Class Name(s):

• 28:40 Fibromyalgia Agents

Pronunciation:

• (mil na' si pran)

Brand Name(s):

• Savella^®

IMPORTANT WARNING:

Milnacipran is not used to treat depression, but it belongs to the same class of medications as many antidepressants. Medications such as milnacipran 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 behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver 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 : http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

Talk to your doctor about the risks of taking milnacipran.

WHY is this medicine prescribed?

Milnacipran is used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Milnacipran is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amount of serotonin and norepinephrine, natural substances that change pain signals in the brain.

HOW should this medicine be used?

Milnacipran comes as a tablet to be taken by mouth. Take the first dose once on day 1 of therapy. Then take it two times a day. Take with or without food, but taking it with food will decrease stomach upset. Take milnacipran at around the same times every day.

Take milnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will start you on a low dose of milnacipran and gradually increase your dose during the first week of treatment.

Milnacipran may help control the symptoms of fibromyalgia, but will not cure it. Do not stop taking milnacipran without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking milnacipran, you may experience withdrawal symptoms such as mood changes, irritability, agitation, dizziness, numbness or tingling in the hands or feet, anxiety, confusion, headache, tiredness, difficulty falling asleep or staying asleep, ringing in the ears, abnormal excitement, or seizures. Tell your doctor if you experience any of these symptoms when your dose of milnacipran is decreased.

Are there OTHER USES for this medication?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking milnacipran,

• 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: monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine. If you stop taking milnacipran, your doctor may tell you that you should wait at least 5 days before you start to take an MAO inhibitor.
• some medications should not be taken with milnacipran. Other medications may cause dosing changes or extra monitoring when taken with milnacipran. Make sure you have discussed any medications you are currently taking or plan to take before starting milnacipran with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking milnacipran, please get the advice of your doctor or pharmacist.
• the following nonprescription or herbal products may interact with milnacipran: aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil^®, Motrin^®) and naproxen (Aleve^®, Naprosyn^®); St. John's wort; tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking milnacipran. Do not start any of these medications while taking milnacipran without discussing with your healthcare provider.
• tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or have ever overused prescription medications Also tell your doctor if you have or have ever had high blood pressure; seizures; an irregular heartbeat; an enlarged or inflamed prostate (a male reproductive gland); difficulty urinating; bleeding problems; or heart, kidney, or liver 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 milnacipran, call your doctor.
• you should know that milnacipran may make you drowsy and may affect your judgment, thinking, and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcoholic beverages while you are taking milnacipran.
• you should know that milnacipran may cause 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?

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

• nausea, stomach pain, vomiting
• constipation
• weight loss
• dry mouth
• feeling of extreme facial warmth and/or redness
• headache
• 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 these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• fever, sweating, confusion, fast or irregular heartbeat, severe muscle stiffness or twitching, agitation, hallucinations, loss of coordination, nausea, vomiting, or diarrhea
• headache; unsteadiness; problems with thinking, concentration, or memory problems
• seizures
• coma (loss of consciousness for a period of time)
• fast or irregular heartbeat
• greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, talking more or faster than usual
• pain in the upper right part of the stomach, yellowing of the skin or eyes, dark colored urine
• unusual bleeding or bruising
• decreased urination, unable to pass urine

Milnacipran may cause other side effects. Call your doctor if you have any unusual problems while you are 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:

• confusion
• dizziness
• extreme sleepiness, coma (loss of consciousness for a period of time)
• slowed or stopped heartbeat and breathing

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.