MEDICATION GUIDE
Lexapro® (leks-a-pro)
(escitalopram)
tablets
oral solution |
What is the most important information I should know about Lexapro?
Lexapro may cause serious side effects, including:
-
Increased risk of suicidal thoughts or actions. Lexapro and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.
○ Depression or other mental illnesses are the most important causes of suicidal thoughts or actions.
How can I watch for and try to prevent suicidal thoughts and actions?
○ Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when the dose is changed.
○ Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings or if you or your child develop suicidal thoughts or actions.
○ Keep all follow-up visits with your healthcare provider as scheduled and call your healthcare provider between visits if you are worried about symptoms.
Call your healthcare provider or get emergency medical help right away if you or your child have any of the following symptoms, especially if they are new, worse, or worry you: |
- attempts to commit suicide
|
- acting on dangerous impulses
|
- acting aggressive, being angry or violent
|
- thoughts about suicide or dying
|
|
|
|
|
|
- feeling very agitated or restless
|
- new or worse irritability
|
|
- an extreme increase in activity or talking (mania)
|
- other unusual changes in behavior or mood
|
What is Lexapro?
Lexapro is a prescription medicine used to treat:
- a certain type of depression called Major Depressive Disorder (MDD) in adults and children 12 years of age and older
- Generalized Anxiety Disorder (GAD) in adults and children 7 years of age and older
It is not known if Lexapro is safe and effective for use in children under 12 years of age with MDD or children under 7 years of age with GAD. |
Do not take Lexapro if you or your child:
- are taking, or have stopped taking within the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid or intravenous methylene blue
- are taking the antipsychotic medicine pimozide
- are allergic to escitalopram or citalopram or any of the ingredients in Lexapro. See the end of this Medication Guide for a complete list of ingredients in Lexapro.
Ask your healthcare provider or pharmacist if you are not sure if you or your child take an MAOI, including the antibiotic linezolid or intravenous methylene blue.
Do not start taking an MAOI for at least 14 days after you or your child have stopped treatment with Lexapro. |
Before taking Lexapro, tell your healthcare provider about all your medical conditions, including if you or your child:
- have or had seizures or convulsions
- have, or have a family history of bipolar disorder, mania, or hypomania
- have low blood sodium levels
- have or had bleeding problems
- have high pressure in the eye (glaucoma)
- have heart, liver, or kidney problems
- are pregnant or plan to become pregnant. Lexapro may harm the unborn baby. Taking Lexapro during the third trimester of pregnancy may cause the baby to have withdrawal symptoms, or breathing, temperature control, feeding, or other problems after birth. Talk to your healthcare provider about the risks to the baby if you or your child take Lexapro during pregnancy.
○ Tell your healthcare provider right away if you or your child become pregnant or think you may be pregnant during treatment with Lexapro.
○ There is a pregnancy registry for females who are exposed to Lexapro during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Lexapro and their baby. If you or your child become pregnant during treatment with Lexapro, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.
- are breastfeeding or plan to breastfeed. Lexapro passes into breast milk and may harm the baby. Talk to your healthcare provider about the best way to feed the baby during treatment with Lexapro.
○ If you or your child breastfeed during treatment with Lexapro, call your healthcare provider if the baby develops sleepiness or fussiness, or is not feeding or gaining weight well.
Tell your healthcare provider about all the medicines you or your child take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Lexapro and some medicines may affect each other and may cause serious side effects.
Lexapro may affect the way other medicines work and other medicines may affect the way Lexapro works.
Especially tell your healthcare provider if you take:
- medicines used to treat migraine headache known as triptans
- tricyclic antidepressants
- lithium
- tramadol, fentanyl, meperidine, methadone, or other opioids
- tryptophan
- buspirone
- amphetamines
- St. John’s Wort
- medicines used to treat mood, anxiety, psychotic or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
- diuretics
- medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) and warfarin
Ask your healthcare provider if you are not sure if you or your child are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Lexapro with your other medicines.
Do not start or stop any other medicines during treatment with Lexapro without talking to your healthcare provider first. Stopping Lexapro suddenly may cause you or your child to have serious side effects. See, “What are the possible side effects of Lexapro?”
Know the medicines you or your child take. Keep a list of them to show your healthcare provider and pharmacist when you get new medicine. |
How should I take Lexapro?
- Take Lexapro exactly as prescribed. Your healthcare provider may need to change the dose of Lexapro until it is the right dose for you or your child.
- Take Lexapro 1 time each day, in the morning or the evening.
- Take Lexapro with or without food.
- If you or your child take too much Lexapro, call your healthcare provider or Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.
|
What should I avoid while taking Lexapro?
-
Do not drive, operate heavy machinery, or do other dangerous activities until you know how Lexapro affects you. Lexapro can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.
-
Do not drink alcohol during treatment with Lexapro.
|
What are the possible side effects of Lexapro?
Lexapro may cause serious side effects, including:
- See “What is the most important information I should know about Lexapro?”
-
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when Lexapro is taken with certain other medicines. See “Do not take Lexapro if you?” Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any of the following signs and symptoms of serotonin syndrome:
|
|
|
- seeing or hearing things that are not real (hallucinations)
|
|
|
|
|
|
|
|
|
- shaking (tremors), stiff muscles, or muscle twitching
|
|
|
|
|
|
- high body temperature (hyperthermia)
|
- nausea, vomiting, diarrhea
|
|
-
Discontinuation syndrome. Suddenly stopping Lexapro may cause you or your child to have serious side effects. Your healthcare provider may want to decrease the dose slowly. Symptoms may include:
|
|
|
|
- irritability and agitation
|
|
|
|
|
- electric shock sensation (paresthesia)
|
|
|
|
- ringing in your ears (tinnitus)
|
|
|
|
|
|
-
Manic episodes. Manic episodes may happen in people with bipolar disorder who take Lexapro. Symptoms may include:
|
|
|
|
|
|
|
|
|
- excessive happiness or irritability
|
- talking more or faster than usual
| |
-
Low sodium levels in the blood (hyponatremia). Low sodium levels in the blood that may be serious and may cause death can happen during treatment with Lexapro. Elderly people and people who take certain medicines may be at greater risk for developing low sodium levels in the blood. Signs and symptoms may include:
|
|
|
- problems concentrating or thinking
|
- weakness or feeling unsteady which can lead to falls
|
|
|
| |
| In more severe or more sudden cases, signs and symptoms include: |
- seeing or hearing things that are not real (hallucinations)
|
|
|
|
|
- stopping breathing (respiratory arrest)
| |
-
Increased risk of bleeding: Taking Lexapro with aspirin, NSAIDS, warfarin, or other blood thinners may add to this risk. Tell your healthcare provider if you have any unusual bleeding or bruising.
|
-
Visual problems (angle-closure glaucoma). Lexapro may cause a type of eye problem called angle-closure glaucoma in people with certain eye problems. You or your child may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider if you or your child have:
|
|
|
|
- swelling or redness in or around the eye
|
-
Sexual problems (dysfunction). Taking Lexapro may cause sexual problems.
Symptoms in males may include:
|
- delayed ejaculation or inability to have an ejaculation
|
|
- problems getting or keeping an erection
| |
| Symptoms in females may include: |
|
|
- delayed orgasm or inability to have an orgasm
|
| Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Lexapro. There may be treatments your healthcare provider can suggest. |
| The most common side effects of Lexapro include: |
|
|
|
|
- delayed ejaculation
- nausea
|
|
- delayed orgasm or inability to have an orgasm
|
Height and weight changes in children may happen during treatment with Lexapro. Your child’s height and weight should be monitored during treatment with LEXAPRO.
These are not all the possible side effects of Lexapro.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store Lexapro?
- Store Lexapro at room temperature between 68°F to 77°F (20°C to 25°C).
-
Keep Lexapro and all medicines out of the reach of children.
|
General information about the safe and effective use of Lexapro.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lexapro for a condition for which it was not prescribed. Do not give Lexapro to other people, even if they have the same symptoms that you have. It may harm them. You may ask your pharmacist or healthcare provider for information about Lexapro that is written for health professionals. |
What are the ingredients in Lexapro?
Active ingredient: escitalopram oxalate
Inactive ingredients:
Tablets: talc, croscarmellose sodium, microcrystalline cellulose/colloidal silicon dioxide, and magnesium stearate. The film coating contains hypromellose, titanium dioxide, and polyethylene glycol
Oral solution: sorbitol, purified water, citric acid, sodium citrate, malic acid, glycerin, propylene glycol, methylparaben, propylparaben, and natural peppermint flavor
Distributed by:
AbbVie Inc.
1 N Waukegan Rd.
North Chicago, IL 60064
Licensed from H. Lundbeck A/S
©2023 AbbVie. All rights reserved.
LEXAPRO and its design are trademarks of H. Lundbeck A/S, used under license by AbbVie.
For more information about Lexapro, call 1-800-678-1605 or go to www.Lexapro.com |