The most common side effects in patients taking duloxetine, there was nausea, headache, dry mouth, drowsiness and dizziness. Nevertheless, most of these side effects were mild and moderate, occurred at the beginning of therapy, and subsequently their severity decreased.
Classification of WHO frequency of development of side effects:
very often - 1/10 appointments (> 10%)
often - 1/100 appointments (> 1% and <10%)
infrequently - 1/1000 appointments (> 0.1% and <1%)
rarely - 1/10000 appointments (> 0.01% and <0.1%)
very rarely - less than 1/10000 prescriptions (<0.01%)
Infectious and parasitic diseases
Infrequently: laryngitis.
Immune system disorders
Rarely: anaphylactic reaction, hypersensitivity.
Disorders from the endocrine system
Rarely: hypothyroidism.
Disorders from the metabolism and nutrition
Very often: decreased appetite15.
Infrequently: hyperglycemia (especially often observed in patients with diabetes mellitus).
Rarely: dehydration, hyponatremia, syndrome of inadequate secretion of antidiuretic hormone6.
Disorders of the psyche
Very often: insomnia11.
Often: agitation10, anxiety, unusual dreams20, decreased libido (including loss of libido), violation of orgasm (including anorgasmia).
Infrequently: suicidal thoughts5’22, sleep disorders, bruxism, disorientation19, apathy.
Rarely: suicidal behavior5,22, mania, hallucinations, aggression and hostility4.
Disturbances from the nervous system
Very often: dizziness, headache, drowsiness12.
Often: tremor, paresthesia18.
Infrequent: myoclonus, akathisia22, increased excitability, impaired concentration, lethargy, dysgeusia, dyskinesia, restless legs syndrome, decreased sleep quality.
Rarely: serotonin syndrome6, convulsions1, psychomotor agitation6, extrapyramidal disorders6.
Disturbances on the part of the organ of sight
Often: blurred vision.
Infrequently: mydriasis, impaired vision.
Rarely: glaucoma, dry eyes.
Hearing disorders and labyrinthine disorders
Often: tinnitus1.
Infrequently: vertigo, pain in the ears.
Heart Disease
Often: a feeling of palpitations.
Infrequently: tachycardia, supraventricular arrhythmia, mainly atrial fibrillation.
Vascular disorders
Often: congestion (including "hot flashes").
Infrequently: hypertension3,22, increased blood pressure3,14, cold extremities, orthostatic hypotension2, fainting2.
Rarely: hypertensive crisis3’6.
Disturbances from the respiratory system, chest and mediastinal organs
Often: yawning, pain in the oropharynx.
Infrequent: a feeling of restraint in the throat, nosebleeds.
Disorders from the gastrointestinal tract
Very often: dry mouth (12.8%), nausea (24.3%), constipation.
Often: diarrhea, vomiting, indigestion (including abdominal discomfort), flatulence, pain in the stomachthose9 .
Infrequently: gastrointestinal bleeding7, gastroenteritis, gastritis, eructation, dysphagia.
Rarely: stomatitis, odor from the mouth, hematocheia.
Disturbances from the liver and bile ducts
Infrequently: hepatitis3, acute liver damage.
Rarely: liver failure6, jaundice6.
Disturbances from the skin and subcutaneous tissues
Often: increased sweating, rash, itching.
Infrequently: night sweats, hives, contact dermatitis, cold sweat, photosensitivity, increased tendency to bruising.
Rarely: Stevens-Johnson syndrome6, angioedema6.
Very rarely: contusion of tissues.
Disturbances from musculoskeletal and connective tissue
Often: musculoskeletal pain, stiffness of muscles, muscle spasms.
Infrequently: muscle cramps.
Rarely: trismus.
Disorders from the kidneys and urinary tract
Often: increased frequency of urination.
Infrequent: urinary retention, dysuria, difficulty in starting urination, nocturia, polyuria, weakening of urine flow.
Rarely: an unusual smell of urine.
Violations of the genitals and mammary gland
Often: erectile dysfunction.
Infrequently: ejaculation disorder21, delayed ejaculation, sexual dysfunction, gynecological bleeding, menstrual irregularity, pain in the testicles.
Rarely: symptoms of menopause, galactorrhea, hyperprolactinaemia.
General disorders and disorders at the site of administration
Very common: increased fatigue13.
Often: falls8, change in taste.
Infrequent: chest pain22, atypical sensations, a feeling of hunger, thirst, chills, malaise, a feeling of heat, a violation of gait.
Laboratory and instrumental data
Often: weight loss.
Infrequently: weight gain, increased concentration of alanine aminotransferase (ALT), aspartate aminotransferase (ACT), alkaline phosphatase, gamma-glutamyltranspeptidase, bilirubin, creatine phosphokinase, pathological deviation of hepatic enzymes, increased potassium concentration in the blood.
Rarely: an increase in the concentration of cholesterol in the blood.
1Cases of seizures and noise in the ears were also noted after treatment was completed duloxetine.
2Orthostatic hypotension and syncope were noted especially at the beginning of the treatment.
3See section "Special instructions".
4Cases of aggression and hostility were noted especially at the beginning of treatment with duloxetine or after its completion.
5Cases of suicidal thoughts or suicidal behavior were noted during duloxetine therapy or in the early period after completion of treatment.
6The estimated frequency of the undesired reaction. Not observed during clinical trials.
7Also includes hemorrhagic diarrhea, bleeding from the lower sections of the gastrointestinal tract, vomiting of blood, hemorrhoidal hemorrhage, meleon, rectal bleeding, ulcer bleeding.
8Falls were more common in the elderly (≥ 65 years old).
9Including pain in the upper and lower abdomen, anterior abdominal wall tension, abdominal discomfort, gastrointestinal pain.
10Including internal trembling, motor anxiety, tension, psychomotor agitation.
11Including awakenings in the middle of the night, early morning awakening, difficulty falling asleep.
12Including hypersomnia, sedation.
13Including asthenia.