Note: This document contains side effect information about venlafaxine. Some dosage forms listed on this page may not apply to the brand name Effexor XR.
Summary
Common side effects of Effexor XR include: anorgasmia, asthenia, constipation, dizziness, drowsiness, headache, insomnia, nausea, nervousness, anorexia, decreased appetite, delayed ejaculation, diaphoresis, and xerostomia. Other side effects include: abdominal pain, blurred vision, hypertension, impotence, tremor, vasodilation, visual disturbance, anxiety, diarrhea, increased serum cholesterol, vomiting, weight loss, decreased libido, abnormal dreams, increased dream activity, and yawning. Continue reading for a comprehensive list of adverse effects.
Applies to venlafaxine: oral extended-release capsules and conventional tablets.
Warning
-
Suicidality
- Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.b c d Venlafaxine is not approved for use in pediatric patients.1 3 (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.c d
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.c d e
- Appropriately monitor and closely observe all patients who are started on venlafaxine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.b c d e (See Risk of Suicidality and Overdosage under Cautions.)
Side effects include:
With conventional tablets: anorexia, asthenia, constipation, dizziness, dry mouth, nausea, nervousness, somnolence, sweating.
With extended-release tablets: anorexia, asthenia, constipation, decreased sexual function (e.g., abnormal ejaculation, orgasmic dysfunction, impotence in men, decreased libido), dizziness, dry mouth, headache, insomnia, abnormal dreams, nervousness, tremor, nausea, vomiting, somnolence, sweating, abnormal vision.
For Healthcare Professionals
Applies to venlafaxine: oral capsule extended release, oral tablet, oral tablet extended release.
General
The most commonly reported side effects were nausea, headache, somnolence, and dizziness.[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 58%), dry mouth (up to 22%), constipation (up to 15%)
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, eructation, flatulence, vomiting
Uncommon (0.1% to 1%): Circumoral paresthesia, colitis, dysphagia, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, gastrointestinal ulcer, gingivitis, glossitis, hemorrhoids, melena, mouth ulceration, oral moniliasis, rectal hemorrhage, stomatitis, tongue edema
Rare (less than 0.1%): Abdominal distention, buccoglossal syndrome, cheilitis, cholecystitis, cholelithiasis, duodenitis, esophageal spasm, gastroesophageal reflux disease, gum hemorrhage, hematemesis, hyperchlorhydria, ileitis, increased salivation, intestinal obstruction, pancreatitis, parotitis, periodontitis, proctitis, salivary gland enlargement, soft stools, tongue discoloration[Ref]
Nervous system
Very common (10% or more): Headache (up to 38%), somnolence (up to 26.1%), dizziness (up to 23.9%), tremor (up to 10.2%)
Common (1% to 10%): Akathisia, amnesia, dysgeusia, hypertonia, hypesthesia, increased muscle tone, migraine, paresthesia, sedation, taste perversion, vertigo
Uncommon (0.1% to 1%): Abnormal coordination, abnormal speech, ataxia, balance disorder, central nervous system (CNS) stimulation, dyskinesia, hyperesthesia, hyperkinesia, hypotonia, incoordination, myoclonus, neuralgia, neuropathy, parosmia, seizure, syncope, stupor, taste loss, visual field defect
Rare (0.1% to 0.01%): Abnormal gait, akinesia, aphasia, bradykinesia, cerebral ischemia, cerebrovascular accident, convulsion, dementia, dystonia, facial paralysis, Guillain-Barre Syndrome, hypokinesia, loss of consciousness, neuritis, neuroleptic malignant syndrome (NMS), nystagmus, paresis, reflexes decreased, reflexes increased, serotonin syndrome, torticollis
Very rare (less than 0.01%): Extrapyramidal reactions, tardive dyskinesia
Frequency not reported: Impaired coordination, sensory disturbance
Postmarketing reports: Coordination abnormal, impaired balance, involuntary movements, NMS-like reactions, shock-like electrical sensations[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 24%), nervousness (up to 21.3%), abnormal orgasm (up to 12.5%), anxiety (up to 11.2%)
Common (1% to 10%): Abnormal dreams, abnormal thinking, agitation, anorgasmia, confusion, depersonalization, depression, libido decreased, orgasm disturbance, orgasmic dysfunction
Uncommon (0.1% to 1%): Apathy, bruxism, derealization, emotional lability, euphoria, hallucination, hostility, hypomania, libido increased, mania, manic reaction, psychosis, suicidal ideation, suicide attempt, withdrawal syndrome
Rare (less than 0.1%): Alcohol abuse, delirium, delusions, homicidal ideation, hysteria, impulse control difficulties, paranoid reaction, psychotic depression, psychomotor restlessness
Frequency not reported: Aggression, delayed orgasm, increased dreaming, intense dreams, nightmares, other sleep disorders, self-harm, sleep disturbances, suicidal behaviors, vivid dreams, withdrawal symptoms
Postmarketing reports: Catatonia, confusional state, panic, paranoia, psychotic disorder[Ref]
Dermatologic
Very common (10% or more): Sweating (up to 19.3%), night sweats (up to 11.4%)
Common (1% to 10%): Ecchymosis, hyperhidrosis, pruritus, rash
Uncommon (0.1% to 1%): Acne, alopecia, brittle nails, contact dermatitis, dry skin, eczema, face edema, maculopapular rash, photosensitivity reaction, psoriasis, skin hypertrophy, urticaria
Rare (less than 0.1%): Cellulitis, erythema multiforme, erythema nodosum, exfoliative dermatitis, furunculosis, granuloma, hair discoloration, hirsutism, leukoderma, lichenoid dermatitis, miliaria, mucocutaneous hemorrhage, petechial rash, pruritic rash, purpura, pustular rash, seborrhea, skin atrophy, skin discoloration, skin striae, Stevens-Johnson syndrome, sweating decreased, toxic epidermal necrolysis, vesiculobullous rash[Ref]
Metabolic
Very common (10% or more): Anorexia (up to 20%)
Common (1% to 10%): Blood cholesterol increased, decreased appetite, increased appetite, weight gain, weight loss
Uncommon (0.1% to 1%): Dehydration, hyperglycemia, hyperlipemia, hyperlipidemia, hypokalemia, hyponatremia, increased alkaline phosphatase, thirst
Rare (less than 0.1%): Alcohol intolerance, diabetes mellitus, gout, hemochromatosis, hypercholesteremia, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hypoglycemia, hypophosphatemia, hypoproteinemia
Frequency not reported: Height changes, loss of appetite, weight changes
Postmarketing reports: Lactate dehydrogenase (LDH) increased[Ref]
Other
Very common (10% or more): Asthenia (up to 19%)
Common (1% to 10%): Accidental injury, chills, fatigue, fever, tinnitus, trauma
Uncommon (0.1% to 1%): Hyperacusis, intentional injury, malaise, otitis media
Rare (less than 0.1%): Abortion, deafness, energy increased, feeling drunk, healing abnormal, labyrinthitis, menopause, motion sickness, otitis externa
Frequency not reported: Discontinuation syndrome, pain
Postmarketing reports: Congenital anomalies[Ref]
Genitourinary
Very common (10% or more): Abnormal ejaculation (up to 16%)
Common (1% to 10%): Albuminuria, enlarged prostate, erectile dysfunction, impotence, metrorrhagia, pollakiuria, prostatic disorder, prostatitis, urinary frequency, urinary hesitation, urinary retention, urination impaired, vaginitis
Uncommon (0.1% to 1%): Amenorrhea, bladder pain, breast pain, cystitis, dysuria, hematuria, leukorrhea, menorrhagia, nocturia, pelvic pain, polyuria, prostate irritability, pyuria, urinary incontinence, urinary urgency, vaginal hemorrhage
Rare (less than 0.1%): Balanitis, breast discharge, breast engorgement, breast enlargement, calcium crystalluria, cervicitis, endometriosis, galactorrhea, hypercalcinuria, hypomenorrhea, lactation (female), mastitis, menstrual disorders associated with increased bleeding or increased irregular bleeding, ovarian cyst, orchitis, prolonged erection, salpingitis, urolithiasis, uterine hemorrhage, uterine spasm, vaginal dryness
Frequency not reported: Delayed ejaculation, dysmenorrhea
Postmarketing reports: Proteinuria[Ref]
Cardiovascular
Common (1% to 10%): Chest pain, edema, hot flashes/hot flush, hypertension/increased blood pressure, palpitation, postural hypotension, substernal chest pain, tachycardia, vasodilation
Uncommon (0.1% to 1%): Angina pectoris, arrhythmia, bradycardia, cold feet, cold hands, extrasystoles, hypotension, orthostatic hypotension, peripheral vascular disorder, thrombophlebitis
Rare (less than 0.1%): Aortic aneurysm, arteritis, bigeminy, bundle branch block, capillary fragility, cardiovascular disorder (mitral valve and circulatory disturbance), coronary artery disease, congestive heart failure, cyanosis, ECG QT prolonged, first-degree atrioventricular block, heart arrest, hematoma, myocardial infarct, pallor, sinus arrhythmia, torsade de pointes, ventricular fibrillation, ventricular tachycardia
Postmarketing reports: Atrial fibrillation, deep vein thrombophlebitis, ECG abnormalities, stress cardiomyopathy, supraventricular tachycardia, Takotsubo cardiomyopathy, ventricular extrasystole[Ref]
Respiratory
Common (1% to 10%): Bronchitis, cough increased, dyspnea, pharyngitis, sinusitis, yawn/yawning
Uncommon (0.1% to 1%): Asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration
Rare (less than 0.1%): Atelectasis, hemoptysis, hypoventilation, hypoxia, interstitial lung disease, larynx edema, pleurisy, pulmonary embolus, pulmonary eosinophilia, sleep apnea
Frequency not reported: Rhinitis, upper respiratory infection, upper respiratory tract infection[Ref]
Ocular
Common (1% to 10%): Abnormality of accommodation, abnormal vision, blurred vision, mydriasis
Uncommon (0.1% to 1%): Cataract, conjunctivitis, corneal lesion, diplopia, dry eyes, eye pain, photophobia
Rare (less than 0.1%): Angle-closure glaucoma, blepharitis, chromatopsia, conjunctival edema, decreased pupillary reflex, exophthalmos, eye hemorrhage, keratitis, miosis, papilledema, retinal hemorrhage, scleritis, subconjunctival hemorrhage, uveitis
Frequency not reported: Difficulty focusing eyes[Ref]
Musculoskeletal
Common (1% to 10%): Neck pain, trismus, twitching
Uncommon (0.1% to 1%): arthritis, arthrosis, bone pain, bone spurs, bursitis, leg cramps, myasthenia, neck rigidity, tenosynovitis
Rare (less than 0.1%): Muscle cramp, muscle spasms, musculoskeletal stiffness, myopathy, osteoporosis, osteosclerosis, pathological fracture, plantar fasciitis, rhabdomyolysis, rheumatoid arthritis, tendon rupture
Frequency not reported: Arthralgia, back pain, myalgia
Postmarketing reports: Bone fracture, creatine phosphokinase (CPK) increased[Ref]
Immunologic
Common (1% to 10%): Flu syndrome, infection
Uncommon (0.1% to 1%): Moniliasis
Rare (less than 0.1%): Appendicitis, bacteremia[Ref]
Hematologic
Uncommon (0.1% to 1%): Anemia, leukocytosis, leukopenia, lymphadenopathy, mucous membrane bleeding, mucosal hemorrhage, thrombocythemia, thrombocytopenia
Rare (less than 0.1%): Agranulocytosis, aplastic anemia, basophilia, blood dyscrasias, eosinophilia, lymphocytosis, neutropenia, pancytopenia, prolonged bleeding time
Postmarketing reports: INR increased, prolonged partial thromboplastin time, prothrombin time increased[Ref]
Hepatic
Uncommon (0.1% to 1%): Abnormal liver function tests, ALT increased, AST increased
Rare (less than 0.1%): Biliary pain, bilirubinemia, cholecystitis, cholelithiasis, hepatitis, jaundice, liver tenderness
Postmarketing reports: Fatty liver, GGT elevation, hepatic reactions, liver damage, liver failure, liver necrosis[Ref]
Renal
Uncommon (0.1% to 1%): Kidney calculus, kidney pain
Rare (less than 0.1%): Anuria, blood urea nitrogen (BUN) increased, creatinine increased, glycosuria, kidney function abnormal, oliguria, pyelonephritis, uremia
Postmarketing reports: Renal failure[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Angioedema
Rare (less than 0.1%): Anaphylactic reaction, anaphylaxis
Frequency not reported: Hypersensitivity[Ref]
Endocrine
Rare (0.1% to 0.01%): Goiter, gynecomastia (male), hyperthyroidism, hypothyroidism, inappropriate antidiuretic hormone secretion (SIADH)/syndrome of inappropriate antidiuretic hormone secretion, thyroid nodule, thyroiditis
Very rare (less than 0.01%): Blood prolactin increased[Ref]
Oncologic
Rare (less than 0.1%): Carcinoma, fibrocystic breast, multiple myeloma[Ref]