What are the potential complications of sertraline (SSRI)?

From the Guidelines

Sertraline can cause several potential complications, including common side effects such as nausea, diarrhea, and insomnia, as well as more serious complications like suicidal thoughts, serotonin syndrome, and withdrawal symptoms, as noted in the most recent guideline from the Journal of the American Academy of Child and Adolescent Psychiatry 1.

Common Side Effects

• Nausea
• Diarrhea
• Insomnia
• Sexual dysfunction (including decreased libido and delayed orgasm)
• Headache
• Dizziness
• Dry mouth
• Increased sweating These effects often emerge within the first few weeks of treatment and may diminish over time.

Serious Complications

• Increased risk of suicidal thoughts or behaviors, particularly in young adults and adolescents during the initial treatment period
• Serotonin syndrome, a potentially life-threatening condition characterized by agitation, hallucinations, rapid heart rate, fever, excessive sweating, shivering, muscle stiffness, and coordination problems, especially when combined with other serotonergic medications
• Withdrawal symptoms, including dizziness, irritability, headaches, and flu-like symptoms, which can occur with abrupt discontinuation
• Interactions with numerous medications, including NSAIDs, warfarin, and other psychiatric medications, potentially increasing bleeding risk or serotonergic effects
• Rarely, hyponatremia (low sodium levels), particularly in elderly patients, and manic episodes in people with undiagnosed bipolar disorder

Special Considerations

• Sertraline has been associated with discontinuation syndrome, characterized by dizziness, fatigue, lethargy, general malaise, myalgias, chills, headaches, nausea, vomiting, diarrhea, insomnia, imbalance, vertigo, sensory disturbances, paresthesias, anxiety, irritability, and agitation, as reported in a clinical practice guideline from the Journal of the American Academy of Child and Adolescent Psychiatry 1.
• The medication should be started at a low dose and increased slowly, with monitoring for symptoms, especially in the first 24 to 48 hours after dosage changes, as recommended in the guideline from the Journal of the American Academy of Child and Adolescent Psychiatry 1.

From the FDA Drug Label

PRECAUTIONS General Activation of Mania/Hypomania During premarketing testing, hypomania or mania occurred in approximately 0. 4% of sertraline hydrochloride treated patients. Weight Loss Significant weight loss may be an undesirable result of treatment with sertraline for some patients, but on average, patients in controlled trials had minimal, 1 to 2 pound weight loss, versus smaller changes on placebo. Seizure Sertraline has not been evaluated in patients with a seizure disorder. Discontinuation of Treatment with Sertraline During marketing of sertraline and other SSRIs and SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e. g. paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania. Abnormal Bleeding SSRIs and SNRIs, including sertraline, may increase the risk of bleeding events ranging from ecchymoses, hematomas, epistaxis, petechiae, and gastrointestinal hemorrhage to life-threatening hemorrhage.

The potential complications of sertraline (SSRI) include:

• Activation of mania or hypomania in approximately 0.4% of patients
• Weight loss, with significant weight loss being an undesirable result for some patients
• Seizures, particularly in patients with a seizure disorder
• Discontinuation symptoms, such as dysphoric mood, irritability, and anxiety, when treatment is stopped abruptly
• Abnormal bleeding, including ecchymoses, hematomas, and gastrointestinal hemorrhage, due to the increased risk of bleeding events
• Other complications, such as laboratory test abnormalities, including elevations in serum transaminases and changes in total cholesterol and triglycerides 2
• Psychiatric disorders, including yawning, emotional lability, and hallucination 2
• Overdose symptoms, such as somnolence, vomiting, and tachycardia, which can be fatal in some cases 2

From the Research

Potential Complications of Sertraline (SSRI)

The potential complications of sertraline, a selective serotonin reuptake inhibitor (SSRI), include:

• Withdrawal symptoms upon discontinuation, such as dizziness, headache, and nausea 3
• Serotonin syndrome, a rare but potentially life-threatening adverse drug reaction, characterized by symptoms such as hyperreflexia, inducible ankle clonus, and autonomic instability 4
• Gastrointestinal disturbances, headache, sedation, insomnia, activation, weight gain, impaired memory, excessive perspiration, paresthesia, and sexual dysfunction 5
• Increased risk of suicidality in children and young adults aged 18-24, as indicated by a black box warning 6
• Bleeding complications, such as major bleeding, gastrointestinal bleeding, and intracranial hemorrhage, particularly when used concurrently with anticoagulant or antiplatelet agents 7

Specific Complications

Some specific complications associated with sertraline use include:

• Withdrawal syndrome, which can occur within a few days of discontinuation and last for several weeks 3
• Serotonin syndrome, which can be diagnosed using the Hunter criteria and requires immediate medical attention 4
• Bleeding complications, which can be increased when sertraline is used with antithrombotic therapy, such as anticoagulants or antiplatelet agents 7

Risk-Benefit Analysis

When prescribing sertraline, a risk-benefit analysis must be conducted to weigh the potential benefits against the potential risks, including the risk of bleeding complications and increased suicidality in certain populations 6, 7