Class Name(s):

• 28:16.04.16 Selective Serotonin- and Norepinephrine-reuptake Inhibitors

Pronunciation:

• (doo lox' e teen)

Brand Name(s):

• Cymbalta^®
• Drizalma Sprinkle^®; also available generically

IMPORTANT WARNING:

Medications such as duloxetine may increase the risk of suicidal thoughts and actions. This increase was found in children, teenagers, and young adults (less than 24 years of age). The risk may be more likely with the first few months of treatment and when the dose is increased.

Call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive or hostile behavior; irritability; acting without thinking; severe restlessness; frenzied abnormal excitement; or any other unusual changes in behavior. Be sure that your family or caregiver checks on you daily and knows which symptoms may be serious so they can call the doctor if you are unable to do so

The doctor or pharmacist will give you the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking duloxetine.

WHY is this medicine prescribed?

Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life). Duloxetine is also used to pain associated with diabetic neuropathy (damage to nerves that can develop in people who have diabetes) and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). It is also used to treat ongoing bone or muscle pain. Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of certain natural substances in the brain.

HOW should this medicine be used?

Duloxetine comes as a delayed-release (releases the medication in the intestine to prevent break-down of the medication by stomach acids) capsule to take by mouth. It is taken 1 to 2 times daily with or without food depending on the reason it is being used. Take duloxetine at around the same time(s) every day.

Take duloxetine exactly as directed. Do not take more or less of it, take it more often, or take it for a longer time than prescribed by your doctor.

Swallow the delayed-release capsules whole; do not split, chew, or crush them.

If you are unable to swallow the capsules, duloxetine (Drizalma Sprinkle^®) delayed-release capsules may be opened and the contents sprinkled over applesauce.

Duloxetine (Drizalma Sprinkle^®) delayed-release capsules may be given through a nasogastric tube. Ask your doctor or pharmacist for instructions.

Your doctor may start you on a low dose of medication and increase your dose after one week.

Duloxetine may help control your symptoms but will not cure your condition. It may take 1 to 4 weeks or longer before you feel the full benefit of duloxetine. Continue to take duloxetine even if you feel well.

Do not stop taking duloxetine without talking to your doctor. If you suddenly stop taking duloxetine, you may experience withdrawal symptoms such as nausea; vomiting; diarrhea; anxiety; dizziness; tiredness; headache; pain, burning, numbness, or tingling in the hands or feet; irritability; difficulty falling asleep or staying asleep; sweating; and nightmares.

Are there OTHER USES for this medication?

Duloxetine is also sometimes used to treat stress urinary incontinence (leakage of urine during physical activity such as coughing, sneezing, laughing, and exercise) in women. Talk to your doctor about using this medication to treat your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking duloxetine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: thioridazine or a monoamine oxidase (MAO) inhibitor, such as isocarboxazid, linezolid; methylene blue; phenelzine, selegiline and tranylcypromine. Your doctor will probably tell you not to take duloxetine. If you stop taking duloxetine, you should wait at least 5 days before you start to take an MAO inhibitor.
• some medications should not be taken with duloxetine. Other medications may cause dosing changes or extra monitoring when taken with duloxetine. Make sure you have discussed any medications you are currently taking or plan to take before starting duloxetine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking duloxetine, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with duloxetine: St. John's wort; tryptophan; proton pump inhibitors such as lansoprazole, omeprazole, pantoprazole, and rabeprazole; cimetidine; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking duloxetine. Do not start any of these medications while taking duloxetine without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or if you use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have a low level of sodium in your blood; glaucoma (increased pressure in the eye that may cause loss of sight); if you have recently had a heart attack; or if you have or have ever had high blood pressure; diabetes; seizures; coronary artery disease (blockage or narrowing of the blood vessels that lead to the heart); bleeding problems; any type of stomach problem such as slow stomach emptying; or heart, liver, or kidney disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking duloxetine, call your doctor.
• you should know that duloxetine may make you drowsy, dizzy, or may affect your judgment, thinking or coordination. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking duloxetine. Alcohol can increase the risk of serious side effects from duloxetine.
• you should know that duloxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking duloxetine or with an increase in dose. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that duloxetine may cause high blood pressure. You should have your blood pressure checked before starting treatment and regularly while you are taking this medication.
• you should know that duloxetine may cause or worsen angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Duloxetine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea, vomiting, diarrhea, constipation
• decreased appetite, weight changes
• dry mouth
• sweating or night sweats
• tiredness
• sexual problems in males; decreased sex drive, inability to get or keep an erection, or delayed or absent ejaculation
• sexual problems in females; decreased sex drive, or delayed orgasm or unable to have an orgasm

Some side effects can be serious. If you experience any of the following side effects, or those mentioned in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• loss of appetite, unusual bruising or bleeding, itching, pain in the upper right part of the stomach, yellowing of the skin or eyes, dark colored urine
• extreme tiredness or weakness, confusion, unsteady walking that may cause falling
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• seizures
• fever; rash; hives; blisters or peeling skin; difficulty breathing or swallowing; hoarseness; swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• difficulty urinating

Duloxetine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• increased or decreased blood pressure
• seizures
• dizziness, lightheadedness, fainting
• drowsiness, unresponsiveness

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2025.