Sertraline Side Effects

Some side effects of sertraline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to sertraline: oral concentrate, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking sertraline: 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:

• 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.

Common 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.

For Healthcare Professionals

Applies to sertraline: oral concentrate, oral tablet

Gastrointestinal

Gastrointestinal side effects including nausea are the most common adverse effects caused by sertraline. One report has suggested that as many as 30% of patients treated with sertraline experience nausea, although most other studies have suggested a lower frequency. Other reported gastrointestinal effects include dry mouth (14% to 20%), diarrhea (17%), constipation, upper GI bleeding, and dyspepsia.

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.

Nervous system

Although sertraline usually causes stimulation, cases of sedation in some patients have been reported.

In one case, a patient with an AV malformation in the region of the corpus callosum developed akathisia and a dystonic reaction following a two week exposure to sertraline.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Nervous system side effects including insomnia, somnolence, tremor, dizziness, headache, and fatigue have all been reported. The incidence of each of these effects ranges between 10% and 20% of treated patients. Akathisia, myoclonic jerking, and sleep abnormalities have also been reported. At higher doses, drowsiness often ensues. Increased alertness and enhanced cognition have been reported when sertraline is taken at low doses. Excitement has been reported less frequently. Sertraline-induced facial paresthesia has also been reported.

Psychiatric

Psychiatric side effects including agitation and changes to hypomania have been observed infrequently. Although the drug has been reported to be an effective agent in the treatment of panic attacks, several cases of sertraline- induced panic attacks have been reported.

General

General side effects including weight loss have been reported frequently.

Genitourinary

Genitourinary side effects including male sexual dysfunction (involving ejaculatory delay, impotence, and decreased libido) have been reported in as many as 21% of treated patients. In a study involving patients receiving sertraline (50 to 200 mg daily) for the treatment of generalized anxiety disorder, 17% of patients reported a decrease or loss of libido. Among male patients, nearly 18% experienced some type of sexual dysfunction including abnormal orgasm/anorgasmia (10%), ejaculation failure (6%), and erectile disturbance (1.5%).

A single case of priapism has been reported in association with sertraline therapy. The patient was also taking lithium at the time.

Hepatic

Hepatic side effects including reversible elevations in liver function tests have been reported to occur in about 0.5% of treated patients.

Cardiovascular

Cardiovascular side effects including rare cases of hypertension, angina, and arrhythmias have been reported.

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.

Other

Other side effects including a withdrawal syndrome have been reported. In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least one qualitatively new symptom were defined in the sertraline group at a rate of 1.5%.

Other side effects including speech difficulties (which included stuttering and speech blockage) have been reported. At least one case of sertraline-related night sweats has also been reported.

A case of withdrawal symptoms involving fatigue, abdominal cramps, insomnia, aching and chills has been reported following the abrupt discontinuation of sertraline. In another case, a patient developed dizziness and orthostatic hypotension on repeated attempts to discontinue the drug.

The night sweats stopped within four days of discontinuation of sertraline therapy. When the patient was changed to fluoxetine, the sweating did not recur.

Hematologic

Hematologic side effects including a case of septic shock secondary to agranulocytosis has been reported. A single case report has suggested that sertraline may improve platelet counts in patients with idiopathic thrombocytopenia purpura.

Ocular

Ocular side effects including "abnormal vision" may occur in some patients according to one report. The specific abnormalities observed were not described by the authors.

Dermatologic

Dermatologic side effects including alopecia (1%) have been reported. A case of photosensitivity has also been reported.

Musculoskeletal

Musculoskeletal side effects may include increased odds of a hip fracture. In one study using the healthcare data from the province of Ontario, Canada reviewing 8,239 patients treated for hip fractures, the adjusted odds ratio for hip fracture was 2.4 for exposure to selective serotonin reuptake inhibitors (including fluoxetine, fluvoxamine, paroxetine, and sertraline), compared to participants who had no exposure to antidepressants.

Renal

Renal side effects including a mean decrease in serum uric acid levels of approximately 7% have been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported in elderly patients. An increase in serum cholesterol has been reported following use of sertraline.

The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine, sertraline, citalopram) 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.

Respiratory

Respiratory side effects have included upper respiratory tract infection. In a study involving 314 women with moderate to severe premenstrual syndrome, 6% to 10% of patients developed upper respiratory tract infection after receiving sertraline 25 to 50 mg daily. However, it should be noted that 7% of placebo- treated patients also developed upper respiratory tract infection.

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