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

Applies to pregabalin: oral capsules, oral extended-release tablets, oral oral solution.

Side effects include:

Conventional preparation in adults: Dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, abnormal thinking (primarily difficulty with concentration/attention).

Conventional preparation in pediatric patients: Somnolence, weight gain, increased appetite.

Extended-release preparation in adults: Dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, weight gain.

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.^[Ref]

Nervous system

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 (the active ingredient contained in Lyrica CR) and other CNS depressant agents.^[Ref]

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^[Ref]

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^[Ref]

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.^[Ref]

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^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Rare (0.01% to 0.1%): Allergic reaction, anaphylactic reaction^[Ref]

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.^[Ref]

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^[Ref]

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)^[Ref]

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.^[Ref]

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^[Ref]

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^[Ref]

Immunologic

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

Common (1% to 10%): Influenza syndrome^[Ref]

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^[Ref]

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^[Ref]

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^[Ref]

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

Respiratory

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^[Ref]

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

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^[Ref]

Hepatic

Uncommon (0.1% to 1%): Nephritis

Rare (0.01% to 0.1%): Acute kidney failure, pyelonephritis^[Ref]

Endocrine

Postmarketing reports: Gynecomastia, breast enlargement