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Note: This document contains side effect information about paroxetine. Some of the dosage forms listed on this page may not apply to the brand name Brisdelle.In 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. See below for a comprehensive list of adverse effects.For the Consumer
Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended release
Oral route (Capsule)
Antidepressants, including selective serotonin reuptake inhibitors (SSRIs), have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Because paroxetine mesylate is an SSRI, monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
Oral route (Tablet)
Antidepressants have been shown to increase the risk of suicidal thoughts and behavior in pediatric and young adult patients when used to treat major depressive disorder and other psychiatric disorders. Anyone considering the use of paroxetine mesylate or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Monitor patients closely for worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.
Oral route (Tablet; Tablet, Extended Release; Suspension)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders. This risk was not observed in patients older than 24 years, and the risk was reduced in patients 65 years or older. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Paroxetine hydrochloride is not approved for use in pediatric patients.
Along with its needed effects, paroxetine (the active ingredient contained in Brisdelle) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking paroxetine:
Incidence not known
Some side effects of paroxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to paroxetine: oral capsule, oral suspension, oral tablet, oral tablet extended releaseGeneral
Side effects are generally reported as mild. The most common side effects associated with treatment discontinuation in clinical trials included somnolence, insomnia, agitation, tremor, anxiety, dizziness, headache, constipation, nausea, diarrhea, dry mouth, vomiting, flatulence, asthenia, abnormal ejaculation, sweating, impotence, and decreased libido.
The most common dose-dependent side effects associated with treatment discontinuation in clinical trials for the treatment of premenstrual dysphoric disorder with controlled-release paroxetine (the active ingredient contained in Brisdelle) 25 mg compared with 12.5 mg included nausea, somnolence, impaired concentration, dry mouth, dizziness, decreased appetite, sweating, tremor, and yawn.
The most common side effects associated with treatment discontinuation in the treatment of vasomotor symptoms in clinical trials included abdominal pain, attention disturbances, headache, and suicidal ideation.
In a placebo-controlled study in elderly patients with major depressive disorder, the most common side effects associated with treatment discontinuation of controlled-release paroxetine included nausea, headache, depression, and abnormal LFTs.
There may be adaptation to some side effects (such as nausea and dizziness) but not to others (such as dry mouth, somnolence, and asthenia) with continued therapy. Paroxetine is less likely than tricyclic antidepressants to be associated with dry mouth, constipation, and somnolence.Psychiatric
Very common (10% or more): Insomnia
Common (1% to 10%): Abnormal dreams, agitation, anxiety, depersonalization, depression, drugged feeling, emotional lability, lack of emotion, nervousness
Uncommon (0.1% to 1%): Abnormal thinking, alcohol abuse, bruxism, euphoria, hallucinations, hostility, lack of emotion, manic reaction, neurosis, paranoid reaction
Rare (less than 0.1%): Abnormal electroencephalogram, antisocial reaction, bulimia, delirium, delusions, drug dependence, hysteria, irritability, manic-depressive reaction, panic attacks, psychosis, psychotic depression, stupor, withdrawal syndrome
Frequency not reported: Suicidal ideation and behavior
Postmarketing reports: Confusional state, disorientation, homicidal ideation, restlessness
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.
Pooled results from clinical trials report hallucinations in 22 of 9089 patients who received paroxetine and 4 of 3187 patients who received placebo.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 and SNRIs 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.
Very common (10% or more): Dizziness, headache, somnolence, tremor
Common (1% to 10%): Amnesia, anxiety, CNS stimulation, confusion, hypertonia, impaired concentration, migraine, myoclonus, paresthesia, taste perversion
Uncommon (0.1% to 1%): Ataxia, convulsion, dyskinesia, dystonia, hyperesthesia, hyperkinesia, hypokinesia, incoordination, neuralgia, neuropathy, nystagmus, paralysis, syncope
Rare (less than 0.1%): Abnormal gait, adrenergic syndrome, akathisia, akinesia, anticholinergic syndrome, aphasia, cerebral ischemia, cerebrovascular accident, choreoathetosis, circumoral paresthesia, dysarthria, extrapyramidal syndrome, fasciculations, grand mal convulsions, hyperalgesia, meningitis, myelitis, peripheral neuritis, reflexes decreased, reflexes increased, taste loss, torticollis, trismus, vascular headache
Postmarketing reports: Eclampsia, Guillain-Barre syndrome, neuroleptic malignant syndrome, restless legs syndrome, serotonin syndrome, status epilepticusMetabolic
The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine (the active ingredient contained in Brisdelle) sertraline, citalopram) may cause an increase in serum total cholesterol, HDL cholesterol, and/or LDL cholesterol. However, additional studies are necessary to confirm these findings.
Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). Risk factors for the development of SSRI- associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.
Common (1% to 10%): Decreased appetite, increased appetite, increases in cholesterol levels, weight gain, weight loss
Uncommon (0.1% to 1%): Hypoglycemia, hypokalemia, thirst
Rare (less than 0.1%): Alkaline phosphatase increased, creatinine phosphokinase increased, dehydration, diabetes mellitus, gamma globulins increased, gout, hypercalcemia, hypercholesteremia, hyperglycemia, hyperkalemia, hyperphosphatemia, hypocalcemia, hyponatremia, ketosis, lactic dehydrogenase increased, non-protein nitrogen increased, obesity
Postmarketing reports: PorphyriaCardiovascular
Common (1% to 10%): Chest pain, edema, palpitation, peripheral edema, tachycardia, vasodilation (usually flushing)
Uncommon (0.1% to 1%): Abnormal electrocardiogram, angina pectoris, bradycardia, conduction abnormalities, hematoma, hypertension, hypotension, palpitation, postural hypotension, sinus tachycardia, supraventricular tachycardia
Rare (less than 0.1%): Arrhythmia, arrhythmia nodal, atrial arrhythmia, atrial fibrillation, bundle branch block, cellulitis, congestive heart failure, extrasystoles, heart block, low cardiac output, myocardial infarct, myocardial ischemia, pallor, phlebitis, substernal chest pain, supraventricular extrasystoles, thrombophlebitis, thrombosis, varicose vein, ventricular extrasystoles
Postmarketing reports: Atrial fibrillation, pulmonary edema, ventricular fibrillation, ventricular tachycardia (including torsades de pointes)Other
Fatigue, malaise, and lethargy were very commonly reported in Phase 2 and 3 clinical trials with paroxetine (the active ingredient contained in Brisdelle) for treatment of vasomotor symptoms in postmenopausal women.
Very common (10% or more): Asthenia
Common (1% to 10%): Chills, pain, tinnitus, trauma, vertigo
Uncommon (0.1% to 1%): Ear pain, fever, malaise, otitis media, overdose
Rare (less than 0.1%): Abscess, deafness, hypothermia, otitis externa, sepsis, ulcer, abnormal laboratory value, cyst, hernia, intentional overdose
Postmarketing reports: DeathGenitourinary
Very common (10% or more): Decreased libido, ejaculation disturbance, other male genital disorders (primarily ejaculatory delay)
Common (1% to 10%): Female genital disorders (primarily anorgasmia and difficulty reaching climax/orgasm), dysmenorrhea, impotence, menorrhagia, menstrual disorder, urinary disorder (primarily difficulty with micturition and urinary hesitancy), urinary frequency, urination impaired, urinary tract infection, vaginal moniliasis, vaginitis
Uncommon (0.1% to 1%): Albuminuria, amenorrhea, breast pain, cystitis, dysuria, hematuria, increased libido, nocturia, ovarian cyst, polyuria, pyuria, pregnancy and puerperal disorders, testes pain, urinary incontinence, urinary retention, urinary urgency,
Rare (0.01% to 0.1%): Abortion, breast atrophy, breast enlargement, endometrial disorder, epididymitis, female lactation, fibrocystic breast, kidney calculus, kidney pain, leukorrhea, mastitis, metrorrhagia, nephritis, oliguria, pelvic pain, salpingitis, urethritis, urinary abnormality, urinary casts, uterine spasm, urolith, vaginal hemorrhage
Very rare (less than 0.01%): Priapism
Postmarketing reports: Premature births in pregnant women, symptoms suggestive of galactorrhea
There are several reports of priapism associated with paroxetine use. In cases in which outcome was reported, all patients fully recovered.
In placebo-controlled clinical trials, ejaculatory disturbance in men was reported in 13% to 28% of men taking paroxetine, compared to 0% to 2% in the placebo group. Decreased libido was reported in 6% to 15% in men treated with paroxetine, compared to 0% to 5% in the placebo group, and in 0% to 9% in women treated with paroxetine, compared with 0% to 2% in placebo patients. The estimates of the incidence of untoward sexual experience and performance may underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue.Dermatologic
Seven cases of alopecia have been reported. In all cases, hair loss was eventually reversible.
A case of cutaneous leukocytoclastic vasculitis has been reported following treatment with paroxetine (the active ingredient contained in Brisdelle) The patient originally developed the lesions after treatment with escitalopram. The lesions disappeared one week following discontinuation of escitalopram and reappeared upon rechallenge. When the patient was switched to paroxetine a similar reaction occurred.
Very common (10% or more): Sweating
Common (1% to 10%): Eczema, hypertension, photosensitivity, pruritus, rash, sweat gland disorder
Uncommon (0.1% to 1%): Acne, alopecia, contact dermatitis, dry skin, ecchymosis, furunculosis, purpura, urticaria
Rare (0.01% to 0.1%): Angioedema, erythema multiforme, erythema nodosum, exfoliative dermatitis, fungal dermatitis, hirsutism, maculopapular rash, pustular rash, seborrhea, skin discoloration, skin hypertrophy, skin ulcer, sweating decreased, vesiculobullous rash
Very rare (less than 0.01%): Severe cutaneous reactions such as Stevens Johnson syndrome and toxic epidermal necrolysis)
Postmarketing reports: Vasculitic syndromes (such as Henoch-Schonlein purpura)Endocrine
Rare (less than 0.1%): Goiter, hyperthyroidism, hypothyroidism, thyroiditis
Postmarketing reports: Syndrome of inappropriate antidiuretic hormone secretion, symptoms suggestive of prolactinemiaGastrointestinal
A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed up to 3.2 times more frequently in patients receiving paroxetine (the active ingredient contained in Brisdelle)
Very common (10% or more): Constipation, diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, dyspepsia, flatulence, gastrointestinal disorder, gingivitis, stomatitis, tooth disorder, vomiting
Uncommon (0.1% to 1%): Buccal cavity disorders, colitis, dysphagia, eructation, gastritis, gastroenteritis, gastroesophageal reflux, gastrointestinal flu, gingivitis, glossitis, increased salivation, melena, pancreatitis, rectal hemorrhage, toothache, ulcerative stomatitis
Rare (less than 0.1%): Aphthous stomatitis, bloody diarrhea, cardiospasm, cholelithiasis, duodenitis, enteritis, esophagitis, fecal impaction, fecal incontinence, gum hemorrhage, gum hyperplasia, hematemesis, ileitis, ileus, intestinal obstruction, mouth ulceration, peptic ulcer, peritonitis, salivary gland enlargement, sialadenitis, stomach ulcer, tooth caries, tongue discoloration, tongue edema, tooth malformation
Postmarketing reports: Acute pancreatitis, pancreatitis hemorrhagicHematologic
Uncommon (0.1% to 1%): Anemia, eosinophilia, hypochromic anemia, leukocytosis, leukopenia, lymphadenopathy, WBC abnormality
Rare (less than 0.1%): Abnormal erythrocytes, abnormal lymphocytes, anisocytosis, basophilia, bleeding time increased, iron deficiency anemia, lymphedema, lymphocytosis, lymphopenia, microcytic anemia, monocytosis, normocytic anemia, thrombocytopenia, thrombocythemia,
Postmarketing reports: Events related to impaired hematopoiesis (including aplastic anemia, pancytopenia, bone marrow aplasia, agranulocytosis), hemolytic anemia, idiopathic thrombocytopenic purpuraHepatic
Uncommon (0.1% to 1%): Abnormal liver function tests, SGOT increased, SGPT increased
Rare (less than 0.1%): Bilirubinemia, hepatitis, hepatosplenomegaly, jaundice
Postmarketing reports: Drug-induced liver injury, elevated liver function tests, hepatic failure
In placebo-controlled clinical trials patients receiving paroxetine experienced abnormal values on liver function tests at a rate equal to or less than that reported in patients receiving placebo. However, there have been postmarketing reports of patients developing elevated serum transaminases resulting in severe liver dysfunction, as well as, a few cases of elevated liver function tests resulting in death secondary to liver necrosis.Hypersensitivity
Uncommon (0.1% to 1%): Allergic reaction, face edema
Rare (less than 0.1%): Anaphylactoid reaction
Postmarketing reports: AnaphylaxisImmunologic
Common (1% to 10%): Infection
Uncommon (0.1% to 1%): Flu syndrome, herpes simplex
Rare (less than 0.1%): Herpes zoster, moniliasisMusculoskeletal
Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.
Common (1% to 10%): Arthralgia, back pain, migraine, myalgia, myasthenia, myopathy
Uncommon (0.1% to 1%): Arthritis, arthrosis, bursitis, myositis, neck pain, tendonitis, traumatic fracture
Rare (less than 0.1%): Cartilage disorder, generalized spasm, myositis, neck rigidity, osteoporosis, tenosynovitis, tetanyOcular
Common (1% to 10%): Abnormality of accommodation, abnormal vision, blurred vision
Uncommon (0.1% to 1%): Conjunctivitis, eye pain, keratoconjunctivitis, mydriasis, photophobia, retinal hemorrhage
Rare (less than 0.1%): Anisocoria, blepharitis, cataract, conjunctival edema, corneal lesion, corneal ulcer, diplopia, exophthalmos, eye hemorrhage, glaucoma, hyperacusis, night blindness, ptosis, visual field defect
Frequency not reported: Angle-closure glaucoma, eye pain
Postmarketing reports: Acute glaucoma, optic neuritisRenal
Rare (less than 0.1%): Abnormal kidney function, BUN increased
Postmarketing reports: Acute renal failureRespiratory
Common (1% to 10%): Bronchitis, cough increased, oropharynx disorder, pharyngitis, respiratory disorder, rhinitis, sinusitis, yawn
Uncommon (0.1% to 1%): Asthma, dyspnea, epistaxis, hyperventilation, laryngitis, pneumonia, respiratory flu
Rare (less than 0.1%): Dysphonia, emphysema, hemoptysis, hiccups, lung fibrosis, parosmia, pulmonary edema, pulmonary embolus, sputum increased, stridor, throat tightness, voice alteration
Postmarketing reports: Allergic alveolitis, laryngismus, pulmonary hypertension
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