According to the experience of clinical use of pregabalin in more than 12,000 patients, dizziness and drowsiness were the most common adverse events of taking Lyrica. The observed phenomena were usually mild or moderate. The frequency of pregabalin discontinuation and placebo due to adverse reactions was 14 and 7%, respectively. The main adverse effects requiring cessation of treatment were dizziness (4%) and drowsiness (3%), depending on their subjective tolerance.
Other side effects that also lead to Lyrica withdrawal are ataxia, confusion, asthenia, impaired attention, blurred vision, impaired coordination, peripheral edema.
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Listed below are all adverse events whose frequency was higher than that in the placebo group (observed in more than 1 person). They are distributed according to system-organ classes and frequency: very often – ≥1 / 10; often – ≥1 / 100, <1/10; infrequently – ≥1 / 1000, <1/100; rarely <1/1000.
These adverse events could be associated with the underlying disease and/or concomitant therapy.
Infections and invasions: infrequently – nasopharyngitis.
On the part of the blood system and lymphatic system: rarely – neutropenia.
Metabolism and nutrition disorders: often – increased appetite; infrequently – anorexia, hypoglycemia.
Mental disorders: often – euphoria, confusion, decreased / increased libido, irritability, increased insomnia / insomnia, disorientation; infrequently – depersonalization, anorgasmia, anxiety, depression, agitation, mood lability, depressed mood, difficulty in choosing words, hallucinations, unusual dreams, panic attacks, apathy; rarely – disinhibition, high spirits.
Neurological disorders: very often – dizziness, drowsiness; often – ataxia, impaired attention, impaired coordination, memory impairment, tremor, dysarthria, paresthesia, imbalance, amnesia, sedation, lethargy; infrequently – cognitive disorders, hypesthesia, nystagmus, speech disorder, myoclonic convulsions, weakening of reflexes, dyskinesia, psychomotor agitation, postural dizziness, hyperesthesia, loss of taste, burning sensation on the mucous membranes and skin, intentional tremor, stupor, stupor, burning sensation on the mucous membranes and skin, intensity tremor, stupor, stupor, burning sensation on the mucous membranes and skin, intentional tremor, stupor, stupor rarely – hypokinesia, parosmia, dysgraphia.
On the part of the organ of vision: often – blurred vision, diplopia; infrequently – narrowing of visual fields, reduced visual acuity, pain in the eyes, asthenopia, as well as dry eyes, puffiness of the eyes, increased lacrimation; seldom – flashes of sparks before eyes, eye irritation, mydriasis, oscillopsia (subjective sensation of vibration of the objects in question), disturbed perception of visual depth, loss of peripheral vision, strabismus, increased brightness of visual perception.
On the part of the organ of hearing and vestibular apparatus: often – vertigo; infrequently – hyperacusis.
On the part of the cardiovascular system: infrequently – tachycardia, AV block I degree, flushing of the face, lowering blood pressure, cooling the limbs, increasing blood pressure, skin flushing; rarely – sinus tachycardia, sinus arrhythmia, sinus bradycardia.
On the part of the respiratory system: infrequently – shortness of breath, cough, dry nasal mucosa; seldom – nasal congestion, nosebleed, rhinitis, snoring, feeling of tightness in the throat.
On the part of the digestive system: often – dry mouth, constipation, vomiting, flatulence, bloating; infrequently – increased salivation, gastroesophageal reflux, hypoesthesia of the oral mucosa; rarely – ascites, dysphagia, pancreatitis.
On the part of the skin: infrequently – sweating, papular rash; rarely – cold sweat, hives.
On the part of the musculoskeletal system: infrequently – muscle twitching, joint swelling, muscle spasms, myalgia, arthralgia, back pain, pain in the extremities, stiffness in the muscles; rarely – spasm of the neck muscles, pain in the neck, rhabdomyolysis.
From the urinary system: infrequently – dysuria, urinary incontinence; rarely – oliguria, renal failure.
Reproductive system: often – erectile dysfunction; infrequently – delayed ejaculation, sexual dysfunction; rarely – amenorrhea, pain in the mammary glands, discharge from the mammary glands, dysmenorrhea, enlargement of the mammary glands.
Other: often – fatigue, edema, incl. peripheral, feeling of intoxication, gait disturbance; infrequently – asthenia, falls, thirst, chest tightness, generalized edema, chills, pain, pathological sensations; rarely – hyperthermia.
Laboratory indicators and instrumental data: often – an increase in body weight; infrequently – an increase in the activity of ALT, CPK, AST, a decrease in the number of platelets; rarely, an increase in the concentration of glucose and creatinine in the blood, a decrease in the concentration of potassium in the blood, a decrease in body weight, a decrease in the number of leukocytes in the blood.
Effects noted during post-marketing observation (frequency unknown):
- Neurological disorders: headache, loss of consciousness, cognitive impairment, convulsions.
- On the part of the digestive system: rare cases of tongue edema, nausea, diarrhea.
- On the part of the skin: rare cases of swelling of the face, itching, Stevens-Johnson syndrome.
- On the part of the organ of vision: keratitis, loss of vision.
- On the part of the immune system: angioedema, allergic reactions, hypersensitivity.
- From the CCC: CHF, prolongation of the QT interval.
- On the part of the urinary system: urinary retention.
- On the part of the respiratory system: pulmonary edema.
- Reproductive system: gynecomastia.
- Other: increased fatigue.
Pregabalin is excreted in the urine, mostly unchanged, undergoes minimal human metabolism (less than 2% of the dose is excreted as metabolites in the urine), does not inhibit the metabolism of other drugs in vitro and does not bind to plasma proteins, therefore, it is unlikely to enter in pharmacokinetic interaction.
No evidence of clinically significant pharmacokinetic interaction of pregabalin with phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone, or ethanol was detected. It has been established that oral hypoglycemic drugs, diuretics, insulin, phenobarbital, tiagabine and topiramate do not have a clinically significant effect on the clearance of pregabalin.
When oral contraceptives containing norethisterone and / or ethinyl estradiol were used, the equilibrium pharmacokinetics of the drugs did not change simultaneously with pregabalin.
Reported cases of respiratory failure and the onset of coma while the use of pregabalin with other drugs, oppressive central nervous system. It was also reported on the negative impact of pregabalin on the activity of the gastrointestinal tract (including the development of intestinal obstruction, paralytic ileus, constipation), while being used with drugs that cause constipation (such as non-narcotic analgesics).
Repeated oral administration of pregabalin with oxycodone, lorazepam or ethanol did not have a clinically significant effect on respiration. Pregabalin, apparently, enhances the impairment of cognitive and motor functions caused by oxycodone. Pregabalin can enhance the effects of ethanol and lorazepam.