): Peripheral edema (up to 12%)

Common (1% to 10%): Chest pain

Uncommon (0.1% to 1%): Hypotension, hypertension, hot flushes, flushing, peripheral coldness, heart failure, postural hypotension, syncope

Rare (less than 0.1%): ST depressed, ventricular fibrillation

Frequency not reported: PR interval prolongation

In controlled clinical trials in adult patients, peripheral edema was reported in 6% of patients receiving this drug compared with 2% in the placebo group; 0.5% and 0.2% of patients withdrew due to peripheral edema in the drug treated group and the placebo group, respectively.

Analyses of clinical trial ECG data has shown the mean PR interval increase was 3 to 6 msec at doses greater than or equal to 300 mg/day. Subgroup analyses did not identify an increased risk of PR prolongation in patients with baseline PR prolongation or those taking other PR prolonging medications, although the number of patients in the study was not sufficient to draw a definitive conclusion.

Psychiatric

Common (1% to 10%): Confusion, euphoria, amnesia, nervousness, irritability, disorientation, insomnia, libido decreased, disturbance in attention, anxiety, depersonalization, stupor, abnormal thinking

Uncommon (0.1% to 1%): Cognitive disorder, mental impairment, abnormal dreams, agitation, apathy, aphasia, hallucinations, hostility

Rare (less than 0.1%): Delirium, delusions, manic reaction, paranoid reaction, personality disorder, psychotic depression, schizophrenic reaction, sleep disorder, disinhibition

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Rare (0.01% to 0.1%): Allergic reaction, anaphylactic reaction

Dermatologic

Symptoms of angioedema have included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There have also been reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Therapy should be discontinued immediately in patients with these symptoms. Caution is recommended if this drug is used in patients who have had a previous episode of angioedema. Patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE inhibitors]) may be at increased risk of developing angioedema.

Common (1% to 10%): Ecchymosis, pruritus

Uncommon (0.1% to 1%): Angioedema, rash papular, urticaria, hyperhidrosis, abscess, cellulitis, alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, vesiculobullous rash

Rare (less than 0.1%): Stevens Johnson syndrome, cold sweat, angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, nail disorder, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, subcutaneous nodule

Gastrointestinal

Common (1% to 10%): Dry mouth, constipation, nausea, vomiting, diarrhea, flatulence, abdominal distention, gastroenteritis

Uncommon (0.1% to 1%): Gastroesophageal reflux disease, salivary hypersecretion, hypoesthesia oral, cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, GI hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, tongue edema

Rare (less than 0.1%): Ascites, granuloma

Postmarketing reports: Reduced lower gastrointestinal function events (e.g., intestinal obstruction, paralytic ileus, constipation)

Postmarketing reports of reduced lower gastrointestinal function events have been reported when co-administered with medications that have the potential to produce constipation, such as opioids.

Genitourinary

Common (1% to 10%): Urinary incontinence, erectile dysfunction, impotence, urinary frequency, urinary incontinence

Uncommon (0.1% to 1%): Sexual dysfunction, ejaculation delayed, dysmenorrhea, breast pain, anorgasmia, albuminuria, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, oliguria, urinary retention, urine abnormality, abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, kidney calculus, menorrhagia, metrorrhagia, oliguria

Rare (less than 0.1%): Breast discharge, breast enlargement, gynecomastia, pelvic pain, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, glomerulitis, ovarian disorder

Hematologic

Uncommon (0.1% to 1%): Neutropenia, blood creatine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased, blood creatinine increased, blood potassium decreased, deep thrombophlebitis

Rare (less than 0.1%): White blood cell count decreased, anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocytopenia

Rare (0.01% to 0.1%): Myelofibrosis, polycythemia, prothrombin decreased, purpura

Immunologic

Very common (10% or more): Infection (up to 14%)

Common (1% to 10%): Influenza syndrome

Musculoskeletal

Common (1% to 10%): Myasthenia, muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, leg cramps

Uncommon (0.1% to 1%): Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness, neck rigidity, arthrosis

Rare (less than 0.1%): Rhabdomyolysis, chondrodystrophy, generalized spasm

Ocular

Very common (10% or more): Visual field changes (13%)

Common (1% to 10%): Blurry vision, abnormal vision, diplopia, conjunctivitis

Uncommon (0.1% to 1%): Peripheral vision loss, visual disturbance, eye swelling, visual field defect, visual acuity reduced, eye pain, asthenopia, photopsia, photosensitivity reaction, dry eye, lacrimation increased, eye irritation, retinal vascular disorder, abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal edema

Rare (0.01% to 0.1%): Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness, anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, uveitis

Other

Common (1% to 10%): Asthenia, accidental injury, face edema, pain, otitis media, tinnitus

Uncommon (less than 0.1% to 1%): Generalized edema, pain, pyrexia, chills, thirst

Rare (0.01% to 0.1%): Retroperitoneal fibrosis, retinal vascular disorder, taste loss, taste perversion

Frequency not reported: Withdrawal effects following rapid discontinuation

Some patients have reported withdrawal effects following abrupt/rapid discontinuation. These symptoms included insomnia, nausea, headache, anxiety, hyperhidrosis, and diarrhea.

Respiratory

There are postmarketing reports of respiratory failure and coma in patients taking pregabalin (the active ingredient contained in Lyrica) and other CNS depressant agents.

Common (1% to 10%): Dyspnea, bronchitis, nasopharyngitis

Uncommon (0.1% to 1%): Epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness

Rare (less than 0.1%): Pulmonary edema, throat tightness, apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung fibrosis, yawn

Postmarketing reports: Respiratory failure

Metabolic

Common (1% to 10%): Weight gain, edema, hypoglycemia, increased appetite

Uncommon (0.1% to 1%): Weight decreased, blood glucose increased

Rare (0.01% to 0.1%): Glucose tolerance decreased, urate crystalluria

Hepatic

Uncommon (0.1% to 1%): Nephritis

Rare (0.01% to 0.1%): Acute kidney failure, pyelonephritis

Endocrine

Postmarketing reports: Gynecomastia, breast enlargement