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Zoloft

Last reviewed on RxList: 12/21/2017
Zoloft Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/21/2017

Zoloft (sertraline) is an SSRI (selective serotonin reuptake inhibitors) antidepressant prescribed for the treatment of depression, obsessive compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). Zoloft is available as a generic drug. Common side effects of Zoloft include:

  • sleepiness
  • drowsiness
  • tired feeling
  • nervousness
  • sleep problems (insomnia)
  • dizziness
  • nausea
  • skin rash
  • headache
  • diarrhea
  • constipation
  • upset stomach
  • stomach pain
  • dry mouth
  • changes in appetite
  • abnormal ejaculation
  • impotence
  • decreased sex drive
  • difficulty having an orgasm
  • dry mouth, and
  • weight loss.

Tell your doctor if you have serious side effects of Zoloft including:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • agitation, hallucinations, fever, overactive reflexes, tremors;
  • nausea, vomiting, loss of appetite, feeling unsteady, loss of coordination;
  • trouble concentrating, memory problems, weakness, fainting, seizure, shallow breathing, or breathing that stops.

Zoloft dosage depends on the condition being treated. Zoloft may interact with nonsteroidal anti-inflammatory drugs (NSAIDs), other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotics, sleeping pills, muscle relaxers, and medicines for seizures or anxiety), cimetidine, digoxin, fentanyl, linezolid, lithium, St. John's wort, tramadol, 5-hydroxytryptophan, valproate, blood thinners, cough and cold medicines, other antidepressants, heart rhythm medications, or migraine headache medicines. Tell your doctor all medications and supplements you use. Zoloft use during pregnancy may lead to adverse effects in the newborn. It is unknown if Zoloft passes into breast milk. Consult your doctor before breastfeeding. In some patients, if Zoloft is discontinued abruptly, withdrawal side effects include abdominal cramps, flu-like symptoms, fatigue, and memory impairment.

Our Zoloft Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Zoloft Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; 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 serious side effect such as:

  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
  • agitation, hallucinations, fever, overactive reflexes, tremors;
  • nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
  • headache, trouble concentrating, memory problems, weakness, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • drowsiness, dizziness, tired feeling;
  • mild nausea, stomach pain, upset stomach, constipation;
  • dry mouth;
  • changes in appetite or weight;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zoloft (Sertraline Hcl)

Zoloft Professional Information

SIDE EFFECTS

The following adverse reactions are described in more detail in other sections of the prescribing information:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below are from randomized, double-blind, placebo-controlled trials of ZOLOFT (mostly 50 mg to 200 mg per day) in 3066 adults diagnosed with MDD, OCD, PD, PTSD, SAD, and PMDD. These 3066 patients exposed to ZOLOFT for 8 to12 weeks represent 568 patient-years of exposure. The mean age was 40 years; 57% were females and 43% were males.

The most common adverse reactions (>5% and twice placebo) in all pooled placebo-controlled clinical trials of all ZOLOFT-treated patients with MDD, OCD, PD, PTSD, SAD and PMDD were nausea, diarrhea/loose stool, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, and decreased libido (see Table 3). The following are the most common adverse reactions in trials of ZOLOFT (>5% and twice placebo) by indication that were not mentioned previously.

  • MDD: somnolence;
  • OCD: insomnia, agitation;
  • PD: constipation, agitation;
  • PTSD: fatigue;
  • PMDD: somnolence, dry mouth, dizziness, fatigue, and abdominal pain;
  • SAD: insomnia, dizziness, fatigue, dry mouth, malaise.

Table 3: Common Adverse Reactions in Pooled Placebo-Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD*

  ZOLOFT
(N=3066)
Placebo
(N=2293)
Cardiac disorders
Palpitations 4% 2%
Eye disorders
Visual impairment 4% 2%
Gastrointestinal Disorders
Nausea 26% 12%
Diarrhea/Loose Stools 20% 10%
Dry mouth 14% 9%
Dyspepsia 8% 4%
Constipation 6% 4%
Vomiting 4% 1%
General disorders and administration site conditions
Fatigue 12% 8%
Metabolism and nutrition disorders
Decreased appetite 7% 2%
Nervous system disorders
Dizziness 12% 8%
Somnolence 11% 6%
Tremor 9% 2%
Psychiatric Disorders
Insomnia 20% 13%
Agitation 8% 5%
Libido Decreased 6% 2%
Reproductive system and breast disorders
Ejaculation failure (1) 8% 1%
Erectile dysfunction (1) 4% 1%
Ejaculation disorder (1) 3% 0%
Male sexual dysfunction (1) 2% 0%
Skin and subcutaneous tissue disorders
Hyperhidrosis 7% 3%
1 Denominator used was for male patients only (n=1316 ZOLOFT; n=973 placebo).
* Adverse reactions that occurred greater than 2% in ZOLOFT-treated patients and at least 2% greater in ZOLOFT-treated patients than placebo-treated patients.

Adverse Reactions Leading To Discontinuation In Placebo-Controlled Clinical Trials

In all placebo-controlled studies in patients with MDD, OCD, PD, PTSD, SAD and PMDD, 368 (12%) of the 3066 patients who received ZOLOFT discontinued treatment due to an adverse reaction, compared with 93 (4%) of the 2293 placebo-treated patients. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in ZOLOFT-treated patients:

  • MDD, OCD, PD, PTSD, SAD and PMDD: nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).
  • MDD (>2% and twice placebo): decreased appetite, dizziness, fatigue, headache, somnolence, tremor, and vomiting.
  • OCD: somnolence.
  • PD: nervousness and somnolence.
Male And Female Sexual Dysfunction

Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.

Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of ZOLOFT-treated patients and twice placebo from pooled placebo-controlled trials. For men and all indications, the most common adverse reactions (>2% and twice placebo) included: ejaculation failure, decreased libido, erectile dysfunction, ejaculation disorder, and male sexual dysfunction. For women, the most common adverse reaction (≥2% and twice placebo) was decreased libido.

Table 4: Most Common Sexual Adverse Reactions (≥2% and twice placebo) in Men or Women from ZOLOFT Pooled Controlled Trials in Adults with MDD, OCD, PD, PTSD, SAD, and PMDD

Men only ZOLOFT
(N=1316)
Placebo
(N=973)
Ejaculation failure 8% 1%
Libido decreased 7% 2%
Erectile dysfunction 4% 1%
Ejaculation disorder 3% 0%
Male sexual dysfunction 2% 0%
Women only (N=1750) (N=1320)
Libido decreased 4% 2%

Adverse Reactions In Pediatric Patients

In 281 pediatric patients treated with ZOLOFT in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.

Other Adverse Reactions Observed During The Premarketing Evaluation Of ZOLOFT

Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with ZOLOFT were:

Cardiac disorders - tachycardia

Ear and labyrinth disorders - tinnitus

Endocrine disorders - hypothyroidism

Eye disorders - mydriasis, blurred vision

Gastrointestinal disorders - hematochezia, melena, rectal hemorrhage

General disorders and administration site conditions - edema, gait disturbance, irritability, pyrexia

Hepatobiliary disorders - elevated liver enzymes

Immune system disorders - anaphylaxis

Metabolism and nutrition disorders - diabetes mellitus, hypercholesterolemia, hypoglycemia, increased appetite

Musculoskeletal and connective tissue disorders - arthralgia, muscle spasms, tightness, or twitching

Nervous system disorders - ataxia, coma, convulsion, decreased alertness, hypoesthesia, lethargy, psychomotor hyperactivity, syncope

Psychiatric disorders - aggression, bruxism, confusional state, euphoric mood, hallucination

Renal and urinary disorders - hematuria

Reproductive system and breast disorders - galactorrhea, priapism, vaginal hemorrhage

Respiratory, thoracic and mediastinal disorders - bronchospasm, epistaxis, yawning

Skin and subcutaneous tissue disorders - alopecia; cold sweat; dermatitis; dermatitis bullous; pruritus; purpura;erythematous, follicular, or maculopapular rash; urticaria

Vascular disorders - hemorrhage, hypertension, vasodilation

Post-marketing Experience

The following adverse reactions have been identified during postapproval use of ZOLOFT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Bleeding or clotting disorders - increased coagulation times (altered platelet function)

Cardiac disorders - AV block, bradycardia, atrial arrhythmias, QTc-interval prolongation, ventricular tachycardia (including Torsade de Pointes) [See CLINICAL PHARMACOLOGY]

Endocrine disorders - gynecomastia, hyperprolactinemia, menstrual irregularities, SIADH

Eye disorders - blindness, optic neuritis, cataract

Hepatobiliary disorders - severe liver events (including hepatitis, jaundice, liver failure with some fatal outcomes), pancreatitis

Hemic and lymphatic disorders - agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness

Immune system disorders - angioedema

Metabolism and nutrition disorders - hyponatremia, hyperglycemia

Musculoskeletal and connective tissue disorders - rhabdomyolysis, trismus

Nervous system disorders - serotonin syndrome, extrapyramidal symptoms (including akathisia and dystonia), oculogyric crisis

Psychiatric disorders - psychosis, enuresis, paroniria

Renal and urinary disorders - acute renal failure

Respiratory, thoracic and mediastinal disorders - pulmonary hypertension

Skin and subcutaneous tissue disorders - photosensitivity skin reaction and other severe cutaneous reactions, which potentially can be fatal, such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)

Vascular disorders - cerebrovascular spasm (including reversible cerebral vasoconstriction syndrome and Call-Fleming syndrome), vasculitis

Read the entire FDA prescribing information for Zoloft (Sertraline Hcl)

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