Drug Details
Drug Name(s) EFFEXOR
FDA Application No. (NDA) 020151
Active Ingredient(s) VENLAFAXINE HYDROCHLORIDE
CompanyWYETH PHARMS INC
Original Approval or
Tentative Approval Date December 28, 1993
Chemical Type1 New molecular entity (NME)
Review ClassificationS Standard review drug
Drug Name(s) EFFEXOR
FDA Application No. (NDA) 020151
Active Ingredient(s) VENLAFAXINE HYDROCHLORIDE
CompanyWYETH PHARMS INC
Original Approval or
Tentative Approval Date December 28, 1993
Chemical Type1 New molecular entity (NME)
Review ClassificationS Standard review drug
Uses
Venlafaxine is used to treat depression. It may improve your mood and energy level, and may help restore your interest in daily living. Venlafaxine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat anxiety and panic attacks. It may also be used to treat hot flashes that occur with menopause.
How to use Effexor
Read the Medication Guide provided by your pharmacist before you start using venlafaxine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually 2 to 3 times daily with food.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as confusion, mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.
It may take several weeks to feel the benefit of this medication. Tell your doctor if your condition persists or worsens.
Venlafaxine is used to treat depression. It may improve your mood and energy level, and may help restore your interest in daily living. Venlafaxine is known as a serotonin-norepinephrine reuptake inhibitor (SNRI). It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat anxiety and panic attacks. It may also be used to treat hot flashes that occur with menopause.
How to use Effexor
Read the Medication Guide provided by your pharmacist before you start using venlafaxine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth as directed by your doctor, usually 2 to 3 times daily with food.
The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as confusion, mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock. Your dose may need to be gradually decreased to reduce side effects. Report any new or worsening symptoms right away.
It may take several weeks to feel the benefit of this medication. Tell your doctor if your condition persists or worsens.
Side Effects
Nausea, drowsiness, dizziness, dry mouth, constipation, loss of appetite, blurred vision, nervousness, trouble sleeping, unusual sweating, or yawning may occur. If any of these effects persist or worsen, tell your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if any of these unlikely but serious side effects occur: easy bruising/bleeding, decreased interest in sex, changes in sexual ability, muscle cramps/weakness, shaking (tremor).
Get medical help right away if any of these rare but serious side effects occur: black/bloody stools, persistent cough, seizure, severe/pounding headache, shortness of breath, vomit that looks like coffee grounds, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Nausea, drowsiness, dizziness, dry mouth, constipation, loss of appetite, blurred vision, nervousness, trouble sleeping, unusual sweating, or yawning may occur. If any of these effects persist or worsen, tell your doctor promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Tell your doctor right away if any of these unlikely but serious side effects occur: easy bruising/bleeding, decreased interest in sex, changes in sexual ability, muscle cramps/weakness, shaking (tremor).
Get medical help right away if any of these rare but serious side effects occur: black/bloody stools, persistent cough, seizure, severe/pounding headache, shortness of breath, vomit that looks like coffee grounds, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).
This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Precautions
Before taking venlafaxine, tell your doctor or pharmacist if you are allergic to it; or to desvenlafaxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, personal or family history of glaucoma (angle-closure type), high blood pressure, heart problems (such as heart failure, previous heart attack), high cholesterol, kidney disease, liver disease, seizure disorder, thyroid disease.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially dizziness when standing and bleeding. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are taking "water pills" (diuretics). Dizziness and salt imbalance can increase the risk of falling.
Children may be more sensitive to the side effects of the drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.
Since untreated mental/mood problems (such as depression, anxiety, panic attacks) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Before taking venlafaxine, tell your doctor or pharmacist if you are allergic to it; or to desvenlafaxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, personal or family history of glaucoma (angle-closure type), high blood pressure, heart problems (such as heart failure, previous heart attack), high cholesterol, kidney disease, liver disease, seizure disorder, thyroid disease.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially dizziness when standing and bleeding. Older adults may also be more likely to develop a type of salt imbalance (hyponatremia), especially if they are taking "water pills" (diuretics). Dizziness and salt imbalance can increase the risk of falling.
Children may be more sensitive to the side effects of the drug, especially loss of appetite and weight loss. Monitor weight and height in children who are taking this drug.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.
Since untreated mental/mood problems (such as depression, anxiety, panic attacks) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.
This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.