Summary

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. Continue reading for a comprehensive list of adverse effects.

Applies to sertraline: oral concentrate solution or tablets.

Side effects include:

Nausea, diarrhea/loose stools, dyspepsia, dry mouth, somnolence, dizziness, insomnia, tremor, ejaculatory delay, sweating.

Adverse effects in children are similar to those reported in adults. (See Pediatric Use under Cautions.)

For Healthcare Professionals

Applies to sertraline: oral capsule, oral concentrate, oral tablet.

General

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.^[Ref]

Psychiatric

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 syndrome^[Ref]

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.^[Ref]

Nervous system

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.^[Ref]

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^[Ref]

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 tachycardia^[Ref]

Gastrointestinal

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.^[Ref]

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^[Ref]

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.^[Ref]

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, hyponatremia^[Ref]

Other

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 results^[Ref]

Genitourinary

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.^[Ref]

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: Enuresis^[Ref]

Dermatologic

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 necrolysis^[Ref]

Endocrine

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.^[Ref]

Uncommon (0.1% to 1%): Hypothyroidism

Frequency not reported: Gynecomastia

Postmarketing reports: Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)^[Ref]

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, pancytopenia^[Ref]

Hepatic

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^[Ref]

The majority of liver events appear to be reversible upon sertraline treatment cessation.^[Ref]

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 sickness^[Ref]

Immunologic

Uncommon (0.1% to 1%): Herpes simplex^[Ref]

Musculoskeletal

Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.^[Ref]

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^[Ref]

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 neuritis^[Ref]

Oncologic

There was one case of neoplasm reported in one patient receiving sertraline compared to no cases in the placebo-treated group.^[Ref]

Rare (less than 0.1%): Neoplasm^[Ref]

Renal

Uncommon (0.1% to 1%): Cystitis

Postmarketing reports: Acute renal failure^[Ref]

Respiratory

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^[Ref]