Sertraline (Zoloft) Risks, Warnings, and Complications

CLINICAL WORSENING OF DEPRESSION AND SUICIDE RISK: People with major depressive disorder (MDD) and other mental health conditions can develop worsening depression and anxiety symptoms and suicidal thoughts and behaviors on antidepressant medications, including SSRIs such as sertraline, especially during early treatment. The increased risk of suicidal thinking and behavior is highest in children, adolescents, and young adults below 24 years of age who have major depressive disorder (MDD) and other psychiatric conditions. 

Call your healthcare provider immediately if you develop irritability, agitation, anxiety, panic attacks, sleep problems, mood changes such as aggression or hostility, impulsiveness, restlessness, abnormal excitement, and suicidality (suicidal thoughts or behaviors of self-harm). Members of your household should know when and how to seek care if they notice any unusual changes in mood or behavior after you start taking sertraline, especially in the first few months of therapy and after dose changes. 

SCREENING FOR BIPOLAR DISORDER: People with bipolar disorder can initially present with a major depressive episode. Treating bipolar depression with an antidepressant drug such as sertraline can trigger a mixed or manic episode in such individuals. Your healthcare provider will screen you for bipolar illness before they prescribe sertraline. Tell your doctor if you have a personal or family history of bipolar disorder, depression, or suicide attempts. Note that sertraline is not approved for treating bipolar depression.

DRUG INTERACTIONS: There are reports of fatal adverse reactions in people who received sertraline which is a selective serotonin reuptake inhibitor (SSRI) along with a monoamine oxidase inhibitor (MAOI). You should not take sertraline at the same time as an MAOI. You should have stopped taking monoamine oxidase inhibitors for at least 14 days before starting sertraline.

Give your doctor and pharmacist a complete list of all your medications before starting treatment with sertraline. Seek emergency medical care for hyperthermia (elevated body temperature), severe muscle rigidity or twitching, rapid fluctuations in heart rate, low or high blood pressure, and mental status changes such as irritability, agitation, confusion, delirium, or coma. 

SEROTONIN SYNDROME: Sertraline and other SSRIs can lead to the development of a life-threatening condition called serotonin syndrome which occurs due to too much serotonin in the body. The risk is highest in people who are taking other serotonergic drugs such as other antidepressants, migraine medications (triptans), monoamine oxidase inhibitors (MAOIs), or serotonin precursors such as tryptophan, which can also increase serotonin levels. 

Seek emergency medical care for signs and symptoms of serotonin syndrome, such as mental status changes (irritability, agitation, hallucinations), fast heartbeat, rapid changes in blood pressure, elevated body temperature, neuromuscular symptoms, gastrointestinal symptoms (nausea, vomiting, diarrhea), or loss of consciousness.

NEUROLEPTIC MALIGNANT SYNDROME: There are rare reports of neuroleptic malignant syndrome (NMS) or NMS-like reactions in people who received selective serotonin reuptake inhibitors (SSRIs) such as sertraline or serotonin-norepinephrine reuptake inhibitors (SNRIs) along with antipsychotic drugs. A small number of people have developed neuroleptic malignant syndrome even in the absence of antipsychotic drugs. 

NMS is a serious and potentially life-threatening condition with signs and symptoms such as hyperthermia, muscle stiffness, heart rate and blood pressure instability, and mental status changes. Notably, severe serotonin syndrome can resemble neuroleptic malignant syndrome, and both conditions are potentially life-threatening. 

Seek emergency medical attention if you develop signs and symptoms of serotonin syndrome or neuroleptic malignant syndrome.

ANGLE-CLOSURE GLAUCOMA: Sertraline treatment can lead to angle-closure glaucoma, an eye condition in which there is increased pressure in the eye, which can lead to gradual but permanent loss of vision. Seek immediate medical care for eye pain, redness, swelling, or vision changes.