Zoloft Side Effects

Generic name: sertraline

Medically reviewed by Drugs.com. Last updated on Feb 5, 2024.

Note: This document provides detailed information about Zoloft Side Effects associated with sertraline. Some dosage forms listed on this page may not apply specifically to the brand name Zoloft.

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

Serious side effects of Zoloft

Along with its needed effects, sertraline (the active ingredient contained in Zoloft) 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:

Other side effects of Zoloft

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:

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 (the active ingredient contained in Zoloft) 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 (the active ingredient contained in Zoloft) 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

• 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]

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]

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

• 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]

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]

Metabolic

• 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]

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]

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

• 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]

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]

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

• Uncommon (0.1% to 1%): Hypothyroidism
• Frequency not reported: Gynecomastia
• Postmarketing reports: Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)^[Ref]

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]

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

• 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]

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]

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

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

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

Frequently asked questions

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Further information

Zoloft side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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