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Zoloft Side Effects

Generic Name: sertraline

Note: This document contains side effect information about sertraline. Some of the dosage forms listed on this page may not apply to the brand name Zoloft.

In Summary

Common side effects of Zoloft 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 capsule, oral solution, oral tablet

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:

More common
  • Decreased sexual desire or ability
  • failure to discharge semen (in men)
Less common or rare
  • Aggressive reaction
  • breast tenderness or enlargement
  • confusion
  • convulsions
  • diarrhea
  • drowsiness
  • dryness of the mouth
  • fast talking and excited feelings or actions that are out of control
  • fever
  • inability to sit still
  • increase in body movements
  • increased sweating
  • increased thirst
  • lack of energy
  • loss of bladder control
  • mood or behavior changes
  • muscle spasm or jerking of all extremities
  • nosebleeds
  • overactive reflexes
  • racing heartbeat
  • red or purple spots on the skin
  • restlessness
  • shivering
  • skin rash, hives, or itching
  • sudden loss of consciousness
  • unusual or sudden body or facial movements or postures
  • unusual secretion of milk (in females)
Incidence not known
  • Abdominal or stomach pain
  • bleeding gums
  • blindness
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine
  • bloody, black, or tarry stools
  • blue-yellow color blindness
  • blurred vision
  • chest pain or discomfort
  • chills
  • clay-colored stools
  • cough or hoarseness
  • darkened urine
  • decreased urine output
  • decreased vision
  • depressed mood
  • difficulty with breathing
  • difficulty with speaking
  • difficulty with swallowing
  • drooling
  • dry skin and hair
  • eye pain
  • fainting
  • feeling cold
  • feeling of discomfort
  • feeling, seeing, or hearing things that are not there
  • general feeling of discomfort, illness, tiredness, or weakness
  • hair loss
  • high fever
  • high or low blood pressure
  • hoarseness or husky voice
  • hostility
  • increased clotting times
  • indigestion
  • inflamed joints
  • irritability
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • lightheadedness
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • lower back or side pain
  • muscle aches
  • muscle cramps and stiffness
  • muscle trembling, jerking, or stiffness
  • muscle twitching
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • rash
  • red, irritated eyes
  • red, sore, or itching skin
  • right upper stomach pain and fullness
  • severe mood or mental changes
  • severe muscle stiffness
  • shuffling walk
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sores, welting, or blisters
  • stiffness of the limbs
  • sweating
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • troubled breathing
  • twisting movements of the body
  • twitching
  • uncontrolled movements, especially of the face, neck, and back
  • unexplained bleeding or bruising
  • unpleasant breath odor
  • unusual behavior
  • unusual tiredness or weakness
  • vomiting of blood
  • weight gain
  • yellow eyes and skin

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:

More common
  • Acid or sour stomach
  • belching
  • decreased appetite or weight loss
  • diarrhea or loose stools
  • heartburn
  • sleepiness or unusual drowsiness
  • stomach or abdominal cramps, gas, or pain
  • trouble sleeping
Less common
  • Agitation, anxiety, or nervousness
  • bladder pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in vision
  • cloudy urine
  • constipation
  • difficult, burning, or painful urination
  • flushing or redness of the skin, with feeling of warmth or heat
  • frequent urge to urinate
  • increased appetite
  • pain or tenderness around the eyes and cheekbones
  • stuffy or runny nose
Incidence not known
  • Flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased urination
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the breasts (in women)
  • unexplained weight loss
  • unusual secretion of milk (in women)

For Healthcare Professionals

Applies to sertraline: 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

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]

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]

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

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

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

There was one case of neoplasm reported in one patient receiving sertraline (the active ingredient contained in Zoloft) 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]

References

1. "Product Information. Zoloft (sertraline)." Roerig Division, New York, NY.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Some side effects of Zoloft may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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