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What is Zoloft?

Zoloft (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.

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

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

Important information about Zoloft

You should not use Zoloft if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use Zoloft if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Zoloft. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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.

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

Before taking Zoloft

You should not use Zoloft if you are allergic to sertraline, if you also take pimozide, or if you are being treated with methylene blue injection.

Do not use Zoloft if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine. After you stop taking Zoloft, you must wait at least 14 days before you start taking an MAOI.

To make sure Zoloft is safe for you, tell your doctor if you have:

  • 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.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using Zoloft. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. Taking an SSRI antidepressant during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant while taking Zoloft. Do not start or stop taking this medicine 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. Tell your doctor if you are breast-feeding a baby.

Do not give Zoloft 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 Zoloft?

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

Zoloft may be taken with or without food. Try to take the medicine at the same time each day.

The liquid form of Zoloft 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 medicine 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 Zoloft.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Zoloft suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using citalopram.

Store Zoloft 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.

What should I avoid while taking Zoloft?

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), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Zoloft may cause you to bruise or bleed easily.

Drinking alcohol can increase certain side effects of Zoloft.

Do not take the liquid form of Zoloft if you are taking disulfiram (Antabuse). Liquid Zoloft 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.

Sertraline side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Zoloft: 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:

  • 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.

Common Zoloft 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.

Zoloft Dosing Information

Usual Adult Dose of Zoloft for Depression:

Initial dose: 50 mg orally once a day.
Increase dose by 50 mg increments no more often than weekly.
Maintenance Dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Obsessive Compulsive Disorder:

Initial dose: 50 mg orally once a day.
Increase dose by 50 mg increments no more often than weekly.
Maintenance Dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose of Zoloft for Panic Disorder:

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Post Traumatic Stress Disorder:

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose of Zoloft for Social Anxiety Disorder:

Initial dose: 25 mg orally once a day, after one week, the dose may be increased to 50 mg once a day. Increase dose by 50 mg increments no more often than weekly.
Maintenance dose: Can increase once a week, to a maximum of 200 mg once a day.

Usual Adult Dose for Premenstrual Dysphoric Disorder:

Initial dose: 50 mg orally once a day, either throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle (depending on the clinical judgement of the physician).

Patients not responding to a 50 mg per day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg per day when dosing daily throughout the menstrual cycle, or 100 mg per day when dosing during the luteal phase of the menstrual cycle. If a 100 mg per day dose is established with luteal phase dosing, a 50 mg per day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

The effectiveness of Zoloft for longer than three months has not been systematically evaluated in controlled trials.

What other drugs will affect Zoloft?

Taking Zoloft with other drugs that make you sleepy or slow your breathing can increase these effects. Ask your doctor before taking Zoloft with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Zoloft, especially:

  • any other antidepressant;

  • buspirone;

  • cimetidine;

  • digitoxin;

  • lithium;

  • St. John's wort;

  • tryptophan (sometimes called L-tryptophan);

  • warfarin, Coumadin;

  • cough medicine that contains dextromethorphan;

  • heart or blood pressure medication--flecainide, metoprolol, propafenone, propranolol, and others;

  • migraine headache medicines--sumatriptan, zolmitriptan, and others;

  • pain medication--fentanyl, tramadol; or

  • seizure medication--divalproex, phenytoin.

This list is not complete. Other drugs may interact with Zoloft, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For the Consumer

Applies to sertraline: oral capsule, oral solution, oral tablet

Along with its needed effects, sertraline (the active ingredient contained in Zoloft) 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 while taking sertraline:

More common
  • Decreased sexual desire or ability
  • failure to discharge semen (in men)
Less common or rare
  • Aggressive reaction
  • breast tenderness or enlargement
  • confusion
  • convulsions
  • diarrhea
  • drowsiness
  • dryness of the mouth
  • fast talking and excited feelings or actions that are out of control
  • fast, pounding, irregular, or slow heartbeat
  • 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
  • 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
  • Abdominal or stomach pain
  • 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 or discomfort
  • chills
  • clay-colored stools
  • cough or hoarseness
  • darkened urine
  • decreased urine output
  • decreased vision
  • 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
  • sweating
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • talking or acting with excitement you cannot control
  • tightness in the chest
  • troubled 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 of sertraline 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 or abdominal 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
  • Flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased urination
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the breasts (in women)
  • unexplained weight loss
  • unusual secretion of milk (in women)

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Applies to sertraline: oral concentrate, oral tablet

Gastrointestinal

Gastrointestinal side effects including nausea are the most common adverse effects caused by sertraline (the active ingredient contained in Zoloft) One report has suggested that as many as 30% of patients treated with sertraline experience nausea, although most other studies have suggested a lower frequency. Other reported gastrointestinal effects include dry mouth (14% to 20%), diarrhea (17%), constipation, upper GI bleeding, and dyspepsia.

There are two cases in the literature in which the use of Lactobacillus acidophilus capsules were reported to have been very helpful in the treatment of persistent, sertraline-induced diarrhea.

A study of 26,005 antidepressant users has reported 3.6 times more upper GI bleeding episodes with the use of SSRIs relative to the population who did not receive antidepressant medications. Upper gastrointestinal tract bleeding was observed in 4.1 times more frequently in patients receiving sertraline.

Nervous system

Although sertraline (the active ingredient contained in Zoloft) usually causes stimulation, cases of sedation in some patients have been reported.

In one case, a patient with an AV malformation in the region of the corpus callosum developed akathisia and a dystonic reaction following a two week exposure to sertraline.

Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.

Nervous system side effects including insomnia, somnolence, tremor, dizziness, headache, and fatigue have all been reported. The incidence of each of these effects ranges between 10% and 20% of treated patients. Akathisia, myoclonic jerking, and sleep abnormalities have also been reported. At higher doses, drowsiness often ensues. Increased alertness and enhanced cognition have been reported when sertraline is taken at low doses. Excitement has been reported less frequently. Sertraline-induced facial paresthesia has also been reported.

Psychiatric

Psychiatric side effects including agitation and changes to hypomania have been observed infrequently. Although the drug has been reported to be an effective agent in the treatment of panic attacks, several cases of sertraline- induced panic attacks have been reported.

General

General side effects including weight loss have been reported frequently.

Genitourinary

Genitourinary side effects including male sexual dysfunction (involving ejaculatory delay, impotence, and decreased libido) have been reported in as many as 21% of treated patients. In a study involving patients receiving sertraline (the active ingredient contained in Zoloft) (50 to 200 mg daily) for the treatment of generalized anxiety disorder, 17% of patients reported a decrease or loss of libido. Among male patients, nearly 18% experienced some type of sexual dysfunction including abnormal orgasm/anorgasmia (10%), ejaculation failure (6%), and erectile disturbance (1.5%).

A single case of priapism has been reported in association with sertraline therapy. The patient was also taking lithium at the time.

Hepatic

Hepatic side effects including reversible elevations in liver function tests have been reported to occur in about 0.5% of treated patients.

Cardiovascular

Cardiovascular side effects including rare cases of hypertension, angina, and arrhythmias have been reported.

Endocrine

Endocrine side effects including two cases of galactorrhea have been reported in association with sertraline (the active ingredient contained in Zoloft) therapy. Two cases of breast discomfort and enlargement without galactorrhea have also been reported.

Case reports have suggested that sertraline, like other serotonin- specific reuptake inhibitors, may induce the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Seven cases of hyponatremia have been reported, four of which were associated with SIADH. Six of the seven patients were over 60 years of age.

Other

Other side effects including a withdrawal syndrome have been reported. In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least one qualitatively new symptom were defined in the sertraline (the active ingredient contained in Zoloft) group at a rate of 1.5%.

Other side effects including speech difficulties (which included stuttering and speech blockage) have been reported. At least one case of sertraline-related night sweats has also been reported.

A case of withdrawal symptoms involving fatigue, abdominal cramps, insomnia, aching and chills has been reported following the abrupt discontinuation of sertraline. In another case, a patient developed dizziness and orthostatic hypotension on repeated attempts to discontinue the drug.

The night sweats stopped within four days of discontinuation of sertraline therapy. When the patient was changed to fluoxetine, the sweating did not recur.

Hematologic

Hematologic side effects including a case of septic shock secondary to agranulocytosis has been reported. A single case report has suggested that sertraline (the active ingredient contained in Zoloft) may improve platelet counts in patients with idiopathic thrombocytopenia purpura.

Ocular

Ocular side effects including "abnormal vision" may occur in some patients according to one report. The specific abnormalities observed were not described by the authors.

Dermatologic

Dermatologic side effects including alopecia (1%) have been reported. A case of photosensitivity has also been reported.

Musculoskeletal

Musculoskeletal side effects may include increased odds of a hip fracture. In one study using the healthcare data from the province of Ontario, Canada reviewing 8,239 patients treated for hip fractures, the adjusted odds ratio for hip fracture was 2.4 for exposure to selective serotonin reuptake inhibitors (including fluoxetine, fluvoxamine, paroxetine, and sertraline (the active ingredient contained in Zoloft) , compared to participants who had no exposure to antidepressants.

Renal

Renal side effects including a mean decrease in serum uric acid levels of approximately 7% have been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported in elderly patients. An increase in serum cholesterol has been reported following use of sertraline (the active ingredient contained in Zoloft)

The results of one study appear to indicate that treatment with selective serotonin reuptake inhibitors (i.e., paroxetine, sertraline, citalopram) may cause an increase in serum total cholesterol, HDL cholesterol, and/or LDL cholesterol. However, additional studies are necessary to confirm these findings.

Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). Risk factors for the development of SSRI- associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.

Respiratory

Respiratory side effects have included upper respiratory tract infection. In a study involving 314 women with moderate to severe premenstrual syndrome, 6% to 10% of patients developed upper respiratory tract infection after receiving sertraline (the active ingredient contained in Zoloft) 25 to 50 mg daily. However, it should be noted that 7% of placebo- treated patients also developed upper respiratory tract infection.