Pronunciation:

SER-tra-leen

Brand Names:

• Zoloft

Dosage Forms:

• Tablet
• Solution
• Capsule

Warnings:

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Serotonin Reuptake Inhibitor

Uses of This Medicine:

Sertraline is used to treat depression, obsessive-compulsive disorder (OCD), panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD).

Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). It works by increasing the activity of a chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sertraline in children with depression, panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD), and in children younger than 6 years of age with obsessive-compulsive disorder. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sertraline in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), age-related kidney, liver, or heart problems which may require caution and an adjustment in the dose for patients receiving sertraline.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Bromopride
• Cisapride
• Dronedarone
• Eliglustat
• Furazolidone
• Iproniazid
• Isocarboxazid
• Levoketoconazole
• Linezolid
• Mesoridazine
• Methylene Blue
• Metoclopramide
• Ozanimod
• Phenelzine
• Pimozide
• Piperaquine
• Procarbazine
• Rasagiline
• Safinamide
• Saquinavir
• Selegiline
• Sparfloxacin
• Terfenadine
• Thioridazine
• Toloxatone
• Tranylcypromine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Adagrasib
• Alfentanil
• Alfuzosin
• Almotriptan
• Amineptine
• Amiodarone
• Amisulpride
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apixaban
• Apomorphine
• Ardeparin
• Argatroban
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Aspirin
• Astemizole
• Atazanavir
• Atomoxetine
• Azithromycin
• Bedaquiline
• Bemiparin
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Bupropion
• Buserelin
• Buspirone
• Butorphanol
• Cangrelor
• Carbamazepine
• Carvedilol
• Celecoxib
• Ceritinib
• Certoparin
• Chloroquine
• Chlorpheniramine
• Chlorpromazine
• Choline Salicylate
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clonixin
• Clopidogrel
• Clothiapine
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Crizotinib
• Cyclobenzaprine
• Dabigatran Etexilate
• Dabrafenib
• Dalteparin
• Danaparoid
• Darunavir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Desirudin
• Deslorelin
• Desmopressin
• Desvenlafaxine
• Deutetrabenazine
• Dexfenfluramine
• Dexibuprofen
• Dexketoprofen
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodeine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Dothiepin
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Droxicam
• Duloxetine
• Ebastine
• Edoxaban
• Efavirenz
• Eletriptan
• Encainide
• Encorafenib
• Enoxaparin
• Entrectinib
• Epoprostenol
• Eptifibatide
• Eribulin
• Erythromycin
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Etrasimod
• Famotidine
• Felbamate
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Frovatriptan
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Heparin
• Histrelin
• Hydrocodone
• Hydromorphone
• Hydroquinidine
• Hydroxychloroquine
• Hydroxytryptophan
• Hydroxyzine
• Ibuprofen
• Ibutilide
• Iloperidone
• Iloprost
• Imipramine
• Indomethacin
• Inotuzumab Ozogamicin
• Iobenguane I 123
• Iobenguane I 131
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketobemidone
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lasmiditan
• Lefamulin
• Lenvatinib
• Lepirudin
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumefantrine
• Lumiracoxib
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Mefloquine
• Melitracen
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methotrimeprazine
• Methoxyphenamine
• Methylphenidate
• Metoprolol
• Metronidazole
• Mexiletine
• Mifepristone
• Milnacipran
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nabumetone
• Nadroparin
• Nafarelin
• Nalbuphine
• Naproxen
• Naratriptan
• Nebivolol
• Nefazodone
• Nelfinavir
• Nepafenac
• Nicergoline
• Nicomorphine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Oliceridine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxaprozin
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Pacritinib
• Paliperidone
• Palonosetron
• Panobinostat
• Papaveretum
• Papaverine
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Pentazocine
• Perphenazine
• Phenindione
• Phenobarbital
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Pimavanserin
• Pipamperone
• Piritramide
• Piroxicam
• Pitolisant
• Ponesimod
• Posaconazole
• Prajmaline
• Pranoprofen
• Prasugrel
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Proglumetacin
• Promethazine
• Propafenone
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Remifentanil
• Reviparin
• Ribociclib
• Risperidone
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selexipag
• Selpercatinib
• Sertindole
• Sevoflurane
• Sibutramine
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sodium Salicylate
• Solifenacin
• Sorafenib
• Sotalol
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Sulpiride
• Sultopride
• Sumatriptan
• Sunitinib
• Tacrolimus
• Tamoxifen
• Tamsulosin
• Tapentadol
• Telaprevir
• Telavancin
• Telithromycin
• Tenoxicam
• Tetrabenazine
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Timolol
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Tolperisone
• Tolterodine
• Toremifene
• Tramadol
• Trazodone
• Treprostinil
• Triclabendazole
• Trimipramine
• Triptorelin
• Tropisetron
• Tryptophan
• Valdecoxib
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vernakalant
• Vilanterol
• Vilazodone
• Vinflunine
• Voclosporin
• Vorapaxar
• Voriconazole
• Vorinostat
• Vortioxetine
• Warfarin
• Yohimbine
• Zolmitriptan
• Zolpidem
• Zotepine
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Cimetidine
• Fluphenazine
• Ginkgo
• Lamotrigine
• Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Bleeding problems or
• Diabetes or
• Glaucoma, angle-closure, or history of or
• Heart rhythm problems (eg, QT prolongation) or
• Hyponatremia (low sodium in the blood) or
• Mania or hypomania, history of or
• Purpura (purplish or brownish-red discoloration of the skin), history of or
• Seizures, history of—Use with caution. May make these conditions worse.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.

The tablets may be taken with or without food.

If you are taking the oral liquid, use the dropper provided to measure your dose and mix it with 1/2 cup (4 ounces) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Do not mix this medicine with any other liquid. Drink it right away after mixing. Do not mix the medicine with the liquid until you are ready to take your dose. It is okay if the mixture looks hazy.

You may have to take this medicine for several months before you begin to feel better.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution or tablets):
  • For depression:
    • Adults—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For obsessive-compulsive disorder:
    • Adults and teenagers—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children 6 to 12 years of age—At first, 25 mg once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For panic disorder, posttraumatic stress disorder, or social anxiety disorder:
    • Adults—At first, 25 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 200 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For premenstrual dysphoric disorder:
    • Adults—At first, 50 milligrams (mg) once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day throughout your menstrual cycle or 100 mg per day if you are only taking it during your premenstrual time.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits. This is to allow for changes in your dose and to help reduce any side effects. Blood tests may be needed to check for unwanted effects.

Do not take sertraline with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking sertraline during the 14 days after you stop a MAO inhibitor and wait 14 days after stopping sertraline before you start taking a MAO inhibitor. If you take them together or do not wait 14 days, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Do not use pimozide (Orap®) while you are taking this medicine. Do not use the oral liquid form of sertraline if you are also using disulfiram (Antabuse®). Using these medicines together can cause serious problems.

Sertraline may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use sertraline with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St John's wort, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with sertraline.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Sertraline may increase your risk for bleeding problems. Make sure your doctor knows if you or your child are also using other medicines that thin the blood, including NSAIDs (eg, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or warfarin (Coumadin®, Jantoven®).

This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you or your child have headache, trouble concentrating, memory problems, confusion, weakness, or unsteadiness.

Check with your doctor right away if you have chest pain or discomfort, fainting, irregular or slow heart rate, or trouble breathing. These may be symptoms of heart rhythm problems, including QT prolongation and torsades de pointes.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have and orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, talk with your doctor.

The use of alcohol is not recommended in patients who are taking sertraline. .

This medicine may cause some people to become drowsy, to have trouble thinking, or to have problems with movement. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

The dropper dispenser for the oral liquid contains dry natural rubber (a derivative of latex). This may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child have a latex allergy before you start using this medicine.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects including agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Decreased interest in sexual intercourse

failure to discharge semen (in men)

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Less common or rare

Aggressive reaction

breast tenderness or enlargement

confusion

diarrhea

drowsiness

dryness of the mouth

fast talking and excited feelings or actions that are out of control

fever

inability to sit still

increase in body movements

increased sweating

increased thirst

lack of energy

loss of bladder control

mood or behavior changes

muscle spasm or jerking of all extremities

nosebleeds

overactive reflexes

racing heartbeat

red or purple spots on the skin

restlessness

seizures

shivering

skin rash, hives, or itching

sudden loss of consciousness

unusual or sudden body or facial movements or postures

unusual secretion of milk (in females)

Incidence not known

Bleeding gums

blindness

blistering, peeling, or loosening of the skin

bloating

blood in the urine

bloody, black, or tarry stools

blue-yellow color blindness

blurred vision

chest pain, discomfort, or tightness

chills

clay-colored stools

cough or hoarseness

darkened urine

decreased urine output

decreased vision

delayed or inability to have an orgasm

depressed mood

difficulty with breathing

difficulty with speaking

difficulty with swallowing

drooling

dry skin and hair

eye pain

fainting

feeling cold

feeling of discomfort

feeling, seeing, or hearing things that are not there

general feeling of discomfort, illness, tiredness, or weakness

hair loss

high fever

high or low blood pressure

hoarseness or husky voice

hostility

increased clotting times

indigestion

inflamed joints

irritability

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

lightheadedness

loss of appetite

loss of balance control

loss of bladder control

lower back or side pain

muscle aches

muscle cramps and stiffness

muscle trembling, jerking, or stiffness

muscle twitching

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

rash

red, irritated eyes

red, sore, or itching skin

right upper stomach pain and fullness

severe mood or mental changes

severe muscle stiffness

shuffling walk

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sores, welting, or blisters

stiffness of the limbs

stomach pain

sweating

swelling of the face, ankles, or hands

swollen or painful glands

talking or acting with excitement you cannot control

trouble breathing

twisting movements of the body

twitching

uncontrolled movements, especially of the face, neck, and back

unexplained bleeding or bruising

unpleasant breath odor

unusual behavior

unusual tiredness or weakness

vomiting of blood

weight gain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

decreased appetite or weight loss

diarrhea or loose stools

heartburn

sleepiness or unusual drowsiness

stomach cramps, gas, or pain

trouble sleeping

Less common

Agitation, anxiety, or nervousness

bladder pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

cloudy urine

constipation

difficult, burning, or painful urination

flushing or redness of the skin, with feeling of warmth or heat

frequent urge to urinate

increased appetite

pain or tenderness around the eyes and cheekbones

stuffy or runny nose

Incidence not known

Decrease in smell

flushed, dry skin

fruit-like breath odor

increased hunger

increased urination

loss of sense of smell

redness or other discoloration of the skin

severe sunburn

swelling of the breasts (in women)

unexplained weight loss

unusual secretion of milk (in women)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.