SERTRALINE   Also explore   Side-Effects

• 0.0 OVERVIEW
• 0.1 LIFE SUPPORT
• A. This overview assumes that basic life support measures have been instituted.
• 0.2 CLINICAL EFFECTS
• 0.2.1 SUMMARY OF EXPOSURE
• A. Serious toxicity has not been reported with known overdoses of sertraline between 700 and 2100 mg. Patients should be monitored for potential cardiovascular, gastrointestinal, or hepatic abnormalities. Few serious sequelae were reported in overdose cases. Seizures have been reported rarely. Serotonin syndrome may result following significant overdose.
• B. PEDIATRIC - Prolonged tachycardia, hypertension, hallucinations, coma, hyperthermia, tremors, and vasodilation have been reported in a pediatric overdose.
• 0.2.3 VITAL SIGNS
• A. Hyperthermia, tachycardia, bradycardia, and hypertension have been reported in an acute overdose.
• 0.2.4 HEENT
• A. Sertraline has caused exophthalmos, xerophthalmia, blurred vision, diplopia, photophobia, tearing, conjunctivitis, eye pain, and mydriasis when used therapeutically.
• 0.2.5 CARDIOVASCULAR
• A. Therapeutic use of sertraline has been associated with palpitations, chest pain, hypertension, hypotension, edema, peripheral ischemia, syncope, and tachycardia.
• B. Overdose of sertraline has been associated with tachycardia, hypertension, and palpitations in a pediatric case.
• 0.2.6 RESPIRATORY
• A. Bronchospasm, dyspnea, cough, and hyperventilation have occasionally been associated with sertraline.
• 0.2.7 NEUROLOGIC
• A. Overdoses have resulted in somnolence, agitation, and seizures.
• B. Agitation, insomnia, headache, dizziness, somnolence, and fatigue are among the most frequently reported adverse effects of sertraline.
• C. Other therapeutic side effects include: ataxia, incoordination, vertigo, abnormal dreams, aggressive behavior, delusions, tremor, hallucinations, emotional lability, paranoia, suicidal ideation, akathisia, tingling, feelings of panic, insomnia, extrapyramidal symptoms, dystonia, exacerbation of tics, mania, and depersonalization.
• 0.2.8 GASTROINTESTINAL
• A. Infrequently, sertraline has been reported to cause constipation, diarrhea, indigestion, anorexia, flatulence, abdominal pain, and increased appetite.
• B. It may also be associated with eructation, dysphagia, incontinence, gastritis, glossitis, gum hyperplasia, hiccups, stomatitis, tenesmus, and tongue ulceration.
• 0.2.9 HEPATIC
• A. Elevated liver enzymes have been noted occasionally with therapeutic use and following acute overdose.
• 0.2.10 GENITOURINARY
• A. Infrequent reports of dysmenorrhea, intermenstrual bleeding, amenorrhea, menorrhagia, leukorrhea, and atrophic vaginitis have occurred during therapeutic use.
• B. Urinary frequency, dysuria, urinary retention, urinary incontinence, and renal pain have occasionally been associated with sertraline therapy.
• C. Male sexual dysfunction and priapism have been reported following therapeutic use.
• 0.2.12 FLUID-ELECTROLYTE
• A. Hyponatremia secondary to SIADH has been reported following sertraline therapeutic use as well as overdose and has been severe enough to cause seizures.
• 0.2.13 HEMATOLOGIC
• A. Anterior chamber eye hemorrhage and purpura have occurred infrequently with sertraline therapeutic use.
• 0.2.14 DERMATOLOGIC
• A. Various types of dermatitis have been reported with therapeutic use.
• B. Cutaneous vasodilation has been reported following overdose.
• 0.2.15 MUSCULOSKELETAL
• A. Sertraline has been associated with myalgia, arthralgia, dystonia, and muscle weakness.
• B. Elevated creatine phosphokinase (CPK) levels may be seen following an acute overdose.
• 0.2.16 ENDOCRINE
• A. Gynecomastia, galactorrhea, breast pain, and breast enlargement have rarely been reported with sertraline use.
• 0.2.17 METABOLISM
• A. Hypoglycemia, hypercholesterolemia, hypertriglyceridemia, and a small decrease in serum uric acid have been occasionally associated with therapeutic sertraline use.
• 0.2.20 REPRODUCTIVE
• A. Sertraline has been classified as FDA Pregnancy Category B.
• 0.2.21 CARCINOGENICITY
• A. Animal studies have resulted in negative carcinogenicity tests.
• 0.3 LABORATORY/MONITORING
• A. Asymptomatic elevations in serum transaminases have been reported within the first 9 weeks of sertraline treatment and have disappeared promptly upon discontinuation of sertraline.
• B. Sertraline produces a mean 7% decrease in serum uric acid concentrations.
• C. A decreased white count has been seen therapeutically. It has not been reported in overdoses.
• D. The syndrome of inappropriate secretion of antidiuretic hormone with significant hyponatremia, elevated urinary sodium, and decreased serum osmolarity has been reported with sertraline therapy.
• E. Monitor for signs/symptoms of serotonin syndrome and possible seizures.
• 0.4 TREATMENT OVERVIEW
• 0.4.2 ORAL/PARENTERAL EXPOSURE
• A. EMESIS: Ipecac-induced emesis is not recommended because of the potential for CNS depression and seizures.
• B. GASTRIC LAVAGE: Consider after ingestion of a potentially life-threatening amount of poison if it can be performed soon after ingestion (generally within 1 hour). Protect airway by placement in Trendelenburg and left lateral decubitus position or by endotracheal intubation. Control any seizures first.
• 1. CONTRAINDICATIONS: Loss of airway protective reflexes or decreased level of consciousness in unintubated patients; following ingestion of corrosives; hydrocarbons (high aspiration potential); patients at risk of hemorrhage or gastrointestinal perforation; and trivial or non-toxic ingestion.
• C. ACTIVATED CHARCOAL: Administer charcoal as slurry (240 mL water/30 g charcoal). Usual dose: 25 to 100 g in adults/adolescents, 25 to 50 g in children (1 to 12 years), and 1 g/kg in infants less than 1 year old.
• D. SEIZURES: Administer a benzodiazepine IV; DIAZEPAM (ADULT: 5 to 10 mg, repeat every 10 to 15 min as needed. CHILD: 0.2 to 0.5 mg/kg, repeat every 5 min as needed) or LORAZEPAM (ADULT: 4 to 8 mg; CHILD: 0.05 to 0.1 mg/kg).
• 1. Consider phenobarbital if seizures recur after diazepam 30 mg (adults) or 10 mg (children > 5 years).
• 2. Monitor for hypotension, dysrhythmias, respiratory depression, and need for endotracheal intubation. Evaluate for hypoglycemia, electrolyte disturbances, hypoxia.
• 0.5 RANGE OF TOXICITY
• A. Minimum lethal human exposure is unknown.
• B. Overdoses in adults of 700 to 2100 milligrams have not resulted in serious symptoms. Ingestion of 4 grams resulted in seizures in an adolescent.
• C. Overdose of 400 and 500 milligrams in two children has resulted in serotonin syndrome.
• 1.0 SUBSTANCES INCLUDED/SYNONYMS
• 1.1 THERAPEUTIC/TOXIC CLASS
• A. Sertraline is a naphthylamine derivative that is a serotonin reuptake inhibitor used as an antidepressant.
• 1.2 SPECIFIC SUBSTANCES

o             Sertraline

o             CP-51974-1

• 1.6 AVAILABLE FORMS/SOURCES
• A. ORAL DOSING FORM: ZOLOFT(R) (Roerig)
• 1. Tablet - 50 mg (capsular shaped, light blue, scored; imprint - Zoloft(front), 50 mg(back))
• 2. Tablet - 100 mg (capsular shaped, light yellow, scored; imprint - Zoloft(front), 100 mg(back))
• B. TRADE NAMES IN OTHER COUNTRIES: Trade names for sertraline in other countries include Lustral(R).
• C. MANUFACTURER INFORMATION: ROERIG DIVISION, Pfizer Laboratories Inc, 235 East 42nd Street, New York, NY 10017, (212) 573-7723.
• 3.0 CLINICAL EFFECTS
• 3.1 SUMMARY OF EXPOSURE
• A. Serious toxicity has not been reported with known overdoses of sertraline between 700 and 2100 mg. Patients should be monitored for potential cardiovascular, gastrointestinal, or hepatic abnormalities. Few serious sequelae were reported in overdose cases. Seizures have been reported rarely. Serotonin syndrome may result following significant overdose.
• B. PEDIATRIC - Prolonged tachycardia, hypertension, hallucinations, coma, hyperthermia, tremors, and vasodilation have been reported in a pediatric overdose.
• 3.3 VITAL SIGNS
• 3.3.1 SUMMARY
• A. Hyperthermia, tachycardia, bradycardia, and hypertension have been reported in an acute overdose.
• 3.3.3 TEMPERATURE
• A. CASE REPORT - Hyperthermia has been reported in a pediatric toxic ingestion of sertraline. Two hours post-ingestion a 9-year-old male presented with an oral temperature of 38.5 degrees centigrade. He was transferred to an intensive care unit due to persistent symptoms, which included a rectal temperature of 42.2 degrees centigrade (Kaminski et al, 1994).
• 3.3.4 BLOOD PRESSURE
• A. Hypotension has occurred following an acute overdose of sertraline (Kaminski et al, 1994).
• 3.3.5 PULSE
• A. Increased pulse rate was seen in a pediatric overdose. A heart rate of greater than 200 beats/minute was observed (Kaminski et al, 1994).
• 3.4 HEENT
• 3.4.1 SUMMARY
• A. Sertraline has caused exophthalmos, xerophthalmia, blurred vision, diplopia, photophobia, tearing, conjunctivitis, eye pain, and mydriasis when used therapeutically.
• 3.4.3 EYES
• A. Sertraline has caused exophthalmos, xerophthalmia, blurred vision, diplopia, photophobia, tearing, conjunctivitis, eye pain, and mydriasis (Prod Info Zoloft(R), 1992).
• 3.5 CARDIOVASCULAR
• 3.5.1 SUMMARY
• A. Therapeutic use of sertraline has been associated with palpitations, chest pain, hypertension, hypotension, edema, peripheral ischemia, syncope, and tachycardia.
• B. Overdose of sertraline has been associated with tachycardia, hypertension, and palpitations in a pediatric case.
• 3.5.2 CLINICAL EFFECTS
• A. SUMMARY
• 1. THERAPEUTIC DOSE - Sertraline has been associated with palpitations, chest pain, hypertension, hypotension, edema, peripheral ischemia, syncope, and tachycardia (Prod Info Zoloft(R), 1992).
• B. ECG ABNORMAL
• 1. Electrocardiographic abnormalities were reported in 2 of 8 patients taking sertraline 200 mg daily for 7 weeks (Amin et al, 1989).
• a. One patient developed T-wave flattening, and one developed clinically significant Q-T internal prolongation.
• b. This was the only report in the literature in which such abnormalities were mentioned; additional data are necessary to establish a causal relationship.
• C. TACHYCARDIA
• 1. Mild sinus tachycardia was reported in 4 of 6 adult cases of overdose (Kassner & Woolf, 1992). Hypertension and prolonged tachycardia with a heart rate of greater than 200 beats/minute was seen in a pediatric sertraline overdose (Kaminski et al, 1994).
• 2. CASE REPORT - Following an intentional overdose of sertraline 4000 mg and naproxen 7700 mg, a 14-year-old girl experienced delayed onset seizures 4.5 hours post-ingestion, followed by sustained sinus tachycardia (102-108 bpm). The patient recovered and was discharged to psychiatric care 2 days later (Meier & Lam, 1998).
• 3. CASE REPORT - Severe sinus tachycardia (pulse greater than 170 beats/minute) was reported after overdose in 2 adolescent girls (Mordel & Linden, 1998).
• 3.5.3 ANIMAL EFFECTS
• A. LACK OF EFFECT
• 1. When tested in the dog, doses of 0.1, 0.4, and 1 mg/kg intravenously caused little or no cardiovascular effect (Koe et al, 1983a).
• 3.6 RESPIRATORY
• 3.6.1 SUMMARY
• A. Bronchospasm, dyspnea, cough, and hyperventilation have occasionally been associated with sertraline.
• 3.6.2 CLINICAL EFFECTS
• A. BRONCHOSPASM
• 1. THERAPEUTIC DOSE - Rhinitis, pharyngitis, bronchospasm, dyspnea, cough, and hyperventilation have occasionally been associated with sertraline (Prod Info Zoloft(R), 1992).
• 2. OVERDOSE - Death due to asthma exacerbation was reported in an 18-year-old female following a sertraline overdose (blood concentration 620 ng/mL). The authors suggest that in a variant of the serotonin syndrome, a large dose of a selective serotonin reuptake inhibitor can help precipitate an asthma attack or prevent the patient from being aware of the evolution of an exacerbation (Carson et al, 2000).
• B. HYPERVENTILATION
• 1. Increased respiratory rate has been associated with a sertraline overdose in a pediatric patient (Kaminiski et al, 1994).
• 3.7 NEUROLOGIC
• 3.7.1 SUMMARY
• A. Overdoses have resulted in somnolence, agitation, and seizures.
• B. Agitation, insomnia, headache, dizziness, somnolence, and fatigue are among the most frequently reported adverse effects of sertraline.
• C. Other therapeutic side effects include: ataxia, incoordination, vertigo, abnormal dreams, aggressive behavior, delusions, tremor, hallucinations, emotional lability, paranoia, suicidal ideation, akathisia, tingling, feelings of panic, insomnia, extrapyramidal symptoms, dystonia, exacerbation of tics, mania, and depersonalization.
• 3.7.2 CLINICAL EFFECTS
• A. AGITATION
• 1. CASE REPORTS - Extreme agitation leading to insomnia was seen in a 15-month-old who ingested up to 200 mg (Pers Comm., 1992). Extreme agitation exhibited by hand biting, uncooperativeness, and hostility was seen in a 9-year-old patient following an acute overdose (Kaminiski et al, 1994).
• B. SEIZURES
• 1. Severe sertraline toxicity may rarely result in seizures. In one case, a delayed onset of seizures was reported.
• a. CASE REPORT - A delayed grand mal seizure, occurring 4.5 hours following an overdose of 4000 mg sertraline and 7700 mg naproxen, was reported in a 14-year-old girl. A second seizure occurred 5.5 hours post-ingestion. Serum sertraline serum level of >1000 ng/mL (normal 16-78 ng/mL) and no anion gap was reported on serum chemistry. The girl was discharged to psychiatric care 2 days later (Meier & Lam, 1998).
• C. SOMNOLENCE
• 1. Lethargy was reported in 6 of 6 adult overdoses (Kassner & Woolf, 1992).
• D. PSYCHOMOTOR IMPAIRMENT
• 1. Mattila et al (1988) evaluated the acute effects of single doses of sertraline 100 milligrams, amitriptyline 50 mg, and placebo on psychomotor performance in 12 subjects over 50 years of age in a double-blind, placebo-controlled crossover study.
• a. While performance was clearly impaired by amitriptyline, sertraline caused no significant impairment. In addition, sertraline slightly improved objective measures of alertness.
• b. Although subjective drowsiness was reported with both drugs, the effect was less with sertraline.
• 2. Hindmarch & Bhatti (1988) observed increases in objective measurements of alertness with sertraline in doses of 50, 75, and 100 milligrams in a double-blind, placebo-controlled study.
• a. Cognitive function tests (critical flicker fusion and choice reaction time tests) were performed on 10 patients after single doses. Measurement parameters were significantly improved compared to placebo from 3 to 7.5 hours post-dosing.
• b. However, subjective drowsiness was reported with these doses.
• 3. Saletu et al (1986) reported that higher doses of sertraline (200 to 400 milligrams) may impair psychometric performance.
• a. Extrapyramidal effects including jaw stiffness, torticollis responsive to treatment with diphenhydramine, and akathisia have been reported (Shihabuddin & Rapport, 1994).
• b. Exacerbation of tics in a patient with Tourrette's Syndrome that responded to cessation of sertraline use have been reported (Hauser & Zesiewicz, 1995).
• E. MANIC REACTION
• 1. CASE REPORTS - Laporta et al (1987) reported two cases of hypomania, one occurring after 5 weeks of sertraline 200 mg/day, and one after 100 mg/day for 9 weeks.
• a. In both cases, symptoms resolved upon discontinuation of sertraline and treatment with short-term clonazepam or lithium.
• F. CNS EFFECTS
• 1. Saletu et al (1986) reported anxiety, giddiness, and restlessness with single 200 and 400 mg doses of sertraline.
• 2. Agitation, insomnia, headache, dizziness, somnolence, and fatigue are among the most frequently reported adverse effects of sertraline.
• 3. Other effects include: ataxia, incoordination, vertigo, abnormal dreams, aggressive behavior, delusions, hallucinations, emotional lability, paranoia, suicidal ideation, akathisia tingling, feelings of panic, and depersonalization (Prod Info Zoloft(R), 1992; Reimherr et al, 1990).
• a. A pediatric patient presented with hallucinations as well as extreme psychomotor agitation following an acute overdose. His pupils were fixed and dilated and slowly reactive to light. Deep tendon reflexes were 3+ (Kaminski et al, 1994).
• 4. Tandan et al (1997) report 3 patients with neurally mediated syncope which was exacerbated following the use of sertraline.
• 5. Complex, colorful visual hallucinations have been reported less than 3 weeks after initiation of sertraline therapy in a 38-year-old male. Hallucinations were present daily for 30 to 40 seconds after awakening and resolved following discontinuation of sertraline (Bourgeois et al, 1998).
• G. TREMOR
• 1. Saletu et al (1986) reported tremor as an adverse effect of sertraline with single doses of 200 and 400 milligrams.
• 2. Sertraline has been associated with hypertonia, myalgia, paresthesias, and muscle twitching on rare occasions (Prod Info Zoloft(R), 1992).
• a. Tonic shaking activity in all extremities became intense over several hours in a pediatric patient following an acute overdose. On the third hospital day a mild tremor was still present (Kaminiski et al, 1994).
• H. DYSTONIA
• 1. Extrapyramidal effects including jaw stiffness, torticollis responsive to treatment with diphenhydramine, and akathisia have been reported (Shihabuddin & Rapport, 1994).
• 2. Extrapyramidal effects, including dystonic reactions may occur following therapeutic doses. Stanislav & Childs (1999) reported a painful upper lip dystonia following daily sertraline (50 mg) for 6 months in an adult. The dystonic reaction resolved on discontinuation of sertraline, but resumed on drug re-challenge.
• 3. Reversible Parkinsonism has been reported in a 90-year-old male following several months of sertraline therapy (with dose increased to 150 mg/day 2 weeks prior to onset of extrapyramidal effects). Sertraline was tapered down over 2 weeks to 50 mg/day with complete reversal of Parkinsonism (Schechter & Nunes, 1997).
• I. SEROTONIN SYNDROME
• 1. Sertraline, a selective serotonin reuptake inhibitor, is capable, as other drugs in this class, of inducing a serotonin syndrome. Most often, this syndrome is induced by concurrent use of 2 or more drugs capable of enhancing CNS serotonin activity. Often, patients with serotonin syndrome will respond to discontinuation of sertraline and supportive care alone (Lane & Baldwin, 1997; Horowitz & Mullins, 1999).
• 2. CASE REPORT - Clinical signs suggestive of serotonin syndrome were exhibited in a pediatric overdose case. The patient presented with agitation, delirium, tachycardia, skin flushing, chills, tremor, myoclonus, fever, and elevated CPK levels. The child responded to physostigmine infusion (total dose of 2 mg) with an appropriate reduction of heart rate and temperature (Kaminski et al, 1994).
• 3. CASE REPORT - Serotonin syndrome was reported in a 5-year-old girl 4 hours following the ingestion of at least 400 mg sertraline. On admission to the ED, she was febrile (temperature 39.1 degrees C), diaphoretic, tachycardic (heart rate 177 beats/min) hypertensive (blood pressure 158/90 mmHg) and tachypneic (24 breaths/min).
• a. Three days after the ingestion, her serum sertraline level was 99 ng/mL, which decreased to 14 ng/mL 5 days later. During the week following the ingestion, the child experienced intermittent fevers, mild tachycardia, mild hypertension, mood swings, hyperactivity and impulsive behavior. Symptoms resolved over 7 days, and she was discharged to her mother's care. Sertraline- induced serotonin syndrome was diagnosed (Pao & Tipnis, 1997).
• 4. CASE REPORT - Serotonin syndrome (dilated pupils, hyperactivity, hyperreflexia, unsteady ataxic gait, tremor, fever) was reported in a 24-month-old female 12 hours after an ingestion of 10 50-mg tablets (500 mg) of sertraline. No other medications were ingested. Symptoms resolved 40 minutes after one dose of cyproheptadine 1 mg orally (Horowitz & Mullins, 1999).
• 3.7.3 ANIMAL EFFECTS
• A. SEIZURES
• 1. DOGS - Seizures were reported in single lethal high dose (80 mg/kg) animal studies in dogs that died on the first day of dosing (Davies & Klowe, 1998). In the same study, mice and rats exhibited hyperactivity following high dose sertraline.
• 3.8 GASTROINTESTINAL
• 3.8.1 SUMMARY
• A. Infrequently, sertraline has been reported to cause constipation, diarrhea, indigestion, anorexia, flatulence, abdominal pain, and increased appetite.
• B. It may also be associated with eructation, dysphagia, incontinence, gastritis, glossitis, gum hyperplasia, hiccups, stomatitis, tenesmus, and tongue ulceration.
• 3.8.2 CLINICAL EFFECTS
• A. SUMMARY
• 1. Infrequently, sertraline has been reported to cause constipation, indigestion, anorexia, flatulence, abdominal pain, and increased appetite (Cohn et al, 1990).
• 2. It may also be associated with eructation, dysphagia, incontinence, gastritis, glossitis, gum hyperplasia, hiccups, stomatitis, tenesmus, and tongue ulceration (Prod Info Zoloft(R), 1992).
• B. DIARRHEA
• 1. Diarrhea has been reported with sertraline doses of 200 and 400 mg (Saletu et al, 1986; Reimherr et al, 1990). Intestinal motility was increased by excess serotonin.
• 2. CASE REPORT - Brown & Kerr (1994) reported a case of intentional overdose of 2 grams sertraline in conjunction with alcohol in a 42-year-old female. Her hospital course was uneventful with the exception of diarrhea, without bleeding, which persisted for 12 hours, which may have been exacerbated by sorbitol mixed with activated charcoal.
• C. MOUTH DRY
• 1. Several studies have reported xerostomia as an occasional adverse effect of sertraline in therapeutic doses (Mattila et al, 1988; Reimherr et al, 1988; Amin et al, 1989).
• D. VOMITING
• 1. Mild nausea and vomiting were noted 4 to 6 hours after single doses of 100 mg in one study, and were reported as a frequent side effect in another (Mattila et al, 1988; Reimherr et al, 1990).
• 2. Vomiting occurred in a pediatric overdose of sertraline (Kaminski et al, 1994).
• 3.8.3 ANIMAL EFFECTS
• A. SALIVA INCREASED
• 1. RATS - Marked salivation was reported in rats administered high dose sertraline orally (Davies & Klowe, 1998).
• 3.9 HEPATIC
• 3.9.1 SUMMARY
• A. Elevated liver enzymes have been noted occasionally with therapeutic use and following acute overdose.
• 3.9.2 CLINICAL EFFECTS
• A. HEPATIC ENZYMES INCREASED
• 1. Asymptomatic elevations in serum transaminases have been reported within the first 9 weeks of sertraline treatment and have disappeared promptly upon discontinuation of the drug (Prod Info Zoloft(R), 1992).
• 2. CASE REPORT - Elevated LDH, AST, and ALT levels were reported in a pediatric patient following an acute overdose. On the third hospital day, LDH was 862 U/L, AST 260 U/L, and ALT 198 U/L (Kaminski et al, 1994).
• 3.9.3 ANIMAL EFFECTS
• A. HEPATOCELLULAR DAMAGE
• 1. Toxicity studies in the mouse, rat and dog revealed the liver as the target organ for sertraline toxicity. At maximum tolerated doses, liver findings appeared to be consistent for hepatic xenobiotic-metabolizing enzyme induction. Findings included hepatomegaly, hepatocellular hypertrophy, increased serum transaminase activity and proliferation of smooth endoplasmic reticulum. Hepatic steatosis was seen in mice and rats (Davies & Klowe, 1998).
• 3.10 GENITOURINARY
• 3.10.1 SUMMARY
• A. Infrequent reports of dysmenorrhea, intermenstrual bleeding, amenorrhea, menorrhagia, leukorrhea, and atrophic vaginitis have occurred during therapeutic use.
• B. Urinary frequency, dysuria, urinary retention, urinary incontinence, and renal pain have occasionally been associated with sertraline therapy.
• C. Male sexual dysfunction and priapism have been reported following therapeutic use.
• 3.10.2 CLINICAL EFFECTS
• A. SUMMARY
• 1. Infrequent reports of dysmenorrhea, intermenstrual bleeding, amenorrhea, menorrhagia, leukorrhea, and atrophic vaginitis have occurred with therapy (Prod Info Zoloft(R), 1992).
• 2. Urinary frequency, dysuria, urinary retention, urinary incontinence, and renal pain have occasionally been associated with sertraline therapy (Prod Info Zoloft(R), 1992).
• B. SEXUAL FUNCTION ABNORMAL
• 1. Male sexual dysfunction, primarily delayed ejaculation, has been said to occur significantly more frequently with sertraline than with placebo (Doogan & Caillard, 1988).
• C. PRIAPISM
• 1. Therapeutic use of sertraline, 200 mg/day, resulted in intermittent priapism in a 47-year-old man. Spontaneous resolution occurred after tapering the patient off sertraline. The patient was started on nefazodone treatment with no further episodes of priapism (Rand, 1998).
• 3.12 FLUID-ELECTROLYTE
• 3.12.1 SUMMARY
• A. Hyponatremia secondary to SIADH has been reported following sertraline therapeutic use as well as overdose and has been severe enough to cause seizures.
• 3.12.2 CLINICAL EFFECTS
• A. ANTIDIURETIC HORMONE DISORDER
• 1. Hyponatremia secondary to SIADH has been reported following both therapeutic use and overdose with sertraline. This effect has been reported with all of the selective serotonin reuptake inhibitors, but appears most frequently in patients over 65 years of age (Leung & Remick, 1995; Doshi & Borison, 1994; Llorente et al, 1994; Crews et al, 1993; Thornton & Resch, 1995; Jackson et al, 1995; Pecora et al, 1997).