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Zoloft (sertraline) is an antidepressant belonging to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may be unbalanced in people with depression, panic, anxiety, or obsessive-compulsive symptoms.
Zoloft is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).
Zoloft may also be used for purposes not listed in this medication guide.
You should not use Zoloft if you also take pimozide, or if you are being treated with methylene blue injection.
Do not use Zoloft if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
You should not use Zoloft if you are allergic to sertraline, or if you also take pimozide. Do not use the liquid form of Zoloft if you are taking disulfiram (Antabuse) or you could have a severe reaction to the disulfiram.
Do not take Zoloft within 14 days before or 14 days after you take an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.
To make sure Zoloft is safe for you, tell your doctor if you have ever had:
heart disease, high blood pressure, or a stroke;
liver or kidney disease;
a seizure;
bleeding problems, or if you take warfarin (Coumadin, Jantoven);
bipolar disorder (manic depression); or
low levels of sodium in your blood.
Some medicines can interact with sertraline and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, other antidepressants, or medicine for mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking Zoloft during pregnancy without your doctor's advice.
It is not known whether sertraline passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give Zoloft to anyone younger than 18 years old without the advice of a doctor. Zoloft is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.
Take Zoloft exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Zoloft may be taken with or without food. Try to take the medicine at the same time each day.
The liquid (oral concentrate) form of Zoloft must be diluted before you take it. To be sure you get the correct dose, measure the liquid with the medicine dropper provided. Mix the dose with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not use any other liquids to dilute the medicine. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.
Zoloft can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking Zoloft.
It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Do not stop using Zoloft suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not drink alcohol.
Ask your doctor before taking any medications that effect blood clotting, such as warfarin, other anticoagulants, or nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using any of these medications with Zoloft may cause you to bruise or bleed easily.
Zoloft may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Get emergency medical help if you have signs of an allergic reaction to Zoloft: skin rash or hives (with or without fever or joint pain); difficulty breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
a seizure (convulsions);
blurred vision, tunnel vision, eye pain or swelling;
low levels of sodium in the body - headache, confusion, memory problems, severe weakness, feeling unsteady; or
manic episodes - racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common Zoloft side effects may include:
drowsiness, tiredness, feeling dizziness, anxious or agitated;
indigestion, nausea, diarrhea, loss of appetite;
sweating;
tremors or shaking;
sleep problems (insomnia); or
decreased sex drive, impotence, or difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Taking Zoloft with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking a sleeping pill, narcotic medication, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with sertraline, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zoloft only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zoloft (www.drugs.com/zoloft.html).
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 SummaryCommon 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 ConsumerApplies to sertraline: oral solution, oral tablet
Oral route (Solution; Tablet)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults older than 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD).
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
Less common or rare
Incidence not known
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
Less common
Incidence not known
For Healthcare Professionals
Applies to sertraline: oral concentrate, oral tablet
GeneralThe 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.
PsychiatricAntidepressants 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
Nervous systemVery 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.
CardiovascularCommon (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
GastrointestinalVery 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.
MetabolicThe 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
OtherVery 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
GenitourinaryIn 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
DermatologicCommon (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
EndocrineEndocrine 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)
HematologicUncommon (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
HepaticUncommon (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.
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity
Rare (less than 0.1%): Anaphylactoid reaction
Frequency not reported: Allergy, anaphylaxis
Postmarketing reports: Allergic reaction, angioedema, serum sickness
ImmunologicUncommon (0.1% to 1%): Herpes simplex
MusculoskeletalCommon (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.
OcularCommon (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
OncologicThere 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
RenalUncommon (0.1% to 1%): Cystitis
Postmarketing reports: Acute renal failure
RespiratoryCommon (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
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zoloft (www.drugs.com/zoloft.html).
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