What is the most important information I should know about EFFEXOR XR?
EFFEXOR XR may cause serious side effects, including:

Increased risk of suicidal thoughts and actions: EFFEXOR XR 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. EFFEXOR XR is not for use in children.

• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, 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
• thoughts about suicide or dying
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• new or worse depression
• new or worse anxiety
• panic attacks
• feeling very agitated or restless
• new or worse irritability
• trouble sleeping
• an extreme increase in activity or talking (mania)
• other unusual changes in behavior or mood

Do not take EFFEXOR XR if you:

• are allergic to venlafaxine hydrochloride, desvenlafaxine succinate, or any of the ingredients in EFFEXOR XR. See the end of this Medication Guide for a complete list of ingredients in EFFEXOR XR.
• 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 EFFEXOR XR.

Before taking EFFEXOR XR tell your healthcare provider about all your medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. EFFEXOR XR and other medicines may affect each other causing possible serious side effects. EFFEXOR XR may affect the way other medicines work and other medicines may affect the way EFFEXOR XR works.

Do not start or stop any other medicines during treatment with EFFEXOR XR without first talking to your healthcare provider.

EFFEXOR XR may harm your unborn baby. Tell your healthcare provider if you are pregnant, plan to become pregnant, or think you are pregnant during treatment with EFFEXOR XR.

EFFEXOR XR may cause serious side effects, including:

• See, “What is the most important information I should know about EFFEXOR XR?”
• Serotonin syndrome. Taking EFFEXOR XR can cause a potentially life-threatening problem called serotonin syndrome. The risk of developing serotonin syndrome is increased when EFFEXOR XR is taken with certain other medicines. Stop taking EFFEXOR XR 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
• seeing or hearing things that are not real (hallucinations)
• confusion
• coma
• fast heartbeat
• changes in blood pressure
• dizziness
• sweating
• flushing
• high body temperature (hyperthermia)
• tremors, stiff muscles, or muscle twitching
• loss of coordination
• seizures
• nausea, vomiting, diarrhea
• Increases in blood pressure. Your healthcare provider should check your blood pressure before starting treatment and regularly during treatment with EFFEXOR XR. If you have high blood pressure, it should be controlled before you start treatment with EFFEXOR XR.
• Increased risk of bleeding. Taking EFFEXOR XR 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). EFFEXOR XR may cause a certain type of eye problem called angle-closure glaucoma. 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 EFFEXOR XR. Symptoms may include:
• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual
• Discontinuation syndrome. Suddenly stopping EFFEXOR XR may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:
• Seizures (convulsions).
• Low sodium levels in your blood (hyponatremia). Low sodium levels can happen during treatment with EFFEXOR XR. Low sodium levels in your blood may be serious and may cause death. Elderly people may be at greater risk for this.
• Lung problems. Some people who have taken the medicine venlafaxine which is the same kind of medicine as the medicine in EFFEXOR XR 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 EFFEXOR XR, may cause sexual problems.

Do not drive, or operate heavy machinery, or do other dangerous activities until you know how EFFEXOR XR affects you. EFFEXOR XR can make you drowsy.

You should not drink alcohol during treatment with EFFEXOR XR.

The most common side effects of EFFEXOR XR include:

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

These are not all the possible side effects of EFFEXOR XR. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATIONS

EFFEXOR XR (venlafaxine extended-release) capsules are a prescription medicine used to treat adults with a certain type of depression called Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), or Panic Disorder (PD).
It is not known if EFFEXOR XR is safe and effective for use in children.

Please see Full Prescribing Information, including BOXED WARNING and Medication Guide.