What is the most important information I should know about Venlafaxine Extended-Release Tablets?

Venlafaxine Extended-Release Tablets may cause serious side effects, including:

• Increased risk of suicidal thoughts and actions. Venlafaxine Extended-Release Tablets and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. Venlafaxine Extended-Release Tablets is not for use in children.
  • Depression or other serious 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 in myself or a family member?

  • Pay close attention to any changes, especially sudden changes, in mood, behavior, actions, thoughts, or feelings. 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.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting aggressive, being angry, or violent
• new or worse depression
• panic attacks
• new or worse irritability
• an extreme increase in activity or talking (mania)
• thoughts about suicide or dying
• acting on dangerous impulses
• new or worse anxiety
• feeling very agitated or restless
• trouble sleeping
• other unusual changes in behavior or mood

What is Venlafaxine Extended-Release Tablets?

Venlafaxine Extended-Release Tablets is a prescription medicine used to treat adults with:

• a certain type of depression called Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)

It is not known if Venlafaxine Extended-Release Tablets is safe and effective for use in children.

Do not take Venlafaxine Extended-Release Tablets if you:

• are allergic to venlafaxine besylate, venlafaxine hydrochloride, desvenlafaxine succinate, or any of the ingredients in Venlafaxine Extended-Release Tablets. See the end of this Medication Guide for a complete list of ingredients in Venlafaxine Extended-Release Tablets.
• take a Monoamine Oxidase Inhibitor (MAOI)
• have stopped taking an MAOI in the last 14 days
• are being treated with the antibiotic linezolid or intravenous methylene blue

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including MAOIs such as linezolid or intravenous methylene blue.

Do not start taking an MAOI for at least 7 days after you stop treatment with Venlafaxine Extended-Release Tablets.

Before taking Venlafaxine Extended-Release Tablets tell your healthcare provider about all your medical conditions, including if you:

• have, or have a family history of suicide, bipolar disorder, depression, mania or hypomania
• have high blood pressure
• have heart problems
• have cerebrovascular problems or had a stroke
• have or have had bleeding problems
• have high pressure in the eye (glaucoma)
•  have high cholesterol or high triglycerides
• have kidney or liver problems
• have or have had seizures or convulsions
• have low sodium levels in your blood
• have lung problems
• drink alcohol
• are pregnant or plan to become pregnant. Venlafaxine Extended-Release Tablets may harm your unborn baby. Talk to your healthcare provider about the risk to you and your unborn baby if you take Venlafaxine Extended-Release Tablets during pregnancy.
  • Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Venlafaxine Extended-Release Tablets.
  • Pregnancy Exposure Registry. There is a pregnancy registry for women who are exposed to Venlafaxine Extended-Release Tablets during pregnancy. The purpose of the registry is to collect information about the health of you and your baby. If you become pregnant during treatment with Venlafaxine Extended-Release Tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-844-405-6185 or by visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants.
• are breastfeeding or plan to breastfeed. Venlafaxine passes into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with Venlafaxine Extended-Release Tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Venlafaxine Extended-Release Tablets and other medicines may affect each other causing possible serious side effects. Venlafaxine Extended-Release Tablets may affect the way other medicines work and other medicines may affect the way Venlafaxine Extended-Release Tablets works.

Especially tell your healthcare provider if you take:

• medicines to treat migraine headaches known as triptans
• tricyclic antidepressants
• lithium
• tramadol, fentanyl, meperidine, methadone, or other opioids
• tryptophan
• buspirone
• amphetamines
• St. John’s Wort
• other medicines containing desvenlafaxine or venlafaxine
• phentermine
• medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take Venlafaxine Extended-Release Tablets with your other medicines.

Do not start or stop any other medicines during treatment with Venlafaxine Extended-Release Tablets without first talking to your healthcare provider. Stopping Venlafaxine Extended-Release Tablets suddenly may cause you to have serious side effects. See, “What are the possible side effects of Venlafaxine Extended-Release Tablets?”

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take Venlafaxine Extended-Release Tablets?

• Take Venlafaxine Extended-Release Tablets exactly as your healthcare provider tells you to. Do not change your dose or stop taking Venlafaxine Extended-Release Tablets without first talking to your healthcare provider.
• Your healthcare provider may need to change the dose of Venlafaxine Extended-Release Tablets until it is the right dose for you.  
• Take Venlafaxine Extended-Release Tablets 1 time each day with food.
• Venlafaxine Extended-Release Tablets may be taken either in the morning or in the evening, but you should take it the same way each time.
• Swallow Venlafaxine Extended-Release Tablets whole. Do not divide, crush, chew, or dissolve Venlafaxine Extended-Release Tablets.
• If you take too much Venlafaxine Extended-Release Tablets, call your healthcare provider or poison control center at 1-800-222-1222 or go the nearest hospital emergency room right away.

What should I avoid while taking Venlafaxine Extended-Release Tablets?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Venlafaxine Extended-Release Tablets affects you. Venlafaxine Extended-Release Tablets can make you drowsy.
• You should not drink alcohol during treatment with Venlafaxine Extended-Release Tablets. Drinking alcohol during treatment with Venlafaxine Extended-Release Tablets can increase your risk of having serious side effects. 

What are the possible side effects of Venlafaxine Extended-Release Tablets?

Venlafaxine Extended-Release Tablets may cause serious side effects, including:

• See “What is the most important information I should know about Venlafaxine Extended-Release Tablets?”
• Serotonin Syndrome. Taking Venlafaxine Extended-Release Tablets can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when Venlafaxine Extended-Release Tablets is taken with certain other medicines. See, “Do not take Venlafaxine Extended-Release Tablets if you:” Stop taking Venlafaxine Extended-Release Tablets and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
  • agitation
  • confusion
  • fast heartbeat
  • dizziness
  • flushing
  • tremors, stiff muscles, or muscle twitching
  • seizures
  • seeing or hearing things that are not real (hallucinations)
  • coma
  • changes in blood pressure
  • sweating
  • high body temperature (hyperthermia)
  • loss of coordination
  • nausea, vomiting, diarrhea
• Increases in blood pressure. Your healthcare provider should check your blood pressure before starting treatment and regularly during treatment with Venlafaxine Extended-Release Tablets. If you have high blood pressure, it should be controlled before you start treatment with Venlafaxine Extended-Release Tablets.
• Increased risk of bleeding. Taking Venlafaxine Extended-Release Tablets with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
• Eye problems (angle-closure glaucoma). Venlafaxine Extended-Release Tablets may cause a certain type of eye problem called angle-closure glaucoma in people with certain other eye conditions. You 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 have eye pain, changes in your vision, or swelling or redness in or around the eye.
• Manic episodes. Manic episodes may happen in people with bipolar disorder who take Venlafaxine Extended-Release Tablets. Symptoms may include:
  • greatly increased energy
  • racing thoughts
  • unusually grand ideas
  • talking more or faster than usual
  • severe trouble sleeping
  • reckless behavior
  • excessive happiness or irritability
• Discontinuation syndrome. Suddenly stopping Venlafaxine Extended-Release Tablets may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
  • dizziness
  • irritability and agitation
  • anxiety
  • sweating
  • seizures
  • ringing in your ears (tinnitus)
  • nausea
  • problems sleeping
  • tiredness
  • confusion
  • electric shock sensation (paresthesia)
  • headache
  • diarrhea
  • abnormal dreams
  • changes in your mood
  • hypomania
• Seizures (convulsions).
• Low sodium levels in your blood (hyponatremia). Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this. Signs and Symptoms of low sodium levels in your blood may include:
  • headache
  • difficulty concentrating
  • memory changes
  • confusion
  • weakness and unsteadiness on your feet which can lead to falls
  In severe or more sudden cases, signs and symptoms include:
  • hallucinations (seeing or hearing things that are not real)
  • fainting
  • seizures
  • coma
  • respiratory arrest
• Lung problems. Some people who have taken the medicine venlafaxine which is the same kind of medicine as the medicine in Venlafaxine Extended-Release Tablets have had lung problems. Symptoms of lung problems include difficulty breathing, cough, or chest discomfort. Tell your healthcare provider right away if you have any of these symptoms.
• Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SNRIs), including Venlafaxine Extended-Release Tablets, may cause sexual problems.
  Symptoms in males may include:
  • delayed ejaculation or inability to have an ejaculation
  • decreased sex drive
  • problems getting or keeping an erection
  Symptoms in females may include:
  • decreased sex drive
  • 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 Venlafaxine Extended-Release Tablets. There may be treatments your healthcare provider can suggest.

Your healthcare provider may tell you to stop taking Venlafaxine Extended-Release Tablets if you develop serious side effects during treatment with Venlafaxine Extended-Release Tablets.

The most common side effects of Venlafaxine Extended-Release Tablets include:

• nausea
• dry mouth
• male and female sexual problems
• loss of appetite (anorexia)
• sleepiness
• sweating
• constipation

These are not all the possible side effects of Venlafaxine Extended-Release Tablets.

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 Venlafaxine Extended-Release Tablets?

• Store Venlafaxine Extended-Release Tablets at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Venlafaxine Extended-Release Tablets in a dry place.

Keep Venlafaxine Extended-Release Tablets and all medicines out of the reach of children.

General information about the safe and effective use of Venlafaxine Extended-Release Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Venlafaxine Extended-Release Tablets for a condition for which it was not prescribed. Do not give Venlafaxine Extended-Release Tablets to other people, even if they have the same symptoms that you have. It may harm them. You may ask your healthcare provider or pharmacist for information about Venlafaxine Extended-Release Tablets that is written for healthcare professionals.