What is the most important information I should know about sertraline?

Do not take sertraline if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Tell your doctor right away if you become pregnant while taking this medication. Sertaline may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking sertraline during pregnancy without your doctor's advice.

What is sertraline?

Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Sertraline affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Sertraline is used to treat depression, obsessive-compulsive disorder, panic disorder, anxiety disorders, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD).

Sertraline may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sertraline?

Do not use sertraline if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You must wait at least 14 days after stopping an MAO inhibitor before you can take sertraline. After you stop taking sertraline, you must wait at least 14 days before you start taking an MAOI.

To make sure you can safely take sertraline, tell your doctor if you have any of these other conditions:

• liver or kidney disease;
• seizures or epilepsy;
• a bleeding or blood clotting disorder;
• bipolar disorder (manic depression); or
• a history of drug abuse or suicidal thoughts.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. Tell your doctor right away if you become pregnant while taking this medication. Sertraline may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant. Do not start or stop taking sertraline during pregnancy without your doctor's advice.

It is not known whether sertraline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give sertraline to anyone younger than 18 years old without the advice of a doctor. Sertraline is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children.

How should I take sertraline?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Sertraline may be taken with or without food. Try to take the medicine at the same time each day. Follow the directions on your prescription label.

The liquid form of sertraline must be diluted before you take it. To be sure you get the correct dose, measure the liquid with the medicine dropper provided. Mix the dose with 4 ounces (one-half cup) of water, ginger ale, lemon/lime soda, lemonade, or orange juice. Do not use any other liquids to dilute the medicine. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

This medication can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking sertraline.

It may take up to 4 weeks before your symptoms improve. Do not stop using sertraline without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include extreme drowsiness, vomiting, rapid heart rate, agitation, or tremor.

What should I avoid while taking sertraline?

Drinking alcohol can increase certain side effects of sertraline.

Do not take the liquid form of sertraline if you are taking disulfiram (Antabuse). Liquid sertraline may contain alcohol and you could have a severe reaction to the disulfiram.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What are the possible side effects of sertraline?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
• agitation, hallucinations, fever, overactive reflexes, tremors;
• nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
• headache, trouble concentrating, memory problems, weakness, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

• drowsiness, dizziness, tired feeling;
• mild nausea, stomach pain, upset stomach, constipation;
• dry mouth;
• changes in appetite or weight;
• sleep problems (insomnia); or
• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect sertraline?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others. Using an NSAID with sertraline may cause you to bruise or bleed easily.

Before using sertraline, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by sertraline.

Tell your doctor about all other medicines you use, especially:

• cimetidine (Tagamet);
• digitoxin (Crystodigin);
• fentanyl (Abstral, Actiq, Fentora, Duragesic, Ionsys, Lazanda, Onsolis);
• linezolid (Zyvox);
• lithium (Lithobid, Eskalith);
• St. John's wort;
• tramadol (Ultram, Ultram ER, Ultracet);
• 5-hydroxytryptophan (5-HTP);
• valproate (Depacon, Depakene);
• a blood thinner such as warfarin (Coumadin, Jantoven);
• cough and cold medicines;
• any other antidepressant such as amitriptyline (Elavil), bupropion (Wellbutrin), citalopram (Celexa), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), milnacipran (Savella), nortriptyline (Pamelor), paroxetine (Paxil), or venlafaxine (Effexor);
• heart rhythm medication such as flecainide (Tambocor), propafenone (Rhythmol), and others; or
• migraine headache medicine such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig).

This list is not complete and other drugs may interact with sertraline. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about sertraline.