Zoloft Adverse Reactions
Zoloft (Sertraline) Adverse Reactions
- agitation
- akathisia
- anorexia
- anxiety
- asthenia
- bleeding
- blurred vision
- chest pain (unspecified)
- constipation
- diaphoresis
- diarrhea
- dizziness
- drowsiness
- dyspepsia
- ecchymosis
- ejaculation dysfunction
- elevated hepatic enzymes
- emotional lability
- epistaxis
- fatigue
- fever
- flatulence
- flushing
- headache
- hostility
- hyperesthesia
- hyperkinesis
- hyponatremia
- impaired cognition
- impotence
- insomnia
- irritability
- libido decrease
- malaise
- mania
- myalgia
- nausea/vomiting
- orgasm dysfunction
- palpitations
- paresthesias
- platelet dysfunction
- priapism
- purpura
- rash (unspecified)
- rhinitis
- seizures
- serotonin syndrome
- SIADH
- sinusitis
- suicidal ideation
- tinnitus
- tremor
- urinary incontinence
- weakness
- weight gain
- weight loss
- withdrawal
- xerostomia
- yawning
Zoloft (Sertraline) Adverse Reactions
The following adverse events, unless otherwise specified, represent treatment-emergent adverse effects seen with sertraline in all manufacturer-based placebo-controlled trials for depression, obsessive-compulsive disorder (OCD), panic disorder, and post-traumatic stress disorder (PTSD) combined. In pediatric patients treated with sertraline, the overall profile of adverse events in controlled studies was generally similar to that seen in adults, as listed in these overall rates, except where otherwise noted.
Gastrointestinal adverse effects are the most problematic adverse effects of serotonin reuptake inhibitor therapies in routine clinical practice. Nausea/vomiting is the most commonly observed gastrointestinal disorder, occurring in about 27%/4% of patients treated with sertraline, and 13%/2% of patients treated with placebo, respectively. Diarrhea was observed to occur in 21% of patients receiving sertraline versus 11 % of patients on placebo. Both nausea and diarrhea are common reasons for drug discontinuation by patients. The following GI events may also occur with sertraline versus placebo, respectively, at the following incidences: Anorexia (6% versus 2%), constipation (7% versus 5%), dyspepsia (8% versus 4%) and flatulence (4% versus 3%). Elevated hepatic enzymes have been reported in approximately 0.8% of patients during sertraline therapy. Enzyme elevations are typically asymptomatic, usually occurring within the first 1—9 weeks of therapy.
There have been several reports of abnormal bleeding (mostly ecchymosis and purpura) associated with sertraline treatment, including reports of impaired platelet aggregation. While a causal relationship to sertraline has not been established, platelet dysfunction may result from platelet serotonin depletion and may contribute to abnormal bleeding. The following adverse events were reported at an incidence of at least 2% in children and occurred at an incidence at least twice the placebo rate: purpura and epistaxis.
More general treatment emergent adverse events associated with sertraline and occurring at a rate greater than placebo, respectively, included: fatigue (11% versus 7%). Rash (unspecified) was seen in roughly 3% of patients treated with sertraline versus 2% on placebo. Vision abnormalities, mostly reported as blurred vision, occurred in 4% on sertraline vs. 2% on placebo. However, the following additional adverse events, were reported at an incidence of at least 2% in children and occurred at an incidence at least twice the placebo rate: fever, malaise and weight loss.
All effective antidepressants can transform depression into mania in predisposed individuals. During initial clinical trials with sertraline, hypomania or mania occurred in about 0.4% of patients. If mania occurs, the antidepressant should be held and appropriate therapy to treat the manic symptoms initiated.
Autonomic, central, or peripheral nervous system side effects as well as psychiatric-related disorders are fairly common with sertraline. Drowsiness (somnolence) is the most commonly reported CNS effect; sedation occurred in 14% of subjects taking sertraline versus 7% of patients taking placebo. Some nervous-system related effects may diminish with continued therapy. Other events that may occur with sertraline versus placebo, respectively, at the following estimated incidences include: agitation (6% vs. 4%); anxiety (4% vs. 3%); diaphoresis (6% vs. 2%, reported as increased sweating); dizziness (13% vs. 8%); headache (26% vs. 23%); insomnia (22% vs. 11%); nervousness (6% vs. 4%); paresthesias (3% vs. 2%); tremor (9% vs. 2%); vasodilation or flushing, reported as hot flushes (2% vs. 1%); and xerostomia (15% vs. 9%). The following additional adverse events were reported at an incidence of at least 2% in children and occurred at an incidence at least twice the placebo rate: aggressive reaction, hyperkinesis, twitching, impaired cognition or thinking, and emotional lability. Suicidal ideation has been reported in antidepressant clinical trials. The symptoms of aggressiveness, akathisia (psychomotor restlessness), agitation, anxiety, insomnia, irritability, hostility, mania, hypomania, impulsivity, and panic attacks have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidal ideation. A change or discontinuation of the therapeutic regimen should especially be considered if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Many of these adverse symptoms have been reported in clinical trials and have not always been associated with suicidality. Rapid discontinuation of SSRIs may also result in many of these adverse CNS events.
During initial clinical trials, sexual dysfunction manifested primarily as ejaculation dysfunction (ejaculatory delay) and orgasm dysfunction (anorgasmia) was observed in about 14% of men on sertraline versus 1% of patients receiving placebo. Roughly 1% of men on sertraline experience impotence. Libido decrease is reported by roughly 5% of males and females receiving sertraline combined. Roughly 2% of women treated with sertraline experience anorgasmia. Priapism, a medical emergency, has been reported rarely with all of the SSRIs; in those cases with a known outcome, the male patients recovered without sequelae after drug discontinuation and appropriate treatment. However, post-marketing experience has suggested that the frequency of sexual-related adverse events may be higher than those reported in clinical trials. Similar to the experience with other SSRIs, it is possible that a higher incidence of sexual dysfunction will be reported during post-marketing experience with sertraline.
The following adverse events have also been reported to occur in 1% of sertraline treated patients suffering from OCD or major depressive disorder, except those already listed. It is important to emphasize that although the events reported occurred during treatment with sertraline, they were not necessarily caused by it. The following events are listed by body system. Body as a whole: back pain, asthenia/weakness, malaise. Cardiovascular system: palpitations, chest pain (unspecified). Gastrointestinal: increased appetite (polyphagia), weight gain. Central and peripheral nervous system: hypertonia, hyperesthesia. Musculoskeletal: myalgia. Psychiatric: yawning, various forms of sexual dysfunction in males or females, not described. Respiratory: rhinitis. Special senses: tinnitus. NOTE: additional reported infrequent side effects (0.1—1% of patients) and rare events (<= 0.1% of patients) in which a causal relationship to sertraline has not been established are listed in the manufacturer’s prescribing information. Reports of adverse events temporally associated with sertraline that have been received since market introduction, that are not previously listed and that may have no causal relationship with the drug may also be found in the manufacturer’s literature.
During pre-marketing studies with sertraline, seizures occurred in roughly 0.2% of patients. Sertraline should be discontinued in any patient who develops seizures while on sertraline therapy.
A rarely reported adverse reaction associated with use of sertraline is the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). SIADH presents as hyposmolarity of serum and urine, and hyponatremia. Drug-induced SIADH is a potential side effect of any SSRI-type antidepressant. Most cases of hyponatremia were in elderly patients and/or patients on diuretics or who were otherwise volume depleted. This effects appears to be reversible after discontinuation of sertraline.
Discontinuation symptoms have not been systematically evaluated in patients taking sertraline. However, discontinuation symptoms have been reported upon abruptly stopping an SSRI. The most commonly reported withdrawal symptoms include fatigue, abdominal pain or nausea, dizziness/light-headedness, tremor, chills, diaphoresis, and incoordination. Other reported discontinuation symptoms with SSRI-therapy include impaired memory, insomnia, shock sensations, headache, and agitation or aggression. Withdrawal symptoms usually begin 1—3 days after abrupt discontinuation of the SSRI and remit within 1—2 weeks. Gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of withdrawal-like symptoms.
Serotonin syndrome has been reported when SSRIs are administered concomitantly with other medications known to increase CNS or peripheral serotonin levels or during SSRI overdose. Serotonin syndrome is a range of signs and symptoms that can rarely, in its most severe form, resemble neuroleptic malignant syndrome. Symptoms may include nausea/vomiting, sedation, dizziness, diaphoresis (sweating), facial flush, mental status changes, myoclonia, restlessness, shivering, and hypertension. The largest known overdose ingestion was 13.5 grams in a patient who took sertraline alone and subsequently recovered. However, another patient who took 2.5 grams of sertraline alone experienced a fatal outcome. Other important adverse events reported with sertraline hydrochloride overdose (single or multiple drugs) include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence, bradycardia, bundle branch block, coma, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, seizures, stupor and syncope. A drug discontinuation syndrome, resembling serotonin syndrome, has been reported in neonates exposed to SSRIs or SNRIs late in the third trimester.
The following adverse events were reported at an incidence of at least 2% (n=281) in children and occurred at an incidence at least twice the placebo rate: urinary incontinence and sinusitis. Causality due to sertraline is not known.
[ Last revised: 11/9/2005 1:46:00 PM ]
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