Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressant.

Desvenlafaxine is used to treat major depressive disorder.

Desvenlafaxine may also be used for purposes not listed in this medication guide.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Do not stop using desvenlafaxine without first asking your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take desvenlafaxine with water at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

Your symptoms may not improve for several weeks.

Your blood pressure will need to be checked often.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using desvenlafaxine suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.

Part of a tablet shell may appear in your stool but this will not make the medicine less effective.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

50 mg orally once a day, with or without food

Comments:
-Doses of 10 to 400 mg/day were studied in clinical trials.
-There is no evidence that doses greater than 50 mg per day provide additional benefit.
-Side effects and discontinuations were more common at higher doses.
-Efficacy in patients with major depressive disorder was established in 4 short-term and 2 maintenance studies.

Use: Treatment of major depressive disorder (MDD)

You should not use desvenlafaxine if you are allergic to desvenlafaxine or venlafaxine (Effexor).

Do not use desvenlafaxine within 7 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. A dangerous drug interaction could occur.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with desvenlafaxine could cause a serious condition called serotonin syndrome.

Tell your doctor if you have ever had:

• heart disease, high blood pressure, high cholesterol, or a stroke;

• bipolar disorder (manic depression);

• depression, suicidal thoughts;

• liver or kidney disease;

• glaucoma;

• seizures or epilepsy;

• sexual problems;

• lung or breathing problems;

• a bleeding or blood clotting disorder; or

• low levels of sodium in your blood.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Taking this medicine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop desvenlafaxine without asking your doctor.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of desvenlafaxine on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

Avoid driving or hazardous activity until you know how desvenlafaxine will affect you. Your reactions could be impaired.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with desvenlafaxine may cause you to bruise or bleed easily.

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Desvenlafaxine may cause serious side effects. Call your doctor at once if you have:

• a seizure;

• easy bruising or bleeding (nosebleeds, bleeding gums), blood in your urine or stools, coughing up blood;

• blurred vision, eye pain or swelling, or seeing halos around lights;

• cough, chest discomfort, trouble breathing; or

• low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of desvenlafaxine may include:

• dizziness, drowsiness, anxiety;

• increased sweating;

• nausea, decreased appetite, constipation;

• sleep problems (insomnia); or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Using desvenlafaxine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially a blood thinner (warfarin, Coumadin, Jantoven) or other medicine used to prevents blood clots.

Other drugs may affect desvenlafaxine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory.

The extended-release tablet does not dissolve in the stomach after swallowing. It slowly releases the medicine as it passes through your digestive system. You may notice the tablet coating in the stool. This is normal and does not mean that you did not receive the complete dose of medication.

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.