What is the most important information I should know about sertraline hydrochloride capsules?
Sertraline hydrochloride capsules may cause serious side effects, including:

• Increased risk of suicidal thoughts or actions.
• Sertraline hydrochloride capsules and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

• Depression or other mental illnesses are the most important causes suicidal thoughts or actions.

  attempts to commit suicide

• Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed. 

• Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings or if you or your child develop suicidal thoughts or actions. 

• Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

What are sertraline hydrochloride capsules?

Sertraline hydrochloride capsules are a prescription medicine used to treat:

• A certain type of depression called Major Depressive Disorder (MDD) in adults.
• Obsessive Compulsive Disorder (OCD) in adults and children 6 years and older.
• It is not known if sertraline hydrochloride capsules are safe and effective for use in children under 6 years of age with OCD or children with other behavioral health conditions.

Do not take sertraline hydrochloride capsules if you or your child:

• are taking, or have stopped taking within the last 14 days, a monoamine oxidase inhibitor (MAOI).
• are being treated with the antibiotic linezolid or intravenous methylene blue.
• are taking the antipsychotic medicine pimozide because this can cause serious problems.
• are allergic to sertraline or any of the ingredients in sertraline hydrochloride capsules. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride capsules.

Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI or one of these medicines, including the antibiotic linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with sertraline hydrochloride capsules.

Before taking sertraline hydrochloride capsules, tell your healthcare provider about all medical conditions, including if you or your child:

• have or have had bleeding problems
• have, or have a family history of, bipolar disorder, mania, or hypomania
• have or have had seizures or convulsions
• have high pressure in the eye (glaucoma)
• have low sodium levels in your blood
• have heart problems
• have kidney or liver problems
• have an allergy or sensitivity to FD&C Yellow No. 5 (Tartrazine)
• are pregnant or plan to become pregnant. Sertraline hydrochloride capsules may harm the unborn baby. Taking sertraline hydrochloride capsules during the third trimester of pregnancy may cause the baby to have withdrawal symptoms after birth or may cause the baby to be at an increased risk for a serious lung problem at birth. Talk to your healthcare provider about the risk to the mother and the unborn baby if sertraline hydrochloride capsules are taken during pregnancy.
  • Tell your healthcare provider right away if you or your child becomes pregnant during treatment with sertraline hydrochloride capsules.
• are breastfeeding or plan to breastfeed. Sertraline hydrochloride capsules may pass into breast milk. Talk to your healthcare provider about the best way to feed the baby during treatment with sertraline hydrochloride capsules.

Tell your healthcare provider about all the medicines that you or your child take, including prescription and over- the-counter medicines, vitamins, and herbal supplements.

Sertraline hydrochloride capsules and some medicines may interact with each other causing serious side effects. Sertraline hydrochloride capsules may affect the way other medicines work and other medicines may affect the way sertraline hydrochloride capsules work. Sometimes the doses of other medicines will need to be changed during treatment with sertraline hydrochloride capsules. Your healthcare provider will decide whether sertraline hydrochloride capsules can be taken with other medicines.

Especially tell your healthcare provider if you or your child take:

• medicines used to treat migraine headaches called triptans
• tricyclic antidepressants
• lithium
• tramadol, fentanyl, meperidine, methadone, or other opioids
• tryptophan
• buspirone
• amphetamines
• phenytoin
• St. John's Wort
• medicines that can affect blood clotting such as aspirin, nonsteroidal anti inflammatory drugs (NSAIDs), other antiplatelet medicines, warfarin, and other anticoagulants
• diuretics

Know the medicines you or your child take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take sertraline hydrochloride capsules?

• Take sertraline hydrochloride capsules exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride capsules until it is the right dose.
• Take sertraline hydrochloride capsules with or without food.
• Swallow sertraline hydrochloride capsules whole. Do not open, crush, or chew sertraline hydrochloride capsules.
• If you miss a dose of sertraline hydrochloride capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take 2 doses of sertraline hydrochloride capsules at the same time.
• In case of overdose, get medical help or contact a live Poison Control expert right away at 1-800-222-1222. Advice is also available online at poisonhelp.org.

What are the possible side effects of sertraline hydrochloride capsules?
Sertraline hydrochloride capsules may cause serious side effects, including:

• See, "What is the most important information I should know about sertraline hydrochloride capsules?" 
• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when sertraline hydrochloride capsules are taken with certain other medicines. See, "Who should not take sertraline hydrochloride capsules?" Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome: