According to the experience of clinical use of pregabalin in more than 12 000 patients, the most common adverse events were dizziness and drowsiness. The observed phenomena were usually mild or moderate. The main undesirable effects that required cessation of treatment were dizziness (4%) and drowsiness (3%), depending on their subjective tolerance. Other side effects that also lead to drug cancellation: ataxia, confusion, asthenia, impaired attention, blurred vision, impaired coordination, peripheral edema.
The "cancellation" syndrome
There are reports of cases of development of dependence when using pregabalin. As a result of cancellation of pregabalin after prolonged or short-term therapy, the following undesirable phenomena were observed: insomnia, headache, nausea, diarrhea, flu-like syndrome, depression, sweating, dizziness, convulsions and anxiety. Information on the frequency and severity of manifestations of the syndrome of "cancellation" of pregabalin, depending on the duration of therapy last and its dose is not available.
Classification by WHO (World Health Organization) of the incidence of adverse events identified as a result of clinical trials and post-marketing surveillance: often from ≥1 / 100 to <1/10 of prescriptions (≥1% and <10%); infrequently - from ≥1 / 1000 to <1/100 of prescriptions (≥0.1% and <1%); rarely from ≥1 / 10,000 to <1/1000 appointments (≥0.01% and <0.1%); very rarely - <1/10000 prescriptions (0.01%);
Infections and infestations: infrequently - nasopharyngitis.
From the side of the blood and lymphatic system: infrequently - thrombocytopenia; rarely - Neutropenia, leukopenia.
From the heart: infrequently - a tachycardia, an atrioventricular blockade of I degree; rarely - sinus tachycardia, sinus arrhythmia, sinus bradycardia; frequency unknown - chronic heart failure, prolongation of QT interval.
From the side of the vessels: infrequently - "hot flashes", lowering blood pressure, increasing blood pressure, skin hyperemia; rarely - cold extremities.
From the nervous system: very often - dizziness, drowsiness; often - ataxia, impaired attention, impaired coordination, memory impairment, tremor, dysarthria, paresthesia, imbalance, sedation, lethargy, headache; infrequently - cognitive disorders, hypoesthesia, nystagmus, speech disorders, myoclonic cramps, weakened reflexes, dyskinesia, postural dizziness, hypersthesia, amnesia, loss of taste sensations, burning sensation on the mucous membranes and skin, intentional tremor, stupor, fainting, psychomotor agitation; rarely - hypokinesia, parosmia, dysgraphy; frequency unknown - loss of consciousness, cognitive impairment, convulsions.
From the side of the psyche: often - euphoria, confusion, decreased libido, insomnia, irritability, disorientation; infrequently - depersonalization, anorgasmia, anxiety, depression, agitation, lability of mood, depressed mood, difficulty in word selection, hallucinations, unusual dreams, increased libido,panic attacks, apathy; rarely - disinhibition, high spirits; frequency is unknown - aggression.
From the side of the organ of vision: often - blurred vision, diplopia; infrequent - visual impairment: narrowing of the visual fields, reduced visual acuity, eye pain, asthenopia, dry eyes, puffiness of the eyes, increased lacrimation; rarely - flashes of sparks before the eyes, eye irritation, mydriasis, oscilloscopy (subjective sensation of fluctuations in the subjects under consideration), impaired perception of visual depth, loss of peripheral vision, strabismus, increased brightness of visual perception; frequency unknown - keratitis, loss of vision.
From the side of the hearing organ and labyrinthine disorders: often - Vertigo; infrequently - Hyperacusis.
From the digestive system: often - dry mouth, constipation, vomiting, flatulence; infrequent - bloating, increased salivation, gastroesophageal reflux, hypoesthesia of the oral mucosa; rarely - ascites, dysphagia, pancreatitis, tongue edema, nausea, diarrhea.
On the part of the respiratory system, the organs of the thorax and the mediastinum: infrequently - shortness of breath, dryness of the nasal mucosa; rarely - stuffy nose, nosebleed, cough, rhinitis, snoring, a feeling of "restraint" in the throat; frequency unknown - pulmonary edema.
From the musculoskeletal and connective tissues: infrequent - twitching of muscles, swelling of the joints, muscle spasms, myalgia, arthralgia, back pain, pain in the limbs, stiffness of the muscles; rarely - spasm of the neck muscles, neck pain, rhabdomyolysis.
From the side of metabolism and nutrition: often - increased appetite, weight gain; infrequently - anorexia, hypoglycemia; rarely - weight loss.
From the urinary system: infrequently - dysuria, incontinence; rarely - oliguria, renal insufficiency; frequency unknown - retention of urine.
On the part of reproductive function: often - erectile disfunction; infrequently - delay of ejaculation, sexual dysfunction; rarely - amenorrhea, pain in the mammary glands, discharge from the mammary glands, dysmenorrhea, enlargement of mammary glands in the volume; frequency unknown - gynecomastia.
From the immune system: frequency unknown - angioedema, allergic reactions, hypersensitivity.
From the skin: infrequently sweating, papular rash; rarely cold sweating, hives; frequency unknown - edema of the face, itching, Stevens-Johnson syndrome.
Laboratory and instrumental data: infrequently - increased activity of alanine aminotransferase, creatine phosphokinase, aspartate aminotransferase; rarely - an increase in the concentrations of glucose and creatinine of the blood, a decrease in the concentration of potassium blood.
Other: often - fatigue, swelling, including peripheral, feeling of "intoxication", violation of gait; infrequently - asthenia, falls, thirst, a feeling of restraint in the chest, pain, pathological sensations, chills; rarely - generalized edema, hyperthermia.