Effexor XR 37.5mg Capsules
WARNING: Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like depression, nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.This drug is not approved for use in children. Talk with the doctor. @ COMMON USES: It is used to treat depression.It is used to treat anxiety.It is used to treat panic attacks.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antidepressant
Pharmacologic Class
Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)
Pregnancy Category
Category C
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Effexor XR is an extended-release capsule that contains venlafaxine, a medicine used to treat depression, anxiety, and panic disorder. It works by helping to restore the balance of certain natural substances (serotonin and norepinephrine) in the brain, which can improve mood and reduce feelings of anxiety.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication with food to help your body absorb it properly.
Swallow the capsule whole - do not crush, chew, or dissolve it.
If you have trouble swallowing the capsule, you can sprinkle its contents onto a small amount of applesauce. However, do not chew the mixture. Swallow it immediately and follow with a glass of cool water.
It's essential to establish a routine when taking your medication. Take your dose at the same time every day, and continue taking it as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you forget to take a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take your medication with food to help your body absorb it properly.
Swallow the capsule whole - do not crush, chew, or dissolve it.
If you have trouble swallowing the capsule, you can sprinkle its contents onto a small amount of applesauce. However, do not chew the mixture. Swallow it immediately and follow with a glass of cool water.
It's essential to establish a routine when taking your medication. Take your dose at the same time every day, and continue taking it as directed by your doctor or healthcare provider, even if you start feeling better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. Check with your pharmacist for guidance on the best disposal methods, and consider participating in local drug take-back programs.
What to Do If You Miss a Dose
If you forget to take a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed, usually once daily with food, at approximately the same time each day.
- Swallow the capsule whole; do not crush, chew, or dissolve.
- Avoid alcohol, as it can increase side effects.
- Be aware that it may take several weeks to feel the full benefits of the medication.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause withdrawal symptoms.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause dizziness or drowsiness.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
37.5 mg once daily for 4-7 days, then increase to 75 mg once daily. Max 225 mg/day.
Dose Range:
37.5 - 225 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial: 37.5 mg once daily for 4-7 days, then 75 mg once daily. May increase by 75 mg/day increments at intervals of not less than 4 days, up to 225 mg/day. Some patients may benefit from doses up to 375 mg/day.
Generalized Anxiety Disorder (GAD):
Initial: 37.5 mg once daily for 4-7 days, then 75 mg once daily. May increase by 75 mg/day increments at intervals of not less than 4 days, up to 225 mg/day.
Social Anxiety Disorder (SAD):
Initial: 75 mg once daily. No evidence of additional benefit at doses greater than 75 mg/day.
Panic Disorder (PD):
Initial: 37.5 mg once daily for 7 days, then 75 mg once daily. May increase by 75 mg/day increments at intervals of not less than 7 days, up to 225 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use; safety and efficacy not established for MDD in pediatric patients. Use generally not recommended due to increased risk of suicidality.
Adolescent:
Not established for routine use; safety and efficacy not established for MDD in pediatric patients. Use generally not recommended due to increased risk of suicidality.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (CrCl 60-90 mL/min).
Moderate:
Reduce total daily dose by 25-50% (CrCl 30-59 mL/min).
Severe:
Reduce total daily dose by 50% or more (CrCl <30 mL/min).
Dialysis:
Reduce total daily dose by 50% and withhold dose until after dialysis session (hemodialysis patients).
Hepatic Impairment:
Mild:
Reduce total daily dose by 25% (Child-Pugh A).
Moderate:
Reduce total daily dose by 50% (Child-Pugh B).
Severe:
Reduce total daily dose by 50% or more (Child-Pugh C).
Pharmacology
Mechanism of Action
Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and a weak inhibitor of dopamine reuptake. This dual reuptake inhibition is thought to potentiate neurotransmitter activity in the CNS, leading to its antidepressant and anxiolytic effects. Venlafaxine and ODV have no significant affinity for muscarinic, histaminergic, or alpha-1 adrenergic receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 45% (oral)
Tmax:
Venlafaxine: 5.5 hours; ODV: 9 hours
FoodEffect:
Food does not significantly affect the absorption or extent of absorption of venlafaxine or ODV.
Distribution:
Vd:
Venlafaxine: 7.5 L/kg; ODV: 5.7 L/kg
ProteinBinding:
Venlafaxine: 27%; ODV: 30%
CnssPenetration:
Yes
Elimination:
HalfLife:
Venlafaxine: 5 Âą 2 hours; ODV: 11 Âą 2 hours
Clearance:
Venlafaxine: 1.3 Âą 0.6 L/h/kg; ODV: 0.4 Âą 0.2 L/h/kg
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Venlafaxine: 5%; ODV: 30% (of total dose)
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial antidepressant effects; full effect may take 4-6 weeks.
PeakEffect:
4-6 weeks for full therapeutic effect.
DurationOfAction:
24 hours (due to extended-release formulation and active metabolite half-life).
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond 24 years of age; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, difficulty focusing, memory problems, confusion, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation problems, or erectile dysfunction
A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek immediate medical attention if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
As with any medication, you may experience side effects. While many people do not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Difficulty sleeping
Feeling anxious, nervous, or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Vivid or unusual dreams
Yawning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of low sodium levels: headache, difficulty focusing, memory problems, confusion, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sexual problems, including decreased libido, difficulty achieving orgasm, ejaculation problems, or erectile dysfunction
A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek immediate medical attention if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache
Other Possible Side Effects
As with any medication, you may experience side effects. While many people do not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Difficulty sleeping
Feeling anxious, nervous, or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Vivid or unusual dreams
Yawning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening depression or thoughts of harming yourself
- New or worsening anxiety, panic attacks, agitation, restlessness, irritability, or other unusual changes in behavior
- Severe headache, confusion, rapid heartbeat, sweating, muscle stiffness, twitching, or fever (signs of serotonin syndrome)
- New or worsening high blood pressure
- Eye pain, changes in vision, swelling or redness in or around the eye (signs of angle-closure glaucoma)
- Unusual bleeding or bruising
- Seizures
- Symptoms of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have high blood pressure, as this condition may be affected by the medication.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are currently taking a weight loss drug, as this may interact with the medication.
If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can interact with the medication.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug can cause very high blood pressure.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Sharing this information will help your doctor determine if it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions and situations to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have high blood pressure, as this condition may be affected by the medication.
If you have narrow-angle glaucoma, a condition that affects the eyes.
If you are currently taking a weight loss drug, as this may interact with the medication.
If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these can interact with the medication.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. Taking these medications with this drug can cause very high blood pressure.
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Sharing this information will help your doctor determine if it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent potential interactions with other treatments.
Until you know how this medication affects you, avoid driving and other activities that require your full attention. This is crucial to prevent accidents and ensure your safety.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of experiencing side effects, which can be severe and long-lasting. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks. Be sure to discuss any new or worsening symptoms with your doctor.
Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.
It is recommended to avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or slow your reactions.
This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor, especially if you experience any unusual bleeding or bruising.
If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience symptoms such as increased energy, agitation, or reckless behavior.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, seek medical attention promptly.
Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, it can be fatal. Discuss this risk with your doctor and report any symptoms such as headache, confusion, or seizures.
High cholesterol has been reported in some individuals taking this medication. If you have concerns or questions, consult your doctor.
This medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test results.
You may notice remnants of the medication in your stool, but this is a normal and harmless occurrence. However, if you have any concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor this potential risk. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the benefits and risks of taking this medication. Taking this medication in mid to late pregnancy may increase the risk of health problems for both the mother (such as postpartum bleeding) and the newborn. Your doctor will help you weigh the benefits and risks and make an informed decision.
Until you know how this medication affects you, avoid driving and other activities that require your full attention. This is crucial to prevent accidents and ensure your safety.
Do not stop taking this medication abruptly without consulting your doctor, as this may increase your risk of experiencing side effects, which can be severe and long-lasting. If you need to discontinue this medication, your doctor will guide you on how to gradually stop taking it to minimize potential risks. Be sure to discuss any new or worsening symptoms with your doctor.
Regular blood pressure checks are necessary while taking this medication, as it may cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.
It is recommended to avoid consuming alcohol while taking this medication. Additionally, consult your doctor before using marijuana, cannabis, or any prescription or over-the-counter medications that may cause drowsiness or slow your reactions.
This medication may increase your risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor, especially if you experience any unusual bleeding or bruising.
If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience symptoms such as increased energy, agitation, or reckless behavior.
Some individuals may be at a higher risk of developing eye problems while taking this medication. Your doctor may recommend an eye exam to assess your risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, seek medical attention promptly.
Low blood sodium levels (hyponatremia) can occur with this medication, and in severe cases, it can be fatal. Discuss this risk with your doctor and report any symptoms such as headache, confusion, or seizures.
High cholesterol has been reported in some individuals taking this medication. If you have concerns or questions, consult your doctor.
This medication may affect the results of certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test results.
You may notice remnants of the medication in your stool, but this is a normal and harmless occurrence. However, if you have any concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
In children and adolescents, this medication may affect growth in some cases. Regular growth checks may be necessary to monitor this potential risk. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the benefits and risks of taking this medication. Taking this medication in mid to late pregnancy may increase the risk of health problems for both the mother (such as postpartum bleeding) and the newborn. Your doctor will help you weigh the benefits and risks and make an informed decision.
Overdose Information
Overdose Symptoms:
- Somnolence
- Mild tremor
- Nausea
- Vomiting
- Dizziness
- Tachycardia
- Mydriasis
- Seizures
- ECG changes (e.g., QT prolongation, bundle branch block, QRS prolongation)
- Coma
- Death
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. There is no specific antidote. Treatment is symptomatic and supportive, including maintaining an adequate airway, oxygenation, and ventilation. Activated charcoal may be considered. Gastric lavage may be indicated shortly after ingestion. Monitor cardiac rhythm and vital signs.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of stopping MAOI, or starting MAOI within 7 days of stopping venlafaxine)
Major Interactions
- Other serotonergic drugs (e.g., SSRIs, triptans, fentanyl, lithium, tramadol, St. John's Wort, tryptophan) - increased risk of serotonin syndrome
- Linezolid (MAOI activity)
- Methylene blue (MAOI activity)
- Anticoagulants (e.g., warfarin) - increased risk of bleeding
- Antiplatelet agents (e.g., aspirin, NSAIDs) - increased risk of bleeding
- Drugs that prolong QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics) - theoretical risk of QT prolongation
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels
Moderate Interactions
- Alcohol (may enhance CNS effects and impair psychomotor skills)
- Cimetidine (may inhibit first-pass metabolism of venlafaxine, increasing AUC)
- Drugs affecting blood pressure (e.g., antihypertensives) - venlafaxine can cause dose-dependent increases in blood pressure
- CNS depressants (e.g., benzodiazepines, hypnotics, sedatives) - additive CNS depression
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: Venlafaxine can cause sustained dose-related increases in blood pressure.
Timing: Prior to initiation
Heart Rate
Rationale: Can cause increases in heart rate.
Timing: Prior to initiation
Weight
Rationale: Can cause weight changes (gain or loss).
Timing: Prior to initiation
Psychiatric History (including bipolar disorder, mania/hypomania)
Rationale: Risk of activating mania/hypomania in susceptible individuals.
Timing: Prior to initiation
Glaucoma (narrow-angle)
Rationale: Risk of mydriasis and acute angle-closure glaucoma.
Timing: Prior to initiation
Sodium levels (especially in elderly or those on diuretics)
Rationale: Risk of hyponatremia/SIADH.
Timing: Prior to initiation if risk factors present
Routine Monitoring
Blood Pressure
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Within normal limits for the patient
Action Threshold: Significant or sustained elevation; consider dose reduction or alternative treatment.
Heart Rate
Frequency: Periodically
Target: Within normal limits for the patient
Action Threshold: Significant or sustained elevation.
Weight
Frequency: Periodically
Target: Stable or within healthy range
Action Threshold: Significant or undesirable weight change.
Suicidal Ideation/Behavior
Frequency: Especially during initial treatment and dose changes.
Target: Absence of ideation/behavior
Action Threshold: Emergence or worsening of suicidal thoughts/behavior; immediate clinical intervention.
Symptoms of Depression/Anxiety
Frequency: Regularly, at each visit.
Target: Improvement or remission of symptoms
Action Threshold: Lack of improvement, worsening symptoms, or emergence of new symptoms.
Serotonin Syndrome symptoms
Frequency: Monitor closely, especially when co-administered with other serotonergic drugs.
Target: Absence of symptoms
Action Threshold: Agitation, hallucinations, delirium, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea; discontinue venlafaxine and provide supportive care.
Bleeding events
Frequency: Monitor for signs of unusual bleeding, especially with concomitant use of anticoagulants/antiplatelets.
Target: Absence of unusual bleeding
Action Threshold: Unexplained bruising, petechiae, purpura, GI bleeding; investigate and manage.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior or mood (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Symptoms of withdrawal (e.g., dizziness, headache, nausea, insomnia, irritability, anxiety, paresthesia, fatigue, flu-like symptoms) upon discontinuation
- New or worsening high blood pressure
- Eye pain, changes in vision, swelling or redness in or around the eye (angle-closure glaucoma)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Exposure during late pregnancy may lead to complications in the neonate requiring prolonged hospitalization, respiratory support, and tube feeding.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major congenital malformations.
Second Trimester:
Not available
Third Trimester:
Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, feeding difficulties, irritability, tremor, hypotonia, constant crying).
Lactation
Venlafaxine and ODV are excreted into breast milk. The American Academy of Pediatrics considers venlafaxine to be a drug for which the effect on a nursing infant is unknown but may be of concern. Monitor infants for sedation, poor feeding, and poor weight gain. Use with caution.
Infant Risk:
L3 (Moderate concern)
Pediatric Use
Not approved for use in pediatric patients for MDD due to increased risk of suicidality. Safety and efficacy have not been established. Use only if potential benefits outweigh risks, and with close monitoring.
Geriatric Use
No overall differences in efficacy were observed between elderly and younger patients, but elderly patients may be more sensitive to the effects of venlafaxine, particularly hyponatremia and dose-related increases in blood pressure. Lower starting doses and slower titration may be appropriate. Monitor for falls and cognitive changes.
Clinical Information
Clinical Pearls
- Venlafaxine XR should be taken with food to minimize GI upset and ensure consistent absorption.
- Capsules should be swallowed whole; the capsule shell may be excreted in the stool, which is normal and does not mean the medication was not absorbed.
- Dose-dependent increases in blood pressure are a known side effect; monitor BP regularly, especially during dose titration.
- Discontinuation syndrome (withdrawal) is common and can be severe; taper dose gradually over several weeks to months, depending on dose and duration of therapy.
- Serotonin syndrome is a rare but serious risk, especially when co-administered with other serotonergic agents. Educate patients on symptoms.
- Patients who are poor CYP2D6 metabolizers may have higher venlafaxine levels and lower ODV levels, but dose adjustment is generally not required unless clinical response or side effects warrant it.
Alternative Therapies
- Other SNRIs (e.g., duloxetine, desvenlafaxine, levomilnacipran)
- SSRIs (e.g., fluoxetine, sertraline, escitalopram, citalopram, paroxetine)
- Atypical antidepressants (e.g., bupropion, mirtazapine)
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline)
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, selegiline)
- Psychotherapy (e.g., Cognitive Behavioral Therapy)
Cost & Coverage
Average Cost:
$10 - $50 per 30 capsules (generic 37.5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and thoroughly, and to review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is crucial to read this guide carefully and thoroughly, and to review it again whenever your prescription is refilled. If you have any questions or concerns about your medication, do not hesitate to consult with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.