Sertraline

Important Safety Information — Sertraline

What is it approved for?

Sertraline is FDA-approved to treat major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, posttraumatic stress disorder (PTSD), social anxiety disorder and premenstrual dysphoric disorder (PMDD). In children and adolescents, the only approved use is OCD, for specific ages listed on the label.

Do not use if

• Taking an MAOI antidepressant, or having stopped one within the past 14 days (including linezolid or methylene blue given into a vein)
• Taking pimozide
• Known allergy to sertraline, such as anaphylaxis or angioedema

Before starting, tell your provider if

• Personal or family history of bipolar disorder, mania or hypomania
• Seizures, glaucoma or narrow eye angles, heart rhythm problems or other risk factors for QTc prolongation, low sodium, or liver problems
• Bleeding problems, or use of aspirin, NSAIDs, other antiplatelet medicines, warfarin or other anticoagulants
• Other medicines that affect serotonin: triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines or St. John's wort
• Medicines broken down by CYP2D6 or tightly bound to blood proteins, such as warfarin, because sertraline can change their levels
• Being older, taking diuretics, or being dehydrated, which raise the risk of low sodium
• Pregnancy, plans to become pregnant, or breastfeeding

Serious side effects — get medical help right away

• Serotonin syndrome. A potentially life-threatening reaction, more likely with other serotonin-affecting medicines but possible with sertraline alone. Get help right away for agitation, hallucinations, confusion, a fast heartbeat, high or low blood pressure, sweating or fever, flushing, tremor, muscle stiffness or twitching, loss of coordination, seizures, nausea, vomiting or diarrhea.
• Increased risk of bleeding. Bruising, nosebleeds and more serious bleeding, including in the digestive tract, can occur, especially with aspirin, NSAIDs, other antiplatelet medicines, warfarin or other anticoagulants.
• Manic episodes. In people with bipolar disorder an antidepressant may trigger a manic or mixed episode. Report greatly increased energy, racing thoughts, unusually grand ideas, severe trouble sleeping, reckless behavior, excessive happiness or irritability, or talking more or faster than usual.
• Angle-closure glaucoma. In people with untreated narrow eye angles, antidepressants can trigger an angle-closure attack. Get care right away for eye pain, changes in vision, or swelling or redness in or around the eye.
• Low sodium (hyponatremia). Signs include headache, difficulty concentrating, memory problems, confusion, weakness and unsteadiness that can lead to falls; severe cases can cause hallucinations, fainting, seizures or coma. Older adults, people taking diuretics and people who are dehydrated are at greater risk.
• Seizures and heart rhythm changes. Sertraline is prescribed with caution in people with a seizure disorder. QTc prolongation and dangerous heart rhythms (Torsade de Pointes) have been reported, so tell your provider about any heart rhythm history or medicines that affect heart rhythm.
• Discontinuation symptoms. Do not stop suddenly. Stopping abruptly can cause nausea, sweating, low mood, irritability, agitation, dizziness, electric shock-like sensations, tremor, anxiety, confusion, headache, tiredness, trouble sleeping, ringing in the ears and, rarely, seizures.
• Serious allergic reactions. Anaphylaxis and angioedema have been reported. Get emergency help for swelling of the face, lips, tongue or throat, hives, or trouble breathing.

Common side effects

Common side effects: nausea, diarrhea or loose stools, tremor, indigestion, decreased appetite, increased sweating, ejaculation failure and decreased sexual desire. These are not all the possible side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pregnancy and breastfeeding

Talk with your provider before starting, stopping or changing sertraline during pregnancy, because untreated depression also has risks. Published studies of first-trimester exposure suggest no overall difference in the risk of major birth defects, although some results are inconclusive. The label describes clinical considerations for newborns exposed to SSRIs in the third trimester, and SSRI use in the month before delivery has been associated with a modest increase in the risk of heavy bleeding after birth. Low levels of sertraline pass into breast milk; in a published analysis no adverse reactions were seen in breastfed infants. Tell your provider if you are breastfeeding.

If you are in crisis or thinking about suicide, call or text 988 (Suicide & Crisis Lifeline) or call 911.

Forever Health Rx does not provide crisis or emergency care.

Call your provider right away about new or worse depression, anxiety or panic attacks, agitation, restlessness, anger or irritability, acting aggressive or on dangerous impulses, trouble sleeping, or other unusual changes in mood or behavior.

Sertraline can cause a false-positive result on urine screening tests for benzodiazepines, even for several days after stopping; a confirmatory test can tell them apart.

Prescription only. Sertraline is available only after an online visit with a licensed provider, who determines whether treatment is appropriate for you. This summary does not replace the full prescribing information. Not medical advice. Results may vary.