EFFEXOR XR® (e-fex-or)
Read the Medication Guide that comes with EFFEXOR XR 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.
EFFEXOR XR and other antidepressant medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
- EFFEXOR XR 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 XR 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
- Visual problems
- eye pain
- changes in vision
- swelling or redness in or around the eye
Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. EFFEXOR XR 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 XR 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.
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 XR 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 XR 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.
14. Sexual Problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including EFFEXOR XR, 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 EFFEXOR XR. There may be treatments your healthcare provider can suggest.
Do not stop EFFEXOR XR without first talking to your healthcare provider. Stopping EFFEXOR XR too quickly or changing from another antidepressant too quickly may cause serious symptoms including (in some patients these symptoms can be severe and last for long time):
- anxiety, irritability, aggressiveness, violent behavior
- feeling tired, restless or problems sleeping
- headache, sweating, dizziness
- electric shock-like sensations, shaking, confusion, nightmares
- vomiting, nausea, diarrhea
- problems with eyesight such as blurred vision or trouble focusing
- increased blood pressure
EFFEXOR XR 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. EFFEXOR XR is also used to treat:
- Generalized Anxiety Disorder (GAD)
- Social Anxiety Disorder (SAD)
- Panic Disorder (PD)
Talk to your healthcare provider if you do not think that your condition is getting better with EFFEXOR XR treatment.
Do not take EFFEXOR XR if you:
- are allergic to EFFEXOR XR or any of the ingredients in EFFEXOR XR. See the end of this Medication Guide for a complete list of ingredients in EFFEXOR XR.
- have uncontrolled angle-closure 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 XR unless directed to do so by your physician.
- Do not start EFFEXOR XR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
People who take EFFEXOR XR 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)
Before starting EFFEXOR XR, 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:
- tricyclic antidepressants
- antipsychotic drugs
- 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
- have heart problems
- have diabetes
- have liver problems
- have kidney problems
- have thyroid problems
- 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 XR 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 breast-feed. Some EFFEXOR XR may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EFFEXOR XR.
Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. EFFEXOR XR 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 XR with your other medicines. Do not start or stop any medicine while taking EFFEXOR XR without talking to your healthcare provider first.
|If you take EFFEXOR XR, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.|
- Take EFFEXOR XR exactly as prescribed. Your healthcare provider may need to change the dose of EFFEXOR XR until it is the right dose for you.
- EFFEXOR XR is to be taken with food.
- If you miss a dose of EFFEXOR XR, 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 XR at the same time.
- If you take too much EFFEXOR XR, call your healthcare provider or poison control center right away, or get emergency treatment.
- When switching from another antidepressant to EFFEXOR XR your doctor may want to lower the dose of the initial antidepressant first to avoid side effects
EFFEXOR XR 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 XR affects you. Do not drink alcohol while using EFFEXOR XR.
EFFEXOR XR may cause serious side effects, including:
- See "What is the most important information I should know about EFFEXOR XR?"
- Increased cholesterol- have your cholesterol checked regularly
- Newborns whose mothers take EFFEXOR XR in the third trimester may have problems right after birth including:
- problems feeding and breathing
- shaking, jitteriness or constant crying
- Angle-closure glaucoma
Common possible side effects in people who take EFFEXOR XR 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 XR. 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.
- Store EFFEXOR XR at room temperature between 68°F and 77°F (20°C to 25°C).
- Keep EFFEXOR XR in a dry place.
Keep EFFEXOR XR 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 XR for a condition for which it was not prescribed. Do not give EFFEXOR XR to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about EFFEXOR XR. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about EFFEXOR XR that is written for healthcare professionals.
For more information about EFFEXOR XR call 1-800-438-1985 or go to www. EFFEXOR XR.com.
Active ingredient: (venlafaxine)
- Extended-Release Capsules: cellulose, ethylcellulose, gelatin, hypromellose, iron oxides, and titanium dioxide.
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
Revised: July 2021
17 PATIENT COUNSELING INFORMATION
Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Effexor XR and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Effexor XR. The prescriber or healthcare professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and should be asked to alert their prescriber if these occur while taking Effexor XR.
Suicidal Thoughts and Behaviors
Advise patients, their families and caregivers to look for the emergence of suicidality, worsening of depression, and other psychiatric symptoms (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, psychomotor restlessness, hypomania, mania, other unusual changes in behavior), especially early during treatment and when the dose is adjusted up or down. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring [see Boxed Warning and Warnings and Precautions (5.1)].
Advise patients taking Effexor XR not to use concomitantly other products containing venlafaxine or desvenlafaxine. Healthcare professionals should instruct patients not to take Effexor XR with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping Effexor XR before starting an MAOI [see Contraindications (4.2)].
Patients should be cautioned about the risk of serotonin syndrome, with the concomitant use of Effexor XR and triptans, tramadol, amphetamines, tryptophan supplements, with antipsychotics or other dopamine antagonists, or other serotonergic agents [see Warnings and Precautions (5.2) and Drug Interactions (7.3)].
Elevated Blood Pressure
Advise patients that they should have regular monitoring of blood pressure when taking Effexor XR [see Warnings and Precautions (5.3)].
Patients should be cautioned about the concomitant use of Effexor XR and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.4)].
Angle Closure Glaucoma
Patients should be advised that taking Effexor XR can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.5)].
Activation of Mania/Hypomania
Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania [see Warnings and Precautions (5.6)].
Caution is advised in administering Effexor XR to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders [see Adverse Reactions (6.1)].
Serum Cholesterol and Triglyceride Elevation
Advise patients that elevations in total cholesterol, LDL and triglycerides may occur and that measurement of serum lipids may be considered [see Warnings and Precautions (6.3)].
Advise patients not to stop taking Effexor XR without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping Effexor XR [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].
Advise patients that use of Effexor XR may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.13)].
Interference with Cognitive and Motor Performance
Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that Effexor XR therapy does not adversely affect their ability to engage in such activities.
Advise patients to avoid alcohol while taking Effexor XR [see Drug Interactions (7.6)].
Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.
Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy [see Use in Specific Populations (8.1)].
Advise patients to notify their physician if they are breast-feeding an infant [see Use in Specific Populations (8.3)].
Effexor XR contains spheroids, which release the drug slowly into the digestive tract. The insoluble portion of these spheroids is eliminated, and patients may notice spheroids passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the spheroids.