Zoloft

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.

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.

Applies to sertraline: 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)

Applies to sertraline: oral concentrate, oral tablet

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.

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.

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

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.

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

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.

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.

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

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

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.

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

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

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.

Uncommon (0.1% to 1%): Hypothyroidism

Frequency not reported: Gynecomastia

Postmarketing reports: Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion (SIADH)

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

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.

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

Uncommon (0.1% to 1%): Herpes simplex

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.

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

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.

Rare (less than 0.1%): Neoplasm

Uncommon (0.1% to 1%): Cystitis

Postmarketing reports: Acute renal failure

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