"On June 28, the U.S. Food and Drug Administration approved the first generic version of Effexor XR capsules (venlafaxine hydrochloride) to treat major depressive disorder.
Venlafaxine hydrochloride extended-release capsules in 37.5 mil"...
(venlafaxine hydrochloride) Tablets
Read the Medication Guide that comes with EFFEXOR before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.
What is the most important information I should know about EFFEXOR?
EFFEXOR and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- EFFEXOR and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
- Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
- Watch for these changes and call your healthcare provider right away if you notice:
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when EFFEXOR is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:
- attempts to commit suicide
- acting on dangerous impulses
- acting aggressive or violent
- thoughts about suicide or dying
- new or worse depression
- new or worse anxiety or panic attacks
- feeling agitated, restless, angry or irritable
- trouble sleeping
- an increase in activity or talking more than what is normal for you
- other unusual changes in behavior or mood
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. EFFEXOR may be associated with these serious side effects:
2. Serotonin Syndrome
This condition can be life-threatening and may include:
- agitation, hallucinations, coma or other changes in mental status
- coordination problems or muscle twitching (overactive reflexes)
- racing heartbeat, high or low blood pressure
- sweating or fever
- nausea, vomiting, or diarrhea
- muscle rigidity
3. Changes in blood pressure. EFFEXOR may:
- increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly
4. Enlarged pupils (mydriasis).
5. Anxiety and insomnia.
6. Changes in appetite or weight.
- children and adolescents should have height and weight monitored during treatment
7. Manic/hypomanic episodes:
- greatly increased energy
- severe trouble sleeping
- racing thoughts
- reckless behavior
- unusually grand ideas
- excessive happiness or irritability
- talking more or faster than usual
8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:
- weakness or feeling unsteady
- confusion, problems concentrating or thinking or memory problems
9. Seizures or convulsions.
10. Abnormal bleeding: EFFEXOR and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.
11. Elevated cholesterol.
12. Lung disease and pneumonia: EFFEXOR may cause rare lung problems. Symptoms include:
- worsening shortness of breath
- chest discomfort
13. Severe allergic reactions:
- trouble breathing
- swelling of the face, tongue, eyes or mouth
- rash, itchy welts (hives) or blisters, alone or with fever or joint pain
Do not stop EFFEXOR without first talking to your healthcare provider. Stopping EFFEXOR too quickly or changing from another antidepressant too quickly may cause serious symptoms including:
- anxiety, irritability
- feeling tired, restless or problems sleeping
- headache, sweating, dizziness
- electric shock-like sensations, shaking, confusion, nightmares
- vomiting, nausea, diarrhea
What is EFFEXOR?
EFFEXOR is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Talk to your healthcare provider if you do not think that your condition is getting better with EFFEXOR XR treatment.
Who should not take EFFEXOR?
Do not take EFFEXOR if you:
- are allergic to EFFEXOR or any of the ingredients in EFFEXOR. See the end of this Medication Guide for a complete list of ingredients in EFFEXOR.
- have uncontrolled narrow-angle glaucoma
- take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
- Do not take an MAOI within 7 days of stopping EFFEXOR unless directed to do so by your physician.
- Do not start EFFEXOR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take EFFEXOR close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
- high fever
- uncontrolled muscle spasms
- stiff muscles
- rapid changes in heart rate or blood pressure
- loss of consciousness (pass out)
What should I tell my healthcare provider before taking EFFEXOR? Ask if you are not sure.
Before starting EFFEXOR, tell your healthcare provider if you:
- Are taking certain drugs such as:
- Medicines used to treat migraine headaches such as:
- Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
- Medicines used to treat pain such as:
- Medicines used to thin your blood such as:
- Medicines used to treat heartburn such as:
- Over-the-counter medicines or supplements such as:
- Aspirin or other NSAIDs
- St. John's Wort
- Medicines used to treat migraine headaches such as:
- have heart problems
- have diabetes
- have liver problems
- have kidney problems
- have thyroid problems
- have glaucoma
- have or had seizures or convulsions
- have bipolar disorder or mania
- have low sodium levels in your blood
- have high blood pressure
- have high cholesterol
- have or had bleeding problems
- are pregnant or plan to become pregnant. It is not known if EFFEXOR will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
- are breast-feeding or plan to breastfeed. Some EFFEXOR may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EFFEXOR.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. EFFEXOR and some medicines may interact with each other, may not work as well, or may cause serious side effects.
Your healthcare provider or pharmacist can tell you if it is safe to take EFFEXOR with your other medicines. Do not start or stop any medicine while taking EFFEXOR without talking to your healthcare provider first.
If you take EFFEXOR, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.
How should I take EFFEXOR?
- Take EFFEXOR exactly as prescribed. Your healthcare provider may need to change the dose of EFFEXOR until it is the right dose for you.
- EFFEXOR is to be taken with food.
- If you miss a dose of EFFEXOR, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of EFFEXOR at the same time.
- If you take too much EFFEXOR, call your healthcare provider or poison control center right away, or get emergency treatment.
- When switching from another antidepressant to EFFEXOR your doctor may want to lower the dose of the initial antidepressant first to avoid side effects
What should I avoid while taking EFFEXOR?
EFFEXOR can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how EFFEXOR affects you. Do not drink alcohol while using EFFEXOR.
What are the possible side effects of EFFEXOR?
EFFEXOR may cause serious side effects, including:
- See "What is the most important information I should know about EFFEXOR?"
- Increased cholesterol- have your cholesterol checked regularly
- Newborns whose mothers take EFFEXOR in the third trimester may have problems right after birth including:
- problems feeding and breathing
- shaking, jitteriness or constant crying
- Narrow-angle glaucoma/enlarged pupils. Check eye pressure regularly if you:
- have a history of increased eye pressure
- are at risk for certain types of glaucoma
Common possible side effects in people who take EFFEXOR include:
- unusual dreams
- sexual problems
- loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
- feeling tired, fatigued or overly sleepy
- change in sleep habits, problems sleeping
- tremor or shaking
- dizziness, blurred vision
- feeling anxious, nervous or jittery
- increase in heart rate
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of EFFEXOR. For more information, ask your healthcare provider or pharmacist.
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.
How should I store EFFEXOR?
- Store EFFEXOR at room temperature between 68°F and 77°F (20°C to 25°C).
- Keep EFFEXOR in a dry place.
Keep EFFEXOR and all medicines out of the reach of children.
General information about EFFEXOR
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EFFEXOR for a condition for which it was not prescribed. Do not give EFFEXOR to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about EFFEXOR. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about EFFEXOR that is written for healthcare professionals.
For more information about EFFEXOR call 1-800-934-5556.
What are the ingredients in EFFEXOR?
Active ingredient: (venlafaxine)
- Tablets: cellulose, iron oxides, lactose, magnesium stearate, and sodium starch glycolate.
This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
Last reviewed on RxList: 1/7/2013
This monograph has been modified to include the generic and brand name in many instances.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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