Important Safety Information
Sertraline Sertraline (Brand Name: Zoloft)

What are the most important things I should know about sertraline (ZOLOFT)?

Sertraline and other antidepressants can cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 in case of an emergency.

  1. Suicidal thoughts or behavior:
  • Sertraline and other antidepressants may increase suicidal thoughts or behaviors in some people age 24 and younger, especially during the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illness is the most important cause of suicidal thoughts or behavior.
  • Be aware of these changes and call your healthcare provider immediately if you notice a new or sudden change in your mood, behavior, behavior, thoughts, or feelings, especially a severe one.
    • Pay special attention to these changes when starting sertraline or changing the dose.
    • Conduct all follow-up visits with your healthcare provider and call between visits if you are concerned about developing symptoms.

Call your healthcare provider right away, or call 911 in an emergency, if you have any of the following symptoms, especially if they are new, more serious, or cause you to worry:

  • Suicide attempt
  • Aggressive or violent behavior
  • New or more severe depression
  • Feeling irritable, restless, angry, or irritable
  • Increased activity or more talking than you normally would
  • Act on dangerous impulses
  • Thoughts about suicide or death
  • New or more severe anxiety or panic attacks
  • Difficulty sleeping
  • Other abnormal changes in behavior or mood
  1. Serotonin syndrome. This condition can be life-threatening, and symptoms may include:
  • agitation, hallucinations, coma, or other changes in mental status
  • Problems with coordination or muscle twitching (overreaction)
  • Rapid heartbeat, high or low blood pressure
  • Nausea, vomiting, or diarrhea
  • Sweating or fever
  • Muscle stiffness

3. Increased chance of bleeding.

Sertraline and other antidepressants may increase the risk of bleeding or bruising, especially if you take the blood thinners warfarin (Coumadin, Jantoven®), nonsteroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen or naproxen), or aspirin®.

4. Manic episodes. Symptoms may include:

  • The energy is greatly increased
  • Racing thoughts
  • Exceptionally grandiose idea
  • Severe sleep disturbances
  • Reckless behavior
  • Excessive pleasure or irritability
  • Talking more or faster than usual
  1. Seizures or convulsions.
  2. Glaucoma (angle-closure glaucoma).

Many antidepressants, including sertraline, can cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have eye pain, vision changes, or swelling or redness in or around your eyes. Only some people are at risk of these problems. You may need an eye exam to see if you’re at risk and, if so, preventive treatment.

  1. Changes in appetite or weight. Children and adolescents should be monitored for height and weight during treatment.
  2. Low salt (sodium) levels in the blood. Older people may be at greater risk. Symptoms may include:
  • headaches
  • Weakness or feeling unstable
  • Disorganization, difficulty concentrating or thinking problems, or memory problems

Don’t stop sertraline without first talking to your healthcare provider.Discontinuing sertraline too quickly may cause serious symptoms, including:

  • Anxiety, irritability, high or low mood, restlessness, or changes in sleep habits
  • Headache, sweating, nausea, dizziness
  • Sensations like electric shocks, trembling, confusion

What is Sertraline (ZOLOFT)?

Sertraline is a prescription drug used to treat:

  • Major Depressive Disorder (MDD)
  • Panic disorder
  • Social anxiety disorder
  • Obsessive-compulsive disorder (OCD)
  • Post-Traumatic Stress Disorder (PTSD)
  • Premenstrual dysphoric disorder (PMDD)

It’s important to talk to your healthcare provider about the risks of treating depression and the risks of not treating it. You should discuss all treatment options with your healthcare provider.

Sertraline is a safe and effective treatment for children with OCD between the ages of 6 and 17.

It is unclear whether sertraline is safe and effective for children under 6 years of age with obsessive-compulsive disorder or children with other behavioral health problems.

If you don’t think your condition is getting better after sertraline treatment, talk to your healthcare provider.

Who should not take Sertraline (ZOLOFT)?

Don’t take sertraline if you have:

  • Taking monoamine oxidase inhibitors (MAOIs). If you are unsure whether to take an MAOI, including the antibiotic linezolid, talk to your healthcare provider or pharmacist.
  • Have taken an MAOI within 2 weeks of discontinuation of sertraline, unless instructed to do so by your healthcare provider.
  • Stop taking MAOIs within the past 2 weeks, unless instructed to do so by your healthcare provider.
  • Taking any other medication that contains sertraline (such as sertraline hydrochloride or sertraline hydrochloride).
  • Take the antipsychotic pimozide ( Orap® ) as this can cause serious heart problems.
  • Hypersensitivity to sertraline or any of the components in sertraline. For a complete list of sertraline ingredients, see the end of this medication guide.
  • Take Antabuse® (disulfiram) because of the alcohol content if you take sertraline in liquid form.

People who take sertraline for a period close to an MAOI may experience serious and even life-threatening side effects. Seek medical help right away if you have any of the following symptoms:

  • hyperpyrexia
  • Rapid changes in heart rate or blood pressure
  • Uncontrolled muscle spasms
  • confused
  • Stiff muscles
  • Loss of consciousness (fainting)

What should I tell my healthcare provider before taking sertraline (ZOLOFT)?

Before you start sertraline, tell your healthcare provider if you:

  • Liver problems
  • Heart problems
  • Bipolar disorder or mania
  • Kidney problems
  • Or have seizures or convulsions
  • Low levels of sodium in the blood
  • History of stroke
  • hypertension
  • Or have bleeding problems

Pregnant or planning to become pregnant. Your baby may experience withdrawal symptoms after birth, or may be at increased risk of serious lung disease at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline during pregnancy.

Breastfeeding or planning to breastfeed. A small amount of sertraline may enter your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline.

Tell your healthcare provider about all medications you take, including prescription and over-the-counter medications, vitamins and herbal supplements. Sertraline and certain medications may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it’s safe to take sertraline with other medications. While taking sertraline, do not start or stop any medication without first talking to your healthcare provider.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment can result in harm, including death in some cases.

How do I take sertraline (ZOLOFT)?

  • Sertraline is taken exactly as prescribed. Your healthcare provider may need to change the dose of sertraline until it is the right dose for you.
  • Sertraline tablets can be taken with or without food.
  • Sertraline oral solution may look cloudy or cloudy after mixing, which is normal.
  • Sertraline oral solution must be diluted before use
    • Do not mix sertraline until you are ready to take it.
    • When diluting sertraline oral solution, only water, ginger soda, lemon/lime soda, lemonade, or orange juice should be used.
    • Oral droppers contain latex. If you have a sensitivity or allergy to latex, talk to your healthcare provider or pharmacist about the best way to measure your medications.
  • If you miss a dose of sertraline, take the missed dose as soon as you remember. If it’s almost time for the next dose, skip the missed dose and take the next dose at the normal time. Do not take two doses of sertraline at the same time

If you take too much sertraline, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.

What should I avoid while taking sertraline (ZOLOFT)?

Sertraline can cause drowsiness or affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or engage in other hazardous activities until you understand the effects of sertraline on you. Do not drink alcohol while taking sertraline.

What are the possible side effects of sertraline (ZOLOFT)?

Sertraline can cause serious side effects, including:

  • See also (“What is the most important information I should know about sertraline?”)[https://www .getroman.com/drugs/sertraline/#ISI]

The most common side effects in adults taking sertraline include:

  • Nausea, loss of appetite,
  • Diarrhea or indigestion
  • Increased sweating
  • Tremors or shaking
  • stir
  • Changes in sleep habits, including increased sleepiness or insomnia
  • Sexual problems, including decreased libido and failed ejaculation
  • Feeling tired or fatigued
  • anxiety

The most common side effects in children and adolescents taking sertraline include an abnormal increase in muscle movement or agitation, nosebleeds, urinary incontinence, aggressive reactions, possible slowing of growth, and weight changes. Your child’s height and weight should be monitored during sertraline treatment.

Tell your healthcare provider if you have any side effects that bother you or won’t go away.

These are not all possible side effects of sertraline. Talk to your healthcare provider or pharmacist for more information.

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

How should I store sertraline?

  • Store sertraline at room temperature 68°F to 77°F (20°C to 25°C).
  • Cap the sertraline bottle tightly.

Keep sertraline and all medicines out of the reach of children.

General information about the safe and effective use of sertraline:

Medications are sometimes prescribed for purposes not listed in the drug guidelines. Do not use sertraline in situations not prescribed. Do not give sertraline to other people, even if they have the same condition. This can hurt them.

This medication guide summarizes the most important information about sertraline. If you want more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist about sertraline written for healthcare professionals.

For more information, call 1-800-438-1985 or visit www.pfizer.com

What are the ingredients of sertraline?

Active ingredient: Sertraline hydrochloride

Inactive Ingredients: Tablets: Dicalcium Phosphate Dihydrate, D&C Yellow #10 Aluminum Lake (25 mg Tablet), FD&C Blue #1 Aluminum Lake (25 mg Tablet), FD&C Red #40 Aluminum Lake (25 mg Tablet), FD&C Blue #2 Aluminum Lake (50 mg Tablet), Hydroxypropyl Cellulose, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Sodium starch glycolate, synthetic yellow iron oxide (100 mg tablet) and titanium dioxide.

Oral liquid: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT)

Scroll to Top