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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.

Important warnings This medicine can cause some serious health issues

Oral route (solution; tablet)

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies.

Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.

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:

More common

  • decreased interest in sexual intercourse
  • failure to discharge semen (in men)
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance

Less common or rare

  • aggressive reaction
  • breast tenderness or enlargement
  • confusion
  • 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
  • seizures
  • 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

  • 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, discomfort, or tightness
  • chills
  • clay-colored stools
  • cough or hoarseness
  • darkened urine
  • decreased urine output
  • decreased vision
  • delayed or inability to have an orgasm
  • 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
  • stomach pain
  • sweating
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • talking or acting with excitement you cannot control
  • trouble 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

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:

More common

  • acid or sour stomach
  • belching
  • decreased appetite or weight loss
  • diarrhea or loose stools
  • heartburn
  • sleepiness or unusual drowsiness
  • stomach 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

  • decrease in smell
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased urination
  • loss of sense of smell
  • 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 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

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

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

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]

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]

Other

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]

Dermatologic

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]

Hematologic

Hepatic

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

Hypersensitivity

Immunologic

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]

Ocular

Oncologic

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

Renal

Respiratory

References

1. (2001) "Product Information. Zoloft (sertraline)." Roerig Division

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

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

Frequently asked questions

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.