Sertraline – Important Safety Information
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Sertraline and other antidepressant drugs may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Pay particular attention to such changes when sertraline is started or when the dose is changed.
Who should not take sertraline?
Do not take sertraline if:
You take a Monoamine Oxidase Inhibitor (MAOI), including linezolid or methylene blue, or if you stopped taking an MAOI in the last 2 weeks. Do not take an MAOI within 2 weeks of stopping sertraline. Ask your healthcare provider or pharmacist if you are not sure if your medicine is an MAOI. People who take sertraline close in time to an MAOI may have serious or even life threatening side effects.
Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- loss of consciousness (pass out)
Take Orap® (pimozide) because this can cause serious heart problems
Take MELLARIL® (thioridazine) because this can cause serious heart rhythm problems or sudden death.
Are allergic to sertraline or any of the ingredients in sertraline
Sertraline and other antidepressant medicines may cause serious side effects. Call a healthcare provider right away if you or a person you know who is taking sertraline has any of the following symptoms, especially if they are new, worse, or worry you:
- Attempts to commit suicide
- Acting aggressive or violent
- New or worse depression
- Feeling agitated, restless, angry, or irritable
- An increase in activity or talking more than what is normal for you
- Acting on dangerous impulses
- Thoughts about suicide or dying
- New or worse anxiety or panic attacks
- Trouble sleeping
- Other unusual changes in behavior or mood
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice new or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
What should I tell my healthcare provider before taking sertraline?
Before taking sertraline, tell your healthcare provider and pharmacist about all prescription and over-the-counter medications and supplements you take or plan to take including:
- those to treat migraines
- psychiatric disorders (including other antidepressants or amphetamines) to avoid a potentially life-threatening condition called serotonin syndrome
- other NSAID pain relievers
- other blood thinners because they may increase the risk of bleeding
- drugs used to treat irregular heartbeat
- drugs used to treat HIV infection
- drugs used to treat epilepsy
Before taking sertraline, tell your healthcare provider your complete list of medical conditions, including if you have liver problems, kidney problems, heart problems, seizures or convulsions, psychiatric disorders including bipolar disorder or mania, low sodium levels in your blood, history of a stroke, high blood pressure, bleeding problems, or glaucoma (high pressure in the eye).
Tell your healthcare provider immediately if you
- Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma, or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life-threatening condition called Serotonin Syndrome
- Have a rash, hives, swelling, or trouble breathing as these may be the symptoms of an allergic reaction
- Have seizures or convulsions
- Have any increased or unusual bruising or bleeding, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAID), or aspirin
- Have a headache; weakness or feeling unsteady; confusion, problems concentrating, thinking, or remembering, as these may be the symptoms of low salt (sodium) levels in the blood (hyponatremia). Elderly people may be at greater risk for this
Do not stop sertraline without first talking to your healthcare provider. Stopping sertraline may cause serious symptoms, including anxiety, irritability, high or low mood, feeling restless or sleepy; headache, sweating, nausea, dizziness; electric shock-like sensations, shaking, and confusion.
Some people are at risk for visual problems such as eye pain, changes in vision, or swelling or redness around the eye. You may want to undergo an eye examination to see if you are at risk and get preventative treatment if you are.
Should I avoid any activities while taking sertraline?
Sertraline can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how sertraline affects you.
Drinking alcohol while taking sertraline is not recommended.
What are the possible side effects of sertraline in adults?
The most common side effects in adults treated with sertraline include:
- Nausea, loss of appetite, diarrhea, or indigestion
- Increased sweating
- Tremor or shaking
- Change in sleep habits including increased sleepiness or insomnia
- Sexual problems including decreased libido and ejaculation failure
- Feeling tired or fatigued
- Sexual problems
- Dry mouth
- Feeling anxious or trouble sleeping
Contact your healthcare provider if you have any side effect that continues or bothers you. These are not all the possible side effects of sertraline. Contact your healthcare provider or pharmacist if you need more information.
For medical advice on side effects, contact your healthcare provider. You can also report side effects to the FDA at 1-800-FDA-1088.
Your healthcare provider or pharmacist can tell you if it is safe to take sertraline with your other medicines. Do not start or stop any medicine while taking sertraline without talking to your healthcare provider first.