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Commonly reported side effects of sertraline include: diarrhea, dizziness, drowsiness, dyspepsia, fatigue, insomnia, loose stools, nausea, tremor, headache, paresthesia, anorexia, decreased libido, delayed ejaculation, diaphoresis, ejaculation failure, and xerostomia. Other side effects include: abdominal pain, agitation, pain, vomiting, anxiety, hypouricemia, and malaise. See below for a comprehensive list of adverse effects.For the Consumer
Applies to sertraline: oral solution, oral tablet
Oral route (Solution; Tablet)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).
Along with its needed effects, sertraline 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 sertraline:
Less common or rare
Incidence not known
Some side effects of sertraline 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:
Incidence not known
For Healthcare Professionals
Applies to sertraline: oral concentrate, oral tabletGeneral
The most commonly reported side effect was nausea, which was dose dependent and often transient in nature. The most common side effects associated with discontinuation of sertraline treatment at an incidence at least twice that for placebo and at least 1% for sertraline in clinical trials included abdominal pain, agitation, diarrhea, dizziness, dry mouth, dyspepsia, ejaculation failure, fatigue, headache, hot flushes, insomnia, nausea, nervousness, palpitation, somnolence, and tremor.
The overall profile of side effects in pediatric clinical trials was generally similar to that seen in adult studies. Fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis, and purpura were reported in clinical trials in pediatric patients at an incidence of at least 2% and at a rate of at least twice that of placebo. In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, the incidence of discontinuation due to side effects was reported at 9%; the most common reactions leading to discontinuation were agitation, suicidal ideation, hyperkinesia, suicide attempt, and aggravated depression.Psychiatric
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.
In a 12-week placebo-controlled study in pediatric patients with OCD, side effects observed at an incidence of at least 5% and at a statistically significant increased level for sertraline compared with placebo were insomnia and agitation in 6 to 12 year olds, and insomnia in 13 to 17 year olds.
In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, agitation was reported at a frequency of at least 2% and at least twice that of placebo. Suicide attempt was reported in the same number of patients in the sertraline (2 out of 189) and placebo (2 out of 184) groups. Suicide ideation was reported by 3 sertraline-treated patients and no placebo-treated patients; however the difference was not statistically significant.
Mania, affect lability were also commonly reported in controlled trials in pediatric patients.
Very common (10% or more): Insomnia (up to 21%)
Common (1% to 10%): Affect/emotional lability, aggravated depression, aggressive reaction, aggression, agitation, anxiety, bruxism/teeth grinding, decreased libido, depersonalization, depression, nervousness, nightmare, mania, paroniria, suicidal ideation, suicide attempt
Uncommon (0.1% to 1%): Abnormal dreams, Abnormal thinking, apathy, euphoria/euphoric mood, hallucination
Rare (less than 0.1%): Conversion disorder, drug dependence, paranoia, psychotic disorder, sleep walking, suicide behavior
Frequency not reported: Psychomotor hyperactivity, irritability
Postmarketing reports: Depressive symptoms, intense dreams, manic reaction, psychosis, sleep disturbances, withdrawal syndromeNervous system
Very common (10% or more): Headache (up to 22%), somnolence (up to 13%), dizziness (up to 12%),
Common (1% to 10%): Convulsions (including myoclonus), disturbance in attention, dysgeusia, hypertonia, hyperkinesia, hypoesthesia, impaired concentration, migraine, paresthesia, tremor
Uncommon (0.1% to 1%): Abnormal coordination, amnesia, involuntary muscle contractions, postural dizziness, speech disorder, syncope
Rare (less than 0.1%): Choreoathetosis, coma, dyskinesia, hyperesthesia, sensory disturbance
Frequency not reported: Akathisia, ataxia, cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), confusional state/confusion, decreased alertness, dystonia, extrapyramidal symptoms, gait abnormalities, gait disturbance, movement disorders, neuroleptic malignant syndrome, sensory disturbances, serotonin syndrome
Postmarketing reports: Oculogyric crisis
In a 12-week placebo-controlled study in pediatric patients with OCD, side effects observed at an incidence of at least 5% and at a statistically significant increased level for sertraline compared with placebo were headache (in 6 to 12 year olds) and tremor (in 13 to 17 year olds). In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, hyperkinesia and tremor were reported at a frequency of at least 2% and at least twice that of placebo.
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.Cardiovascular
Common (1% to 10%): Chest pain, hot flush, palpitations
Uncommon (0.1% to 1%): ECG QT prolonged/QTc prolongation, flushing, hypertension, peripheral edema, tachycardia
Rare (less than 0.1%): Bradycardia, cardiac disorder, myocardial infarction, peripheral ischemia, vasodilation procedure
Frequency not reported: Edema, hemorrhage, vasodilation
Postmarketing reports: Atrial arrhythmias, AV block, torsade de pointes, vasculitis, ventricular tachycardiaGastrointestinal
Very common (10% or more): Nausea (up to 26%), diarrhea/loose stools (up to 20%), dry mouth (up to 14%)
Common (1% to 10%): Abdominal pain, constipation, dyspepsia, flatulence, vomiting
Uncommon (0.1% to 1%): Dysphagia, eructation, esophagitis, hemorrhoids, salivary hypersecretion, tongue disorder
Rare (less than 0.1%): Gastroenteritis, glossitis, hematochezia, melena, mouth ulceration, stomatitis, tongue ulceration, tooth disorder
Frequency not reported: Gastrointestinal bleeding, pancreatitis, rectal hemorrhage
There are two cases in the literature in which the use of Lactobacillus acidophilus capsules were reported to have been very helpful in the treatment of persistent, sertraline-induced diarrhea.
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 in 4.1 times more frequently in patients receiving sertraline.
In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder diarrhea, vomiting, and dry mouth were reported at a frequency of at least 2% and at least twice that of placebo.Metabolic
The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors 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.
In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder, anorexia was reported at a frequency of at least 2% and at least twice that of placebo. In a 12-week placebo-controlled study in pediatric patients with OCD, anorexia was observed at an incidence of at least 5% and at a statistically significant increased level for sertraline compared with placebo in 13 to 17 year olds.
Common (1% to 10%): Anorexia, increased/decreased appetite, weight increased/decreased
Uncommon (0.1% to 1%): Thirst
Rare (less than 0.1%): Diabetes mellitus, hypercholesterolemia, hypoglycemia
Frequency not reported: Hyperglycemia, hyponatremiaOther
Very common (10% or more): Fatigue (up to 12%)
Common (1% to 10%): Fever/pyrexia, malaise, tinnitus
Uncommon (0.1% to 1%): Asthenia, chills, ear pain, injury, otitis externa
Rare (less than 0.1%): Drug tolerance decreased, otitis media
Frequency not reported: Lethargy
Postmarketing reports: Abnormal clinical laboratory resultsGenitourinary
In placebo-controlled trials ejaculation failure (primarily delayed ejaculation) in men was reported as a treatment-emergent side effect in 14% of men taking sertraline, compared to 1% in the placebo group. 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.
In clinical trials in children and adolescents aged 6 to 17 years with major depressive disorder urinary incontinence was reported at a frequency of at least 2% and at least twice that of placebo.
Very common (10% or more): Ejaculation failure (up to 14%)
Common (1% to 10%): Ejaculatory delay/disorder, erectile dysfunction, menstrual irregularities, other male/female sexual dysfunction, urinary incontinence, urinary retention, vaginal hemorrhage
Uncommon (0.1% to 1%): Albuminuria, breast pain, cystitis, menstrual disorder, micturition disorder, nocturia, pollakiuria, polyuria, urinary incontinence
Rare (less than 0.1%): Abnormal semen, atrophic vulvovaginitis, balanoposthitis, diverticulitis, galactorrhea, gastroenteritis, genital discharge, hematuria, increased libido, menorrhagia, oliguria, premature ejaculation, priapism, urinary hesitation
Postmarketing reports: EnuresisDermatologic
Common (1% to 10%): Acne, hyperhidrosis/increased sweating, rash, urticaria
Uncommon (0.1% to 1%): Alopecia, cold sweat, dermatitis, dry skin, face edema, pruritus, purpura, pustular rash, skin disorder, skin odor abnormal
Rare (less than 0.1%): Bullous eruption, follicular rash, hair texture abnormal
Frequency not reported: Bullous dermatitis, erythematous/maculopapular rash
Postmarketing reports: Exfoliative skin disorders, hematoma, photosensitivity reaction, severe cutaneous skin reactions (SCAR)/fatal SCAR, skin reaction, Stevens-Johnson syndrome, toxic epidermal necrolysisEndocrine
Endocrine side effects including two cases of galactorrhea have been reported in association with sertraline therapy. Two cases of breast discomfort and enlargement without galactorrhea have also been reported.
Case reports have suggested that sertraline, like other serotonin- specific reuptake inhibitors, may induce the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Seven cases of hyponatremia have been reported, four of which were associated with SIADH. Six of the seven patients were over 60 years of age.
Uncommon (0.1% to 1%): Hypothyroidism
Frequency not reported: Gynecomastia
Postmarketing reports: Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)Hematologic
Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Lymphadenopathy
Frequency not reported: Abnormal bleeding, altered platelet function, leukopenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, aplastic anemia, increased coagulation times, pancytopeniaHepatic
Uncommon (0.1% to 1%): Abnormal hepatic function, ALT/AST increased
Frequency not reported: Elevated hepatic enzymes, hepatitis, jaundice, liver failure, severe liver events
Postmarketing reports: Acute liver failure, asymptomatic elevations in serum transaminases, fatal liver failure
The majority of liver events appear to be reversible upon sertraline treatment cessation.Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity
Rare (less than 0.1%): Anaphylactoid reaction
Frequency not reported: Allergy, anaphylaxis
Postmarketing reports: Allergic reaction, angioedema, serum sicknessImmunologic
Uncommon (0.1% to 1%): Herpes simplexMusculoskeletal
Common (1% to 10%): Arthralgia, myalgia
Uncommon (0.1% to 1%): Back pain, muscle weakness, muscle twitching, osteoarthritis
Rare (less than 0.1%): Bone disorder
Frequency not reported: Muscle cramps/spasms, tightness, twitching
Postmarketing reports: Bone fracture, lupus-like syndrome, rigidity, trismus
Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.Ocular
Common (1% to 10%): Abnormal vision, visual disturbance/impairment
Uncommon (0.1% to 1%): Eye pain, mydriasis, periorbital edema
Rare (less than 0.1%): Diplopia, glaucoma, hyphema, lacrimal disorder, photophobia, scotoma, visual field defect
Frequency not reported: Blurred vision, unequal pupils
Postmarketing reports: Blindness, cataract, optic neuritisOncologic
There was one case of neoplasm reported in one patient receiving sertraline compared to no cases in the placebo-treated group.
Rare (less than 0.1%): NeoplasmRenal
Uncommon (0.1% to 1%): Cystitis
Postmarketing reports: Acute renal failureRespiratory
Common (1% to 10%): Pharyngitis, yawning
Uncommon (0.1% to 1%): Bronchospasm, dyspnea, epistaxis, rhinitis, upper respiratory tract infection
Rare (less than 0.1%): Dysphonia, hiccups, hyperventilation, hypoventilation, laryngospasm, stridor
Frequency not reported: Interstitial lung disease
Postmarketing reports: Pulmonary hypertension
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