A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (‘mood elevators’) such as sertraline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant.

You should know that your mental health may change in unexpected ways when you take sertraline or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; new or worsening anxiety; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking sertraline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with sertraline. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Sertraline is used to treat depression, obsessive-compulsive disorder (bothersome thoughts that won’t go away and the need to perform certain actions over and over), panic attacks (sudden, unexpected attacks of extreme fear and worry about these attacks), posttraumatic stress disorder (disturbing psychological symptoms that develop after a frightening experience), and social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life). It is also used to relieve the symptoms of premenstrual dysphoric disorder, including mood swings, irritability, bloating, and breast tenderness. Sertraline is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amounts of serotonin, a natural substance in the brain that helps maintain mental balance.

Sertraline comes as a tablet and a concentrate (liquid) to take by mouth. It is usually taken once daily in the morning or evening. To treat premenstrual dysphoric disorder, sertraline is taken once a day, either every day of the month or on certain days of the month. Take sertraline at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take sertraline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Sertraline concentrate must be diluted before use. Immediately before taking it, use the provided dropper to remove the amount of concentrate your doctor has told you to take. Mix the concentrate with 4 ounces (1/2 cup [120 milliliters]) of water, ginger ale, lemon or lime soda, lemonade, or orange juice. After mixing, the diluted solution may be hazy; this is normal. Do not mix the concentrate with any liquids other than the ones listed. Drink the diluted solution immediately.

Your doctor may start you on a low dose of sertraline and gradually increase your dose, not more than once a week.

It may take a few weeks or longer before you feel the full benefit of sertraline. Continue to take sertraline even if you feel well. Do not stop taking sertraline without talking to your doctor. If you suddenly stop taking sertraline, you may experience withdrawal symptoms such as nausea, sweating, depression, mood changes, frenzied or abnormally excited mood, irritability, anxiety, confusion, dizziness, headache, tiredness, seizures, ringing in the ears, numbness or tingling in the arms, legs, hands, or feet, difficulty falling asleep or staying asleep.

Sertraline is also used sometimes to treat headaches and sexual problems. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking sertraline,

• Tell your doctor and pharmacist if you are allergic to sertraline, any other medications, any of the ingredients in sertraline preparations, or latex (found in the dropper for the concentrate). Before taking sertraline liquid concentrate, tell your doctor if you are allergic to latex. Ask your pharmacist for a list of the ingredients.
• Tell your doctor if you are taking monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks, or if you are taking pimozide (Orap). Your doctor will probably tell you not to take sertraline. If you stop taking sertraline, you should wait at least 2 weeks before you start to take an MAO inhibitor.
• Do not take disulfiram (Antabuse) while taking sertraline oral concentrate.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); amphetamines; anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven) and heparin; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); atomoxetine (Straterra); buspirone, chlorpromazine; clopidogrel (Plavix), dextromethorphan (found in many cough medications; in Nuedexta); fentanyl (Actiq, Fentora, Lazanda, others), droperidol (Inapsine); erythromycin (E.E.S, Eryc, Ery-tab, others); fosphenytoin (Cerebyx); iloperidone (Fanapt); lithium (Lithobid); medications for anxiety, mental illness, Parkinson’s disease, and seizures; medications for irregular heartbeat such as flecainide and propafenone (Rythmol); metoprolol (Lopressor, Toprol XL); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); mefloquine; methadone (Dolophine, Methadose); moxifloxacin (Avelox); nebivolol (Bystolic, in Byvalson); pentamidine (Nebupent, Pentam); perphenazine; phenytoin (Dilantin, Phenytek); procainamide; quinidine (in Nuedexta); sedatives; sleeping pills; other selective serotonin-reuptake inhibitors such as citalopram (Celexa), fluoxetine (Prozac), or fluvoxamine (Luvox); serotonin–norepinephrine reuptake inhibitors (SNRI) medications such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), levomilnacipran (Fetzima), and venlafaxine; sotalol (Betapace, Sotylize); tacrolimus (Astagraf, Envarsus XR, Prograf); thioridazine; tolterodine (Detrol); tramadol (Conzip, Qdolo, Ultram); tranquilizers; tricyclic antidepressants (‘mood elevators’) such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine; or ziprasidone (Geodon). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sertraline, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor what herbal products and nutritional supplements you are taking, especially St. John’s wort and tryptophan.
• Tell your doctor if you have recently had a heart attack or stroke or if you have high blood pressure, bleeding problems, a low level of sodium in your blood and if you have or have ever had seizures or liver, kidney, or heart disease.
• Tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking sertraline, call your doctor. Sertraline may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
• You should know that sertraline may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• Ask your doctor about the safe use of alcoholic beverages while you are taking sertraline.
• You should know that sertraline may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Sertraline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Nausea
• Diarrhea
• Constipation
• Vomiting
• Difficulty falling asleep or staying asleep
• Dry mouth
• Heartburn
• Loss of appetite
• Weight changes
• Dizziness
• Excessive tiredness
• Headache
• Nervousness
• Uncontrollable shaking of a part of the body
• Sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• Sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm
• Excessive sweating

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately:

• Seizures
• Abnormal bleeding or bruising
• Agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• Headache, weakness, unsteadiness, confusion, or memory problems
• Rash
• Hives
• Swelling
• Difficulty breathing

Sertraline may decrease appetite and cause weight loss in children. Your child’s doctor will watch his or her growth carefully. Talk to your child’s doctor if you have concerns about your child’s growth or weight while he or she is taking this medication. Talk to your child’s doctor about the risks of giving sertraline to your child.

Sertraline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• Drowsiness
• Agitation, hallucinations, fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• Excessive tiredness
• Dizziness
• Agitation
• Mania
• Seizures
• Loss of consciousness
• Dizziness
• Rapid, irregular, or pounding heartbeat

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking sertraline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.