Note: This document contains side effect information about paroxetine. Some dosage forms listed on this page may not apply to the brand name Brisdelle.
Summary
Common side effects of Brisdelle include: asthenia, constipation, diarrhea, dizziness, drowsiness, ejaculatory disorder, erectile dysfunction, insomnia, male genital disease, nausea, headache, decreased libido, delayed ejaculation, diaphoresis, and xerostomia. Other side effects include: infection, blurred vision, female genital tract disease, impotence, lack of concentration, orgasm disturbance, tremor, vasodilation, visual disturbance, anxiety, paresthesia, abnormal dreams, decreased appetite, and yawning. Continue reading for a comprehensive list of adverse effects.
Applies to paroxetine: oral conventional tablets, oral extended-release tablets, oral suspension.
Warning
-
Suicidality
- Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo 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.314 315 611 Paroxetine is not approved for use in pediatric patients.611 (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and was reduced in adults ≥65 years of age with antidepressants compared with placebo.314 315 611
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.314 315 320 611
- Appropriately monitor and closely observe all patients who are started on paroxetine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.314 315 320 611 (See Worsening of Depression and Suicidality Risk under Cautions.)
Side effects include:
Nervous system effects (e.g., asthenia, somnolence, dizziness, insomnia, tremor, nervousness), GI effects (e.g., nausea, decreased appetite, constipation, dry mouth), impotence, ejaculatory dysfunction, female genital disorders (e.g., anorgasmia or difficulty reaching climax/orgasm), sweating.
For Healthcare Professionals
Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release.
General
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS: The most commonly reported side effects included nausea, ejaculation disturbance/abnormal ejaculation, somnolence, and asthenia.
HYDROCHLORIDE CR FORMULATIONS: The most commonly reported side effects included headache, ejaculation disturbance, nausea, and somnolence.
MESYLATE CAPSULES: The most commonly reported side effects included headache, fatigue, lethargy, and malaise.[Ref]
Gastrointestinal
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Nausea (up to 36.3%), dry mouth (up to 20.6%), diarrhea (up to 19.2%), constipation (up to 16%)
Common (1% to 10%): Abdominal pain, dyspepsia, gastrointestinal disorder, flatulence, stomatitis, tooth disorder, vomiting
Uncommon (0.1% to 1%): Buccal cavity disorders, colitis, dysphagia, eructation, gastritis, gastroenteritis, gastrointestinal flu, gingivitis, glossitis, increased salivation, rectal hemorrhage, ulcerative stomatitis
Rare (0.01% to 0.1%): Aphthous stomatitis, bloody diarrhea, cardiospasm, circumoral paresthesias, duodenitis, enteritis, esophagitis, fecal impactions, fecal incontinence, gum hemorrhage, hematemesis, ileitis, ileus, intestinal obstruction, melena, mouth ulceration, peptic ulcer, salivary gland enlargement, sialadenitis, stomach ulcer, stomatitis, tongue discoloration, tongue edema, tooth caries
Very rare (less than 0.01%): Gastrointestinal bleeding
Postmarketing reports: Acute pancreatitis
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Nausea (up to 23%), diarrhea (up to 18%), dry mouth (up to 18%), constipation (up to 13%), dyspepsia (up to 13%)
Common (1% to 10%): Abdominal pain, flatulence
Frequency not reported: Vomiting
Postmarketing reports: Acute pancreatitis
MESYLATE CAPSULES:
Common (1% to 10%): Nausea, vomiting
Uncommon (0.1% to 1%): Abdominal pain
Postmarketing reports: Pancreatitis, pancreatitis hemorrhage[Ref]
Nervous system
Extrapyramidal symptoms such as akathisia, bradykinesia, cogwheel rigidity, dystonia, hypertonia, and oculogyric crisis have been associated with concomitant pimozide therapy.
Potentially life-threatening serotonin syndrome has been reported with SSRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin. Signs and symptoms associated with serotonin syndrome or neuroleptic malignant syndrome included agitation, confusion, diaphoresis, diarrhea, fever, hypertension, rigidity, and tachycardia, and were in some cases associated with concomitant use of serotonergic drugs.[Ref]
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Somnolence (up to 24%), headache (up to 18%), tremor (up to 14.7%), dizziness (up to 14%)
Common (1% to 10%): Amnesia, central nervous system (CNS) stimulation, drugged feeling, hyperesthesia, impaired concentration, myoclonus, paresthesia, sensory disturbance, syncope, taste perversion, vertigo
Uncommon (0.1% to 1%): Ataxia, convulsion, dystonia, dyskinesia, extrapyramidal disorders, hyperkinesia, hypertonia, hypesthesia, hypokinesia, incoordination, migraine, paralysis
Rare (0.01% to 0.1%): Abnormal electroencephalogram, abnormal gait, adrenergic syndrome, akathisia, akinesia, aphasia, cerebral ischemia, cerebrovascular accident, choreoathetosis, decreased reflexes, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsion, hyperalgesia, increased reflexes, meningitis, myelitis, neuralgia, neuropathy, nystagmus, parosmia, peripheral neuritis, restless legs syndrome (RLS), stupor, taste loss, vascular headache, visual field defect
Very rare (less than 0.01%): Serotonin syndrome
Frequency not reported: Electric shock sensation, hyperreflexia, orofacial dystonia
Postmarketing reports: Bradykinesia, cogwheel rigidity, extrapyramidal symptoms, Guillain-Barre syndrome, optic neuritis, status epilepticus
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Headache (up to 27%), somnolence (up to 22%), dizziness (up to 14%)
Common (1% to 10%): Concentration impaired, tremor
Uncommon (0.1% to 1%): Convulsion, akathisia
Frequency not reported: Hyperkinesia, hypertonia, migraine, myoclonus, paresthesia, seizures, serotonin syndrome, taste perversion
Postmarketing reports: Bradykinesia, cogwheel rigidity, dystonia, extrapyramidal syndrome, Guillain-Barre syndrome, hypertonia, optic neuritis, RLS, status epilepticus
MESYLATE CAPSULES:
Common (1% to 10%): Headache, lethargy
Uncommon (0.1% to 1%): Attention disturbances
Frequency not reported: Akathisia, restless feeling in legs, seizure, serotonin syndrome, tiredness, trouble sweeping
Postmarketing reports: Neuroleptic malignant syndrome, paresthesia, somnolence, tremor[Ref]
Genitourinary
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Ejaculation disturbance (up to 28%), abnormal ejaculation (up to 25%), other male genital disorders (up to 10%)
Common (1% to 10%): Female genital disorder, impotence, sexual dysfunction, urinary frequency, urinary tract infection (UTI), urination impaired
Uncommon (0.1% to 1%): Abnormal gynecological bleeding, amenorrhea, breast pain, cystitis, dysuria, hematuria, menorrhagia, nocturia, polyuria, pyuria, urinary incontinence, urinary retention, urinary urgency, vaginitis
Rare (0.01% to 0.1%): Breast atrophy, breast enlargement, delayed menstruation, endometrial disorder, epididymitis, female lactation, fibrocystic breast, irregular menstruation, leukorrhea, mastitis, metrorrhagia, pelvic pain, salpingitis, urethritis, uterine spasm, urolith, vaginal hemorrhage, vaginal moniliasis
Frequency not reported: Delayed ejaculation, dysmenorrhea, erectile difficulties, micturition difficulty, sexual dysfunction, urinary hesitancy, vaginal bleeding
Postmarketing reports: Galactorrhea, menstrual disorders, priapism
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Ejaculation disturbance (up to 27%)
Common (1% to 10%): Female genital disorder, impotence
Uncommon (0.1% to 1%): Urinary retention
Rare (0.01% to 0.1%): Urinary incontinence
Frequency not reported: Delayed ejaculation, impaired urination, menstrual disorder, priapism, untoward sexual experience/performance, urinary disorder, urinary frequency, UTI, vaginitis
Postmarketing reports: Galactorrhea[Ref]
There are several reports of priapism associated with use.[Ref]
Psychiatric
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Insomnia (up to 24%), decreased libido (up to 15%)
Common (1% to 10%): Abnormal dreams, agitation, anxiety, confusion, depersonalization, depression, emotional lability, nervousness, nightmares, orgasmic disturbance, sleep disturbance
Uncommon (0.1% to 1%): Abnormal thinking, alcohol abuse, bruxism, euphoria, hallucinations, hostility, increased libido, lack of emotion, manic reaction, neurosis, paranoid reaction
Rare (0.01% to 0.1%): Antisocial reaction, bulimia, delirium, delusions, drug dependence, hysteria, manic-depressive reaction, panic attacks, psychotic depression, psychosis, withdrawal syndrome
Frequency not reported: Aggression, anorgasmia, delayed orgasm, difficulty reaching climax/orgasm, intense dreams, mood fluctuations, self-harm, suicidal behavior, suicidal ideation/thoughts, suicide attempts
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Insomnia (up to 20%), decreased libido (up to 13%)
Common (1% to 10%): Anxiety, depression, nervousness, orgasmic disturbance
Uncommon (0.1% to 1%): Hallucinations, manic reaction
Frequency not reported: Agitation, anorgasmia, confusion, delayed orgasm, difficulty achieving orgasm, hypomania activation, mania activation, suicidal behaviors, suicidal thoughts
MESYLATE CAPSULES:
Uncommon (0.1% to 1%): Suicidal ideation
Frequency not reported: Anxiety, hypomania, increased dreaming, insomnia, mania, nervousness, nightmares, suicidality, suicide attempt
Postmarketing reports: Aggression, agitation, confusional state, depression, disorientation, drug withdrawal syndrome, homicidal ideation, restlessness[Ref]
Other
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Asthenia (up to 22%)
Common (1% to 10%): Chills, fever, malaise, pain, tinnitus, trauma
Uncommon (0.1% to 1%): Ear pain, otitis media, overdose
Rare (0.01% to 0.1%): Abnormal laboratory value, abortion, chills and fever, cyst, deafness, hernia, hyperacusis, intentional overdose, otitis externa, ulcer
Frequency not reported: Crying, lump in throat
Postmarketing reports: Eclampsia, elevated phenytoin level, premature birth
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Asthenia (up to 18%)
Frequency not reported: Discontinuation syndrome, embryofetal toxicity, neonatal toxicity
Postmarketing reports: Eclampsia
MESYLATE CAPSULES:
Common (1% to 10%): Fatigue, malaise
Postmarketing reports: Death[Ref]
Dermatologic
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Very common (10% or more): Sweating/diaphoresis (up to 14%)
Common (1% to 10%): Pruritus, rash/skin rash
Uncommon (0.1% to 1%): Abnormal skin bleeding, acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, face edema, herpes simplex, photosensitivity, purpura, urticaria
Rare (0.01% to 0.1%): Decreased sweating, erythema nodosum, erythema multiforme, exfoliative dermatitis, fungal dermatitis, furunculosis, hirsutism, maculopapular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, vesicobullous rash
Very rare (less than 0.01%): Severe cutaneous adverse reactions, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)
Postmarketing reports: Henoch-Schonlein purpura
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Sweating (up to 14%)
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Erythema multiforme
Frequency not reported: Eczema, photosensitivity
Postmarketing reports: Henoch-Schonlein purpura, SJS, TEN
MESYLATE CAPSULES:
Postmarketing reports: Hyperhidrosis, SJS, TEN[Ref]
Metabolic
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Common (1% to 10%): Decreased appetite, increased appetite, increased cholesterol levels, weight gain, weight loss
Uncommon (0.1% to 1%): Altered glycemic control, hyperglycemia, obesity, thirst
Rare (0.01% to 0.1%): Dehydration, diabetes mellitus, hypercalcemia, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, ketosis, lactic dehydrogenase increased, tetany
Postmarketing reports: Porphyria
HYDROCHLORIDE CR FORMULATIONS:
Very common (10% or more): Decreased appetite (up to 12%)
Uncommon (0.1% to 1%): Hypercholesterolemia
Frequency not reported: Hyponatremia, weight gain, weight loss
Postmarketing reports: Porphyria
MESYLATE CAPSULES:
Frequency not reported: Hyponatremia
Postmarketing reports: Diabetes mellitus inadequate control, type 2 diabetes mellitus[Ref]
Cardiovascular
HYDROCHLORIDE IMMEDIATE-RELEASE (IR)/MESYLATE TABLET FORMULATIONS:
FORMULATIONS:
Common (1% to 10%): Chest pain, hypertension, palpitation, postural hypotension, sinus tachycardia/tachycardia, vasodilation
Uncommon (0.1% to 1%): Abnormal ECG, abnormal mucous membrane bleeding, bradycardia, edema, hematoma, hypotension, peripheral edema, transient decreases/increases in blood pressure
Rare (0.01% to 0.1%): Angina pectoris, arrhythmia/arrhythmia nodal, atrial arrhythmia, atrial fibrillation, bundle branch block, conduction abnormalities, congestive heart failure, extrasystoles, heart block, low cardiac output, lymphedema, myocardial infarction, myocardial ischemia, pallor, phlebitis, substernal chest pain, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, ventricular extrasystoles
Postmarketing reports: Severe hypotension, torsade de pointes, vasculitic syndrome, ventricular fibrillation, ventricular tachycardia
HYDROCHLORIDE CONTROLLED-RELEASE (CR) FORMULATIONS:
Uncommon (0.1% to 1%): Postural hypotension, generalized edema
Frequency not reported: Tachycardia, hypertension, vasodilation
Postmarketing reports: Torsade de pointes, vasculitic syndromes, ventricular fibrillation, ventricular tachycardia
MESYLATE CAPSULES:
Postmarketing reports: Atrial fibrillation, ventricular fibrillation, ventricular tachycardia, torsade de pointes[Ref]
Respiratory
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Common (1% to 10%): Oropharynx disorder, respiratory disorder, rhinitis, sinusitis, yawn
Uncommon (0.1% to 1%): Asthma, bronchitis, dyspnea, epistaxis, hyperventilation, pneumonia, respiratory flu
Rare (0.01% to 0.1%): Emphysema, hemoptysis, hiccups, increased sputum, lung fibrosis, pulmonary edema, pulmonary embolus, stridor, voice alteration
Frequency not reported: Cough increased, pharyngitis, throat tightness, upper respiratory infection (URI)
Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension
HYDROCHLORIDE CR FORMULATIONS:
Common (1% to 10%): Sinusitis, yawn
Frequency not reported: Bronchitis, increased cough, rhinitis
Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension
MESYLATE CAPSULES:
Postmarketing reports: Pulmonary edema, pulmonary hypertension[Ref]
Musculoskeletal
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Common (1% to 10%): Arthralgia, back pain, myalgia, myasthenia, myopathy
Uncommon (0.1% to 1%): Arthritis, arthrosis, neck pain, traumatic fracture
Rare (0.01% to 0.1%): Bursitis, cartilage disorder, creatinine phosphokinase increased, generalized spasm, myositis, neck rigidity, osteoporosis, tenosynovitis, torticollis, trismus
Frequency not reported: Shivering
Postmarketing reports: Bone fracture
HYDROCHLORIDE CR FORMULATIONS:
Common (1% to 10%): Back pain, myalgia
Frequency not reported: Bone fracture
Postmarketing reports: Trismus
MESYLATE CAPSULES:
Frequency not reported: Bone fractures, muscle cramps/spasms/twitching[Ref]
Patients 50 years or older receiving selective serotonin reuptake inhibitors (SSRIs) have shown an increased risk of bone fractures.[Ref]
Ocular
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Common (1% to 10%): Abnormal vision, blurred vision
Uncommon (0.1% to 1%): Accommodation abnormal, conjunctivitis, eye pain, keratoconjunctivitis, mydriasis
Rare (0.01% to 0.1%): Amblyopia, anisocoria, blepharitis, cataract, conjunctival edema, corneal lesion, corneal ulcer, diplopia, exophthalmos, eye hemorrhage, glaucoma, night blindness, photophobia, ptosis, retinal hemorrhage, specified cataract
Postmarketing reports: Oculogyric crisis
HYDROCHLORIDE CR FORMULATIONS:
Common (1% to 10%): Abnormal vision
Frequency not reported: Angle-closure glaucoma
MESYLATE CAPSULES:
Frequency not reported: Angle-closure glaucoma[Ref]
Immunologic
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Candidiasis, moniliasis
Rare (0.01% to 0.1%): Abscess, cellulitis, herpes zoster, peritonitis, sepsis
Frequency not reported: Cold symptoms, flu syndrome
HYDROCHLORIDE CR FORMULATIONS:
Common (1% to 10%): Infection[Ref]
Hepatic
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Uncommon (0.1% to 1%): Abnormal liver function tests, ALT increased, AST increased
Rare (0.01% to 0.1%): Alkaline phosphatase increased, bilirubinemia, cholelithiasis, elevation of liver enzymes, gamma globulins increased, hepatitis, jaundice
Very rare (less than 0.01%): Hepatic events, liver failure
Postmarketing reports: Fatal liver necrosis, grossly elevated transaminases with severe liver dysfunction, liver necrosis
HYDROCHLORIDE CR FORMULATIONS:
Common (1% to 10%): Abnormal liver function tests
Postmarketing reports: Elevated liver function tests, fatal liver necrosis, grossly elevated transaminases associated with severe liver dysfunction, liver necrosis
MESYLATE CAPSULES:
Postmarketing reports: Drug-induced liver injury, elevated liver tests, fatal liver necrosis, grossly elevated transaminases associated with severe liver dysfunction, hepatic failure, jaundice, liver necrosis[Ref]
Hematologic
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Uncommon (0.1% to 1%): Abnormal bleeding, anemia, leukopenia, lymphadenopathy, white blood cell abnormality
Rare (0.01% to 0.1%): Abnormal erythrocytes, abnormal lymphocytes, basophilia, bleeding time increased, eosinophilia, hypochromic anemia, iron deficiency anemia, leukocytosis, lymphocytosis, microcytic anemia, monocytosis, normocytic anemia, thrombocythemia, thrombocytopenia
Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, hematopoiesis impaired, hemolytic anemia, pancytopenia
HYDROCHLORIDE CR FORMULATIONS:
Rare (0.01% to 0.1%): Thrombocytopenia
Frequency not reported: Increased bleeding risk
Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, hemolytic anemia, impaired hematopoiesis, pancytopenia
MESYLATE CAPSULES:
Frequency not reported: Abnormal bleeding
Postmarketing reports: Agranulocytosis, aplastic anemia, bone marrow aplasia, impaired hematopoiesis, idiopathic thrombocytopenic purpura, pancytopenia[Ref]
Hypersensitivity
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Uncommon (0.1% to 1%): Allergic reaction
Rare (0.01% to 0.1%): Angioedema
Very rare (less than 0.01%): Anaphylactoid reactions, fatal allergic reactions/severe allergic reactions
Postmarketing reports: Anaphylaxis
HYDROCHLORIDE CR FORMULATIONS:
Rare (0.01% to 0.1%): Angioedema
Frequency not reported: Allergic reaction, hypersensitivity reactions
Postmarketing reports: Anaphylaxis
MESYLATE CAPSULES:
Postmarketing reports: Anaphylactoid reaction, angioedema[Ref]
Renal
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Rare (0.01% to 0.1%): Blood urea nitrogen (BUN) increased, kidney calculus, kidney pain, nephritis, non-protein nitrogen (NPN) increased, oliguria, urinary casts
Postmarketing reports: Acute renal failure
HYDROCHLORIDE CR FORMULATIONS:
Postmarketing reports: Acute renal failure[Ref]
Endocrine
HYDROCHLORIDE IR/MESYLATE TABLET FORMULATIONS:
Rare (0.01% to 0.1%): goiter, Hyperprolactinemia, hyperthyroidism, hypothyroidism, thyroiditis
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone (SIADH) secretion
Postmarketing reports: Prolactinemia symptoms
HYDROCHLORIDE CR FORMULATIONS:
Postmarketing reports: Prolactinemia, SIADH secretion[Ref]
