Pregabalin Side Effects
Some side effects of pregabalin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to pregabalin: oral capsule, oral solution
Along with its needed effects, pregabalin 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
- shortness of breath
- tightness in the chest
- Blistering, peeling, or loosening of the skin
- difficulty with swallowing
- fast heartbeat
- 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
- skin rash
- 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
- 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
- difficulty having a bowel movement (stool)
- difficulty with speaking
- double vision
- dry mouth
- increased appetite
- lack of coordination
- loss of memory
- lower back or side pain
- painful or difficult urination
- problems with memory
- rapid weight gain
- seeing double
- sensation of pins and needles
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- stabbing pain
- tingling of the hands or feet
- trembling, or other problems with muscle control or coordination
- unusual weight gain or loss
- bloated or full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain
- cold sweats
- cool, pale skin
- cough producing mucus
- decrease or change in vision
- 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
- joint pain
- loss of appetite
- loss of bladder control
- loss of strength or energy
- muscle aches and pains
- muscle twitching or jerking
- muscle weakness
- noisy breathing
- passing gas
- rhythmic movement of the muscles
- runny nose
- slurred speech
- trouble sleeping
- uncontrolled eye movements
For Healthcare Professionals
Applies to pregabalin: oral capsule, oral solution
Nervous system side effects including dizziness (up to 38%), somnolence (up to 28%), ataxia (up to 20%), tremor (up to 11%), neuropathy (up to 9%), abnormal thinking (up to 9%), abnormal gait (up to 5%), confusion (up to 7%), speech disorder (up to 7%), amnesia (up to 6%), incoordination (up to 6%), twitching (up to 5%), vertigo (up to 4%), myoclonus (up to 4%), euphoria (up to 3%), and nervousness (up to 1%) have been reported. Anxiety, depersonalization, hypertonia, hypesthesia, decreased libido, nystagmus, paresthesia, stupor, and twitching have been reported frequently. Abnormal dreams, agitation, apathy, aphasia, circumoral paresthesia, dysarthria, hallucinations, hostility, hyperalgesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, increased libido, myoclonus, and neuralgia have been reported infrequently. Addiction, cerebellar syndrome, cogwheel rigidity, coma, delirium, delusions, dysautonomia, dyskinesia, dystonia, encephalopathy, extrapyramidal syndrome, Guillain-Barre syndrome, hypoalgesia, intracranial hypertension, manic reaction, paranoid reaction, peripheral neuritis, psychotic depression, schizophrenic reaction, torticollis, and trismus have been reported rarely.
Metabolic side effects including peripheral edema (up to 16%), weight gain (up to 16%), edema (up to 6%), and hypoglycemia (up to 3%) have been reported. Decreased glucose tolerance and urate crystalluria have been reported rarely.
Gastrointestinal side effects including dry mouth (up to 15%), constipation (up to 7%), increased appetite (up to 6%), vomiting (up to 3%), flatulence (up to 3%), nausea and diarrhea have been reported. Gastroenteritis has been reported frequently. Cholecystitis, cholelithiasis, colitis, dysphagia, esophagitis, gastritis, gastrointestinal hemorrhage, melena, mouth ulceration, pancreatitis, rectal hemorrhage, and tongue edema have been reported infrequently. Aphthous stomatitis and esophageal ulcer have been reported rarely.
General side effects including infection (up to 14%), accidental injury (up to 11%), headache (up to 9%), asthenia (up to 7%), pain (up to 5%), chest pain (up to 4%), facial edema (up to 3%), flu syndrome (up to 2%), and back pain (up to 2%) have been reported. Abdominal pain and fever have been reported frequently. Abscess, cellulitis, chills, malaise, neck rigidity, overdose, pelvic pain, photosensitivity reaction, and suicide attempt have been reported infrequently. Ascites, granuloma, hangover effect, intentional injury, retroperitoneal fibrosis, shock, and suicide have been reported rarely.
Ocular side effects including visual field changes (13%), reduced visual acuity (7%), and blurred vision (6%) have been reported. Conjunctivitis and diplopia have been reported frequently. Abnormality of accommodation, blepharitis, dry eyes, eye hemorrhage, hyperacusis, photophobia, retinal vascular disorder, and retinal edema have been reported infrequently. Anisocoria, blindness, corneal ulcer, exophthalmos, extraocular palsy, iritis, keratitis, keratoconjunctivitis, miosis, mydriasis, night blindness, ophthalmoplegia, optic atrophy, papilledema, parosmia, ptosis, and uveitis have been reported rarely.
Blurred vision resolved in the majority of cases with continued dosing. Less than 1% of patients discontinued pregabalin treatment due to vision related events (primarily blurred vision).
Patients should be informed that they should notify their physician if changes in vision occur. If visual disturbance persists, further assessment should be considered. Furthermore, more frequent assessment should be considered for patients who are already routinely monitored for ocular conditions.
In a cohort study of 333 diabetic patients who received pregabalin for at least 2 years, the average weight gain was 5.2 kg. Pregabalin associated weight gain was related to dose and duration or exposure.
Other side effects including weight gain have been reported. In controlled clinical trials of up to 13 weeks, weight gain of 7% or more over baseline has been reported in 8% of pregabalin-treated patients. Otitis media and tinnitus have been reported frequently. Taste loss, and taste perversion have been reported infrequently.
Cardiovascular side effects including edema, primarily peripheral edema (6%) have been reported. Deep thrombophlebitis, heart failure, hypotension, syncope, and postural hypotension have been reported infrequently. Depressed ST and ventricular fibrillation have been reported rarely. There have been postmarketing reports of angioedema and headache.
Specific 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. Pregabalin should be discontinued immediately in patients with these symptoms. Caution is recommended if prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, 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.
Respiratory side effects including dyspnea (up to 3%) and bronchitis (up to 3%) have been reported. Apnea, atelectasis, bronchiolitis, hiccup, laryngismus, lung edema, lung fibrosis, and yawn have been reported rarely.
Genitourinary side effects including urinary incontinence (up to 2%) have been reported. Anorgasmia, impotence, and urinary frequency have been reported frequently. Abnormal ejaculation, albuminuria, amenorrhea, dysmenorrhea, dysuria, hematuria, kidney calculus, leukorrhea, menorrhagia, metrorrhagia, nephritis, oliguria, and urinary retention have been reported infrequently. Acute kidney failure, balanitis, bladder neoplasm, cervicitis, dyspareunia, epididymitis, female lactation, and glomerulitis have been reported rarely. Unilateral painful gynecomastia has been reported postmarketing.
Musculoskeletal side effects including myasthenia (1%) have been reported. Arthralgia, leg cramps, myalgia, and myasthenia have been reported frequently. Arthrosis has been reported infrequently. Generalized spasm has been reported rarely.
Oncologic side effects including an unexpectedly high incidence of hemangiosarcoma have been reported in animal studies after pregabalin was given their diet for two years. In clinical studies comprised of 6,396 patient-years of exposure, new or worsening-preexisting tumors were reported in 57 patients. It is not known if the incidence seen in these clinical studies is or is not affected by treatment.
Hypersensitivity side effects including allergic reactions have been reported frequently. Allergic reactions have included skin redness, blisters, hives, rash, dyspnea, and wheezing. Pregabalin should be discontinued immediately in patients with these symptoms. Anaphylactoid reactions have been reported rarely.
Hematologic side effects including ecchymosis have been reported frequently. Anemia, eosinophilia, hyperchromic anemia, leukocytosis, leukopenia, lymphadenopathy, and thrombocytopenia have been reported infrequently. Myelofibrosis, polycythemia, decreased prothrombin, purpura, and thrombocytopenia have been reported rarely.
Dermatologic side effects including pruritus have been reported frequently. Alopecia, dry skin, eczema, hirsutism, skin ulcer, urticaria, and vesiculobullous rash have been reported infrequently. Angioedema, exfoliative dermatitis, lichenoid dermatitis, melanosis, petechial rash, purpuric rash, pustular rash, skin atrophy, skin necrosis, skin nodule, Stevens-Johnson syndrome, and subcutaneous nodule have been reported rarely.
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