Zoloft Side Effects

Generic Name: sertraline

Note: This page contains side effects data for the generic drug sertraline. It is possible that some of the dosage forms included below may not apply to the brand name Zoloft.

It is possible that some side effects of Zoloft may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, sertraline (the active ingredient contained in Zoloft) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sertraline, check with your doctor immediately:

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 sertraline side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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
Common (1% to 10%): Abnormal thinking, affect/emotional lability, agitation, anxiety, bruxism, depersonalization, depression, nervousness, nightmare, mania, paroniria
Uncommon (0.1% to 1%): Abnormal dreams, aggravated depression, aggressive reaction, apathy, delusions, euphoria, hallucination, paranoid reaction
Rare (less than 0.1%): Conversion disorder, drug dependence, dysphonia, illusion, psychotic disorder, sleep walking, suicide attempt, suicide ideation/behavior, withdrawal syndrome
Postmarketing reports: Depressive symptoms, manic reaction, psychomotor restlessness, psychosis[Ref]

Nervous system

Very common (10% or more): Dizziness, headache, somnolence, tremor
Common (1% to 10%): Convulsions (including myoclonus), disturbance in attention, dysgeusia, hypertonia, hyperkinesia, hypoesthesia, impaired concentration, paresthesia
Uncommon (0.1% to 1%): Abnormal coordination, abnormal gait, amnesia, ataxia, confusion, dystonia, hyperesthesia, hypokinesia, involuntary muscle contractions, leg cramps, migraine, nystagmus, postural dizziness, speech disorder, syncope
Rare (less than 0.1%): Cerebrovascular disorder, choreoathetosis, coma, dyskinesia, hyporeflexia, hypotonia, sensory disturbance, somnambulism
Postmarketing reports: Akathisia, cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), extrapyramidal symptoms, gait abnormalities, movement disorders, neuroleptic malignant syndrome, oculogyric crisis, serotonin syndrome[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, palpitations
Uncommon (0.1% to 1%): Edema, dependent edema, flushing, generalized edema, hot flush, hypertension, hypotension, peripheral edema, peripheral ischemia, postural dizziness, postural hypotension, tachycardia
Rare (less than 0.1%): Aggravated hypertension, bradycardia, cardiac disorder, myocardial infarction, pallor, precordial chest pain, substernal chest pain, vasodilation, vasodilation procedure
Postmarketing reports: Atrial arrhythmias, AV block, QT-interval prolongation, vasculitis, ventricular tachycardia (including torsade de pointes)[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, constipation, dyspepsia, flatulence, increased saliva, vomiting
Uncommon (0.1% to 1%): Aggravated tooth caries, dysphagia, eructation, esophagitis, gastroenteritis, hemorrhoids, salivary hypersecretion, tongue disorder
Rare (less than 0.1%): Aphthous stomatitis, colitis, diverticulitis, fecal incontinence, gastritis, glossitis, gum hyperplasia, hematochezia, hemorrhagic peptic ulcer, melena, mouth ulceration, proctitis, rectum hemorrhage, stomatitis, tenesmus, tongue ulceration, ulcerative stomatitis
Postmarketing reports: Gastrointestinal bleeding, pancreatitis[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, small mean decrease in serum uric acid, small mean increases in total cholesterol and triglycerides, weight increased/decreased
Uncommon (0.1% to 1%): Thirst
Rare (less than 0.1%): Diabetes mellitus, hypercholesterolemia, hypoglycemia
Postmarketing reports: Hyperglycemia, hyponatremia[Ref]

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Asthenia, fever, malaise, tinnitus
Uncommon (0.1% to 1%): Chills, cold clammy skin, earache, face edema, otitis externa, rigors, vertigo
Rare (less than 0.1%): Drug tolerance decreased, hernia, hyperacusis, injury, labyrinthine disorder, otitis media
Postmarketing reports: Abnormal clinical laboratory results, death[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
Common (1% to 10%): Decreased libido, erectile dysfunction, impotence, menstrual irregularities, other male/female sexual dysfunction, urinary retention, vaginal hemorrhage
Uncommon (0.1% to 1%): Albuminuria, amenorrhea, cystitis, dysmenorrhea, dysuria, menstrual disorder, intermenstrual bleeding, leukorrhea, micturition disorder, nocturia, pollakiuria, polyuria, urinary incontinence
Rare (less than 0.1%): Abnormal semen, acute female mastitis, atrophic vulvovaginitis, balanoposthitis, breast enlargement, female breast pain, galactorrhea, genital discharge, gynecomastia, hematuria, increased libido, menorrhagia, oliguria, premature ejaculation, priapism, strangury, urinary hesitation
Postmarketing reports: Enuresis[Ref]

Dermatologic

Common (1% to 10%): Acne, increased sweating, rash, urticaria
Uncommon (0.1% to 1%): Alopecia, cold sweat, dry skin, erythematous rash, maculopapular rash, photosensitivity reaction, pruritus, purpura, skin disorder
Rare (less than 0.1%): Bullous eruption, contact dermatitis, dermatitis, eczema, follicular rash, hair texture abnormal, hypertrichosis, pustular rash, skin discoloration, skin odor abnormal
Postmarketing reports: Angioedema, hematomas, severe skin reactions (including Stevens-Johnson syndrome and 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
Postmarketing reports: Hyperprolactinemia, syndrome of inappropriate antidiuretic hormone secretion[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia
Rare (less than 0.1%): Lymphadenopathy
Postmarketing reports: Agranulocytosis, altered platelet function, aplastic anemia, increased coagulation times, leukopenia, pancytopenia, thrombocytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Asymptomatic elevations in serum transaminases
Rare (less than 0.1%): Abnormal hepatic function
Postmarketing reports: Elevated hepatic enzymes, hepatomegaly, hepatitis, increased bilirubin, jaundice, liver failure[Ref]

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

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, periorbital edema
Rare (less than 0.1%): Allergic reaction, allergy, anaphylactoid reaction, tongue edema
Postmarketing reports: Serum sickness[Ref]

Immunologic

Uncommon (0.1% to 1%): Herpes simplex[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, myalgia
Uncommon (0.1% to 1%): Arthrosis, muscle cramps, muscle weakness, muscle twitching, osteoarthritis, twitching
Rare (less than 0.1%): Bone disorder
Postmarketing reports: Bone fracture, lupus-like syndrome[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
Uncommon (0.1% to 1%): Abnormal accommodation, conjunctivitis, eye pain, mydriasis
Rare (less than 0.1%): Abnormal lacrimation, angle-closure glaucoma, anterior chamber eye hemorrhage, diplopia, exophthalmos, photophobia, ptosis, scotoma, visual field defect, xerophthalmia
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

Rare (less than 0.1%): Cystitis, pyelonephritis, renal pain
Postmarketing reports: Acute renal failure[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, yawning
Uncommon (0.1% to 1%): Bronchospasm, coughing, dyspnea, epistaxis, sinusitis, upper respiratory tract infection
Rare (less than 0.1%): Apnea, bradypnea, bronchitis, hemoptysis, hiccups, hyperventilation, hypoventilation, laryngismus, laryngitis, 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. "Australian Product Information." O 0

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

4. Dalton SO, Johansen C, Mellemkjaer L, Norgard B, Sorensen HT, Olsen JH "Use of selective serotonin reuptake inhibitors and risk of upper gastrointestinal tract bleeding: a population-based cohort study." Arch Intern Med 163 (2003): 59-64

5. Kline MD, Koppes S "Acidophilus for sertraline-induced diarrhea." Am J Psychiatry 151 (1994): 1521-2

6. Jacob S, Spinler SA "Hyponatremia associated with selective serotonin-reuptake inhibitors in older adults." Ann Pharmacother 40 (2006): 1618-22

7. Herran A, Ramirez ML, Carrera M, et al. "Panic disorder, treatment with selective serotonin reuptake inhibitors, and cholesterol levels." J Clin Psychopharmacol 26 (2006): 538-40

8. Rothschild AJ "Sexual side effects of antidepressants." J Clin Psychiatry 61 (2000): 28-36

9. Lin NC, Chou JY, Chen H, Chen VC "Sertraline-induced photoallergic reaction." J Clin Psychopharmacol 29 (2009): 95-6

10. Bradley ME, Foote EF, Lee EN, Merkle L "Sertraline-associated syndrome of inappropriate antidiuretic hormone: case report and review of the literature." Pharmacotherapy 16 (1996): 680-3

11. "Selective serotonin reuptake inhibitors and SIADH." Med J Aust 164 (1996): 562

12. Thornton SL, Resch DS "SIADH associated with sertraline therapy." Am J Psychiatry 152 (1995): 809

13. Doshi D, Borison R "Association of transient SIADH with sertraline." Am J Psychiatry 151 (1994): 779-80

14. Llorente MD, Gorelick M, Silverman MA "Sertraline as the cause of inappropriate antidiuretic hormone secretion." J Clin Psychiatry 55 (1994): 543-4

15. Bronzo MR, Stahl SM "Galactorrhea induced by sertraline." Am J Psychiatry 150 (1993): 1269-70

16. Kessler J, Samuels SC "Sertraline and hyponatremia." N Engl J Med 335 (1996): 524

17. Crews JR, Potts NL, Schreiber J, Lipper S "Hyponatremia in a patient treated with sertraline." Am J Psychiatry 150 (1993): 1564

18. Jackson C, Carson W, Markowitz J, Mintzer J "SIADH associated with fluoxetine and sertraline therapy." Am J Psychiatry 152 (1995): 809-10

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)