Side Effects > Sertraline

Sertraline Side Effects

Brand Names: Zoloft

Please note - some side effects for Sertraline may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Sertraline - for the Consumer

Sertraline

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sertraline:

Anxiety; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; tiredness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Sertraline:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased bladder control; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

Sertraline Concentrate

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sertraline Concentrate:

Anxiety; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; increased sweating; loss of appetite; nausea; nervousness; stomach upset; tiredness; trouble sleeping; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Sertraline Concentrate:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased bladder control; decreased concentration; decreased coordination; exaggerated reflexes; fainting; fast or irregular heartbeat; fever; hallucinations; memory loss; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears; persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe or persistent anxiety or trouble sleeping; severe or persistent headache; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.

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Sertraline Side Effects - for the Professional

Sertraline

During its premarketing assessment, multiple doses of Sertraline hydrochloride were administered to over 4000 adult subjects as of February 18, 2000. The conditions and duration of exposure to Sertraline hydrochloride varied greatly, and included (in overlapping categories) clinical pharmacology studies, open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies, and studies for multiple indications, including major depressive disorder and PMDD.

Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.

In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of Sertraline hydrochloride who experienced a treatment-emergent adverse event of the type cited on at least one occasion while receiving Sertraline hydrochloride. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. It is important to emphasize that events reported during therapy were not necessarily caused by it.

The prescriber should be aware that the figures in the tables and tabulations cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.

Incidence in Placebo-Controlled Trials

Table 2 enumerates the most common treatment-emergent adverse events associated with the use of Sertraline hydrochloride (incidence of at least 5% for Sertraline hydrochloride and at least twice that for placebo) for the treatment of adult patients with major depressive disorder/other* in placebo-controlled clinical trials. Most patients in major depressive disorder/other* and PMDD studies received doses of 50 to 200 mg/day.

Patients in the PMDD study with daily dosing throughout the menstrual cycle received doses of 50 to 150 mg/day, and in the PMDD study with dosing during the luteal phase of the menstrual cycle received doses of 50 to 100 mg/day.

TABLE 2
MOST COMMON TREATMENT-EMERGENT ADVERSE EVENTS:
INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS

			Percentage of Patients Reporting Event
	Major Depressive Disorder/Other*		PMDD Daily Dosing		PMDD Luteal Phase Dosing(2)
Body System/Adverse Event	Sertraline Hydrochloride  (N=861)	Placebo (N=853)	Sertraline Hydrochloride  (N=121)	Placebo (N=122)	Sertraline Hydrochloride (N=136)	Placebo (N=127)
Autonomic Nervous System Disorders
Ejaculation Failure(1)	7	<1	N/A	N/A	N/A	N/A
Mouth Dry	16	9	6	3	10	3
Sweating Increased	8	3	6	<1	3	0
Center. & Periph. Nerv. System Disorders
Somnolence	13	6	7	<1	2	0
Tremor	11	3	2	0	<1	<1
Dizziness	12	7	6	3	7	5
General
Fatigue	11	8	16	7	10	<1
Pain	1	2	6	<1	3	2
Malaise	<1	1	9	5	7	5
Gastrointestinal Disorders
Abdominal Pain	2	2	7	<1	3	3
Anorexia	3	2	3	2	5	0
Constipation	8	6	2	3	1	2
Diarrhea/Loose Stools	18	9	13	3	13	7
Dyspepsia	6	3	7	2	7	3
Nausea	26	12	23	9	13	3
Psychiatric Disorders
Agitation	6	4	2	<1	1	0
Insomnia	16	9	17	11	12	10
Libido Decreased	1	<1	11	2	4	2

(1)Primarily ejaculatory delay. Denominator used was for male patients only (N=271 Sertraline hydrochloride major depressive disorder/other*; N=271 placebo major depressive disorder/other*; No male patients in PMDD studies.
*Major depressive disorder and other premarketing controlled trials.

(2)The luteal phase and daily dosing PMDD trials were not designed for making direct comparisons between the two dosing regimens. Therefore, a comparison between the two dosing regimens of the PMDD trials of incidence rates shown in Table 2 should be avoided.

Associated with Discontinuation in Placebo-Controlled Clinical Trials

Table 3 lists the adverse events associated with discontinuation of Sertraline treatment (incidence at least twice that for placebo and at least 1% for Sertraline in clinical trials) in major depressive disorder/other*and PMDD.  

TABLE 3
MOST COMMON ADVERSE EVENTS ASSOCIATED WITH DISCONTINUATION
IN PLACEBO-CONTROLLED CLINICAL TRIALS

Adverse Event	Major Depressive Disorder/ Other* (N=861)	PMDD Daily Dosing (N=121)	PMDD Luteal Phase Dosing (N=136)
Abdominal Pain	–	–	–
Agitation	1%	–	–
Anxiety	–	–	–
Diarrhea/ Loose Stools	2%	2%	–
Dizziness	–	–	–
Dry Mouth	1%	–	–
Dyspepsia	–	–	–
Ejaculation Failure(1)	1%	N/A	N/A
Fatigue	–	–	–
Headache	2%	–	–
Hot Flushes	–	–	1%
Insomnia	1%	–	1%
Nausea	4%	2%	1%
Nervousness	–	2%	–
Palpitation	–	–	1%
Somnolence	1%	–	–
Tremor	2%	–	–

(1)Primarily ejaculatory delay. Denominator used was for male patients only
   (N=271 major depressive disorder/other*; No male patients in PMDD studies.
*Major depressive disorder and other premarketing controlled trials.

Male and Female Sexual Dysfunction with SSRIs

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 pharmacologic treatment.  In particular, some evidence suggests that selective serotonin reuptake inhibitors (SSRIs) can cause such untoward sexual experiences.  Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them.  Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling, are likely to underestimate their actual incidence.

Table 4 below displays the incidence of sexual side effects reported by at least 2% of patients taking Sertraline hydrochloride in placebo-controlled trials.

TABLE 4

Adverse Event	Sertraline	Placebo
Ejaculation failure*(primarily delayed ejaculation)	14%	1%
Decreased libido**	6%	1%

*Denominator used was for male patients only (N=1118 Sertraline; N=926 placebo)
**Denominator used was for male and female patients (N=2799 Sertraline hydrochloride; N=2394 placebo)

There are no adequate and well-controlled studies examining sexual dysfunction with Sertraline treatment.

Priapism has been reported with all SSRIs.

While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.

Other Adverse Events in Pediatric Patients

In over 600 pediatric patients treated with Sertraline, the overall profile of adverse events was generally similar to that seen in adult studies. However, the following adverse events, from controlled trials, not appearing in Tables 2 and 3, were reported at an incidence of at least 2% and occurred at a rate of at least twice the placebo rate (N=281 patients treated with Sertraline): fever, hyperkinesia, urinary incontinence, aggressive reaction, sinusitis, epistaxis and purpura.

Other Events Observed During the Premarketing Evaluation of Sertraline Hydrochloride

Following is a list of treatment-emergent adverse events reported during premarketing assessment of Sertraline hydrochloride in clinical trials (over 4000 adult subjects) except those already listed in the previous tables or elsewhere in labeling.

In the tabulations that follow, a World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the over 4000 adult individuals exposed to multiple doses of Sertraline hydrochloride who experienced an event of the type cited on at least one occasion while receiving Sertraline hydrochloride. All events are included except those already listed in the previous tables or elsewhere in labeling and those reported in terms so general as to be uninformative and those for which a causal relationship to Sertraline hydrochloride treatment seemed remote. It is important to emphasize that although the events reported occurred during treatment with Sertraline, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients. Events of major clinical importance are also described in the PRECAUTIONS section.

Autonomic Nervous System Disorders–Frequent: impotence; Infrequent: flushing, increased saliva, cold clammy skin, mydriasis; Rare: pallor, glaucoma, priapism, vasodilation.

Body as a Whole–General Disorders–Rare: allergic reaction, allergy.

Cardiovascular–Frequent: palpitations, chest pain; Infrequent: hypertension, tachycardia, postural dizziness, postural hypotension, periorbital edema, peripheral edema, hypotension, peripheral ischemia, syncope, edema, dependent edema; Rare: precordial chest pain, substernal chest pain, aggravated hypertension, myocardial infarction, cerebrovascular disorder.

Central and Peripheral Nervous System Disorders–Frequent: hypertonia, hypoesthesia; Infrequent: twitching, confusion, hyperkinesia, vertigo, ataxia, migraine, abnormal coordination, hyperesthesia, leg cramps, abnormal gait, nystagmus, hypokinesia; Rare: dysphonia, coma, dyskinesia, hypotonia, ptosis, choreoathetosis, hyporeflexia.

Disorders of Skin and Appendages–Infrequent: pruritus, acne, urticaria, alopecia, dry skin, erythematous rash, photosensitivity reaction, maculopapular rash; Rare: follicular rash, eczema, dermatitis, contact dermatitis, bullous eruption, hypertrichosis, skin discoloration, pustular rash.

Endocrine Disorders–Rare: exophthalmos, gynecomastia.

Gastrointestinal Disorders–Frequent: appetite increased; Infrequent: dysphagia, tooth caries aggravated, eructation, esophagitis, gastroenteritis; Rare: melena, glossitis, gum hyperplasia, hiccup, stomatitis, tenesmus, colitis, diverticulitis, fecal incontinence, gastritis, rectum hemorrhage, hemorrhagic peptic ulcer, proctitis, ulcerative stomatitis, tongue edema, tongue ulceration.

General–Frequent: back pain, asthenia, malaise, weight increase; Infrequent: fever, rigors, generalized edema; Rare: face edema, aphthous stomatitis.

Hearing and Vestibular Disorders–Rare: hyperacusis, labyrinthine disorder.

Hematopoietic and Lymphatic–Rare: anemia, anterior chamber eye hemorrhage.

Liver and Biliary System Disorders–Rare: abnormal hepatic function.

Metabolic and Nutritional Disorders–Infrequent: thirst; Rare: hypoglycemia, hypoglycemia reaction.

Musculoskeletal System Disorders–Frequent: myalgia; Infrequent: arthralgia, dystonia, arthrosis, muscle cramps, muscle weakness.

Psychiatric Disorders–Frequent: yawning, other male sexual dysfunction, other female sexual dysfunction; Infrequent: depression, amnesia, paroniria, teeth-grinding, emotional lability, apathy, abnormal dreams, euphoria, paranoid reaction, hallucination, aggressive reaction, aggravated depression, delusions; Rare: withdrawal syndrome, suicide ideation, libido increased, somnambulism, illusion.

Reproductive–Infrequent: menstrual disorder, dysmenorrhea, intermenstrual bleeding, vaginal hemorrhage, amenorrhea, leukorrhea; Rare: female breast pain, menorrhagia, balanoposthitis, breast enlargement, atrophic vaginitis, acute female mastitis.

Respiratory System Disorders–Frequent: rhinitis; Infrequent: coughing, dyspnea, upper respiratory tract infection, epistaxis, bronchospasm, sinusitis; Rare: hyperventilation, bradypnea, stridor, apnea, bronchitis, hemoptysis, hypoventilation, laryngismus, laryngitis.

Special Senses–Frequent: tinnitus; Infrequent: conjunctivitis, earache, eye pain, abnormal accommodation; Rare: xerophthalmia, photophobia, diplopia, abnormal lacrimation, scotoma, visual field defect.

Urinary System Disorders–Infrequent: micturition frequency, polyuria, urinary retention, dysuria, nocturia, urinary incontinence; Rare: cystitis, oliguria, pyelonephritis, hematuria, renal pain, strangury.

Laboratory Tests

In man, asymptomatic elevations in serum transaminases (SGOT [or AST] and SGPT [or ALT]) have been reported infrequently (approximately 0.8%) in association with Sertraline hydrochloride administration. These hepatic enzyme elevations usually occurred within the first 1 to 9 weeks of drug treatment and promptly diminished upon drug discontinuation.

Sertraline hydrochloride therapy was associated with small mean increases in total cholesterol (approximately 3%) and triglycerides (approximately 5%), and a small mean decrease in serum uric acid (approximately 7%) of no apparent clinical importance.

The safety profile observed with Sertraline treatment in patients with major depressive disorder, and PMDD is similar.

Other Events Observed During the Post marketing Evaluation of Sertraline Hydrochloride

Reports of adverse events temporally associated with Sertraline hydrochloride that have been received since market introduction, that are not listed above and that may have no causal relationship with the drug, include the following: acute renal failure, anaphylactoid reaction, angioedema, blindness, optic neuritis, cataract, increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including torsade de pointes-type arrhythmias), hypothyroidism, agranulocytosis, aplastic anemia and pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, hyperglycemia, galactorrhea, hyperprolactinemia, extrapyramidal symptoms, oculogyric crisis, serotonin syndrome, psychosis, pulmonary hypertension, severe skin reactions, which potentially can be fatal, such as Stevens-Johnson syndrome, vasculitis, photosensitivity and other severe cutaneous disorders, rare reports of pancreatitis, and liver events—clinical features (which in the majority of cases appeared to be reversible with discontinuation of Sertraline hydrochloride) occurring in one or more patients include: elevated enzymes, increased bilirubin, hepatomegaly, hepatitis, jaundice, abdominal pain, vomiting, liver failure and death.

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Side Effects by Body System

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.

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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