Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Sertraline is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressants compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on sertraline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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sertraline
(SER tra leen)

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 other than those listed in this medication guide.

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What is the price of this medication and similar alternatives?

Pricing information provided by drugstore.com.

Sertraline HCl 100MG TABS GREENSTONE30/$39.99 or 90/$99.96
Sertraline HCl 25MG TABS GREENSTONE30/$31.99 or 90/$87.98
Sertraline HCl 50MG TABS GREENSTONE30/$32.99 or 90/$89.98
Zoloft 20MG/ML CONC PFIZER U.S.60/$81.99 or 180/$234.95

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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.

Call your doctor at once if you have any new or worsening symptoms 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 any of these serious side effects:

  • seizure (convulsions);

  • tremors, shivering, muscle stiffness or twitching;

  • problems with balance or coordination; or

  • agitation, confusion, sweating, fast heartbeat.

Other less serious side effects are more likely to occur, such as:

  • drowsiness, dizziness, weakness;

  • nausea, diarrhea, dry mouth, or changes in appetite or weight; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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How should I take sertraline?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from the medication. Take each tablet with water. 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 oral liquid form of this medicine must be diluted before you take it. To be sure you get the correct dose, measure the liquid with medicine dropper provided, not with a regular table spoon. 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.

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What is the most important information I should know about sertraline?
Do not take sertraline together with pimozide (Orap), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take sertraline. After you stop taking sertraline, you must wait at least 14 days before you start taking an MAOI. You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Sertraline is FDA-approved for children with obsessive-compulsive disorder (OCD). It is not approved for treating depression in children. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

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What other drugs will affect sertraline?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with sertraline may cause you to bruise or bleed easily. Before taking sertraline, tell your doctor if you are using any of the following medicines: tramadol (Ultram, Ultram ER, Ultracet); digitoxin (Crystodigin);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Sertraline has been assigned to pregnancy category C by the FDA. Animal studies have failed to reveal evidence of teratogenicity, but have revealed decreased pup survival related to in utero sertraline exposure in doses up to 4 times the maximum human recommended dose. There are no controlled data in human pregnancy. Neonates exposed to sertraline late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These symptoms are consistent with either a direct toxic effect of SSRIs, a drug discontinuation syndrome, or possible serotonin syndrome. Infants exposed to SSRIs in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). This condition has been associated with substantial neonatal morbidity and mortality. It has not been determined if all SSRIs pose a similar level of PPHN risk. Sertraline is only recommended for use during pregnancy when benefit outweighs risk.

A case of suspected neonatal withdrawal symptoms, secondary to maternal use of sertraline throughout pregnancy has been reported. The neonate developed symptoms of agitation, restlessness, poor feeding, constant crying, insomnia and an enhanced startle reaction. The results of a cohort study indicate that 30% of neonates who had prolonged exposure to SSRIs in utero experience symptoms, in a dose- response manner, of a neonatal abstinence syndrome (e.g., tremor, gastrointestinal or sleep disturbances, hypertonicity, high- pitched cry) after birth. The authors suggest that infants exposed to SSRIs should be closely monitored for a minimum of 48 hours after birth. The effect of sertraline on labor and delivery in humans is unknown.

Sertraline is excreted into human milk. Adverse effects in the nursing infant are unlikely. The manufacturer recommends that caution be used when administering sertraline to nursing women.

A study of fourteen mother- infant pairs reported that while mothers receiving clinical doses of sertraline experienced substantial blockade of the platelet 5-HT transporter, platelet 5-HT uptake in nursing infants of treated mothers was unaltered. Another study of twelve breast-feeding mothers reported that both sertraline and desmethylsertraline were present in all breast milk samples. Detectable levels of sertraline were reported in three nursing infants and detectable levels of desmethylsertraline were reported in six infants. The data from one study on three breast- fed infants suggested that sertraline and/or its almost inactive metabolite norsertraline may be present at very low concentrations in the plasma of breast- fed infants. No adverse effects were noted in the infants. A case study of a mother breast-feeding while receiving sertraline therapy has also been reported. The drug was found to be present in the mother's milk. However, no sertraline was detected in the infant's serum and no abnormal occurrences were noted in the development of this infant either.

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Who should NOT use this medication?

  • Concomitant use with pimozide or an MAO inhibitor. (See Interactions.)
  • Concomitant use of sertraline oral concentrate solution (contains alcohol 12%) and disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole).
  • Known hypersensitivity to sertraline or any ingredient in the formulation.

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What does my medication look like?
Sertraline is available with a prescription under the brand name Zoloft. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you. Zoloft 25 mg-capsule-shaped, green, film-coated, scored tablets Zoloft 50 mg--capsule-shaped, light-blue, film-coated, scored tablets Zoloft 100 mg--capsule-shaped, light-yellow, film-coated, scored tablets Zoloft Oral Concentrate 20 mg/mL-clear, colorless solution with a menthol scent

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What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Symptoms of a sertraline overdose may include dizziness, drowsiness, nausea, vomiting, rapid heartbeat, agitation, tremor, confusion, seizures, and coma.

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What should I discuss with my healthcare provider before taking sertraline?
Do not use sertraline if you are using pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with sertraline. 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.

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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