Effexor XR 150mg 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 antidepressant medication that works by affecting certain natural chemicals in the brain (serotonin and norepinephrine) that help regulate mood. It is used to treat depression, anxiety, and panic disorder. The 'XR' means extended-release, so it releases the medicine slowly over time, allowing you to take it once a day.
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 or its contents.
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 it at the same time every day, as directed by your doctor or healthcare provider. Continue taking your medication even if you start feeling well, unless your doctor instructs you to stop.
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 of your medication:
Take the missed dose as soon as you remember.
However, if it's almost 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 a missed dose.
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 or its contents.
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 it at the same time every day, as directed by your doctor or healthcare provider. Continue taking your medication even if you start feeling well, unless your doctor instructs you to stop.
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 of your medication:
Take the missed dose as soon as you remember.
However, if it's almost 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 a missed dose.
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 it. If you cannot swallow the capsule, you may open it and sprinkle the contents on a spoonful of applesauce and swallow immediately without chewing.
- Do not stop taking this medication suddenly without talking to your doctor, as this can cause unpleasant withdrawal symptoms.
- Avoid alcohol while taking this medication, as it can increase side effects.
- Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause dizziness or drowsiness.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort or other antidepressants.
- Monitor your blood pressure regularly as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
75 mg once daily
Dose Range:
37.5 - 225 mg
Condition-Specific Dosing:
Major Depressive Disorder (MDD):
Initial 75 mg once daily; may increase by 75 mg/day increments at intervals of 4 days or more, up to 225 mg/day. For some hospitalized patients with severe depression, doses up to 375 mg/day may be used.
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 4 days or more, up to 225 mg/day.
Social Anxiety Disorder (SAD):
Initial 75 mg once daily.
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 7 days or more, up to 225 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for MDD; safety and efficacy not established for other indications. Use generally not recommended due to Black Box Warning.
Adolescent:
Not established for MDD; safety and efficacy not established for other indications. Use generally not recommended due to Black Box Warning.
Dose Adjustments
Renal Impairment:
Mild:
No 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% or more; administer after dialysis session.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Reduce total daily dose by 50%
Severe:
Reduce total daily dose by 50% or more
Pharmacology
Mechanism of Action
Venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. The antidepressant and anxiolytic effects are believed to be related to the potentiation of neurotransmitter activity in the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 92% (oral)
Tmax:
Venlafaxine: 5.5 hours (XR); ODV: 9 hours (XR)
FoodEffect:
Food delays Tmax by 2-3 hours but does not significantly affect AUC or Cmax of venlafaxine or ODV.
Distribution:
Vd:
Approximately 5.7 L/kg
ProteinBinding:
Venlafaxine: Approximately 27%; ODV: Approximately 30%
CnssPenetration:
Yes
Elimination:
HalfLife:
Venlafaxine: Approximately 5 hours; ODV: Approximately 11 hours
Clearance:
Venlafaxine: 1.3 ± 0.6 L/h/kg; ODV: 0.4 ± 0.2 L/h/kg
ExcretionRoute:
Primarily renal (approximately 87% within 48 hours, mostly as metabolites)
Unchanged:
Approximately 5% (venlafaxine); Approximately 29% (ODV)
Pharmacodynamics
OnsetOfAction:
Initial effects may be seen within 1-2 weeks; full therapeutic effects may take 4-6 weeks.
PeakEffect:
Typically 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. Effexor XR is not approved for use in pediatric patients.
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 or seek medical attention immediately:
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, trouble focusing, memory problems, feeling confused, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that looks like coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrolled bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex problems, including decreased interest in sex, trouble having an orgasm, ejaculation problems, or difficulty getting or maintaining an erection
A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Trouble sleeping
Feeling nervous, anxious, or excitable
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite
Gas
Dry mouth
Strange or unusual dreams
* Yawning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 or seek medical attention immediately:
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, trouble focusing, memory problems, feeling confused, weakness, seizures, or changes in balance
Signs of bleeding: vomiting or coughing up blood, vomit that looks like coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that get bigger, or uncontrolled bleeding
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in eyesight
Seizures
Chest pain or pressure
Shortness of breath
Cough
Bone pain
Sex problems, including decreased interest in sex, trouble having an orgasm, ejaculation problems, or difficulty getting or maintaining an erection
A rare but potentially life-threatening condition called serotonin syndrome may occur, especially if you are taking certain other medications. Seek medical help immediately if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Trouble sleeping
Feeling nervous, anxious, or excitable
Weight loss
Dizziness, drowsiness, tiredness, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach upset, vomiting, or decreased appetite
Gas
Dry mouth
Strange or unusual dreams
* Yawning
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 anxiety
- New or increased thoughts of self-harm or suicide
- Unusual changes in behavior (e.g., agitation, restlessness, panic attacks, insomnia, irritability, aggression, impulsivity, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., confusion, hallucinations, rapid heart rate, sweating, muscle stiffness, tremors, fever, severe nausea/vomiting/diarrhea)
- Severe headache, blurred vision, eye pain, or seeing halos around lights (signs of acute narrow-angle glaucoma)
- Unexplained bruising or bleeding
- Seizures
- Symptoms of hyponatremia (e.g., headache, confusion, weakness, unsteadiness, memory problems)
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 medications 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 medication may affect your condition.
If you have narrow-angle glaucoma, a condition that affects the pressure in your eyes.
If you are 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 cause serious interactions.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. This is crucial because combining these medications can lead to very high blood pressure.
This list is not exhaustive, and it is vital to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. 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 medications 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 medication may affect your condition.
If you have narrow-angle glaucoma, a condition that affects the pressure in your eyes.
If you are 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 cause serious interactions.
+ Certain drugs for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, within the last 14 days. This is crucial because combining these medications can lead to very high blood pressure.
This list is not exhaustive, and it is vital to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Your doctor and pharmacist need this information to assess potential interactions and ensure it is safe for you to take this medication. 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. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
To minimize the risk of severe side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it. Be sure to discuss any new or worsening symptoms with your doctor.
Monitor your blood pressure regularly, as this medication can cause high blood pressure. Your doctor will advise you on the frequency of blood pressure checks.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or any prescription or over-the-counter drugs that may impair your actions, consult with your doctor.
Be aware that this medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
If you have bipolar disorder, be cautious of manic episodes while taking this medication. Immediately contact your doctor if you experience symptoms of a manic episode.
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 this risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
This medication can cause low blood sodium levels, which can be fatal in severe cases. Discuss this risk with your doctor.
High cholesterol has been associated with this medication. If you have concerns, consult with your doctor.
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
You may notice remnants of the medication in your stool, but this is normal and not a cause for concern.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
In some cases, this medication can affect growth in children and adolescents. They may require regular growth checks, so discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding. Taking this medication in mid to late pregnancy may lead to health problems in the mother, such as postpartum bleeding, or the newborn.
To minimize the risk of severe side effects, do not abruptly stop taking this medication without consulting your doctor. If you need to discontinue use, your doctor will guide you on how to gradually stop taking it. Be sure to discuss any new or worsening symptoms with your doctor.
Monitor your blood pressure regularly, as this medication can cause high blood pressure. Your doctor will advise you on the frequency of blood pressure checks.
Avoid consuming alcohol while taking this medication. Before using marijuana, cannabis, or any prescription or over-the-counter drugs that may impair your actions, consult with your doctor.
Be aware that this medication may increase the risk of bleeding, which can be life-threatening in some cases. Discuss this risk with your doctor.
If you have bipolar disorder, be cautious of manic episodes while taking this medication. Immediately contact your doctor if you experience symptoms of a manic episode.
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 this risk. If you experience eye pain, changes in vision, or swelling and redness in or around the eye, contact your doctor promptly.
This medication can cause low blood sodium levels, which can be fatal in severe cases. Discuss this risk with your doctor.
High cholesterol has been associated with this medication. If you have concerns, consult with your doctor.
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
You may notice remnants of the medication in your stool, but this is normal and not a cause for concern.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
In some cases, this medication can affect growth in children and adolescents. They may require regular growth checks, so discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the benefits and risks of taking this medication during pregnancy or breastfeeding. Taking this medication in mid to late pregnancy may lead to health problems in the mother, such as postpartum bleeding, or the newborn.
Overdose Information
Overdose Symptoms:
- Somnolence
- Mild to moderate tachycardia
- Hypotension or hypertension
- Mydriasis
- Nausea
- Vomiting
- Dizziness
- Convulsions
- ECG changes (e.g., QTc prolongation, bundle branch block, QRS prolongation)
- Coma
- Serotonin syndrome
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic. Ensure adequate airway, oxygenation, and ventilation. Activated charcoal may be considered if ingested recently. Monitor cardiac rhythm and vital signs. There is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - concurrent use or within 14 days of discontinuing an MAOI, or within 7 days of discontinuing venlafaxine before starting an MAOI (risk of serotonin syndrome)
Major Interactions
- Other serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's Wort) - increased risk of serotonin syndrome
- Drugs that inhibit CYP2D6 (e.g., quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels, potentially altering efficacy/safety
- Drugs that inhibit CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin) - may increase venlafaxine and ODV levels
- Warfarin - increased risk of bleeding
- Linezolid, Methylene Blue (IV) - risk of serotonin syndrome
Moderate Interactions
- Alcohol - additive CNS effects, impaired psychomotor skills
- Cimetidine - minor effect on venlafaxine/ODV pharmacokinetics
- Haloperidol - increased haloperidol AUC and Cmax
- Metoprolol - increased metoprolol AUC and Cmax (venlafaxine is a weak CYP2D6 inhibitor)
Minor Interactions
- Not specifically listed as minor, but general caution with other CNS depressants.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: Venlafaxine can cause dose-dependent increases in blood pressure.
Timing: Before initiating treatment
Heart Rate
Rationale: Can cause sustained increases in heart rate.
Timing: Before initiating treatment
Weight
Rationale: Monitor for significant weight changes.
Timing: Before initiating treatment
Serum Sodium
Rationale: Risk of hyponatremia, especially in elderly or those on diuretics.
Timing: Before initiating treatment, especially in at-risk patients
Cholesterol/Triglycerides
Rationale: Dose-dependent increases in serum cholesterol and triglycerides have been observed.
Timing: Before initiating treatment
Mental Status/Suicidal Ideation
Rationale: Assess baseline mood, anxiety, and suicidal thoughts, especially in young adults.
Timing: Before initiating treatment
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and periodically thereafter
Target: Within patient's normal range or target BP
Action Threshold: Sustained clinically significant elevation (e.g., >140/90 mmHg) may require dose reduction or discontinuation.
Heart Rate
Frequency: Periodically
Target: Within patient's normal range
Action Threshold: Sustained clinically significant tachycardia.
Weight
Frequency: Periodically
Target: Stable
Action Threshold: Significant or concerning weight loss/gain.
Serum Sodium
Frequency: Periodically, especially in elderly or those on diuretics
Target: 135-145 mEq/L
Action Threshold: <135 mEq/L (hyponatremia).
Cholesterol/Triglycerides
Frequency: Periodically, especially with long-term use
Target: Within normal limits
Action Threshold: Clinically significant elevations.
Mental Status/Suicidal Ideation
Frequency: Frequently during initial therapy (first few months) and dose changes, then periodically
Target: Improvement in target symptoms, absence of suicidal thoughts/behaviors
Action Threshold: Worsening depression, emergence of suicidal thoughts/behaviors, unusual changes in behavior.
Serotonin Syndrome Symptoms
Frequency: Ongoing, especially when co-administered with other serotonergic drugs
Target: Absence of symptoms
Action Threshold: Agitation, hallucinations, delirium, tachycardia, labile BP, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Symptoms of serotonin syndrome (e.g., agitation, confusion, rapid heart rate, sweating, muscle rigidity, tremors, fever, nausea, vomiting, diarrhea)
- Symptoms of hyponatremia (e.g., headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness, seizures)
- Symptoms of withdrawal (e.g., dizziness, nausea, headache, irritability, insomnia, vivid dreams, paresthesias, anxiety, sweating, tremor) upon discontinuation or dose reduction
- New or worsening anxiety
- Visual disturbances (e.g., mydriasis, narrow-angle glaucoma)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. Venlafaxine is a Pregnancy Category C drug. Exposure during late pregnancy may lead to complications in the neonate.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major malformations. Risk of cardiac defects cannot be definitively ruled out.
Second Trimester:
No specific increased risks identified beyond general antidepressant use.
Third Trimester:
Risk of neonatal withdrawal syndrome (poor feeding, irritability, respiratory distress, tremors, seizures) and persistent pulmonary hypertension of the newborn (PPHN).
Lactation
Venlafaxine and its active metabolite (ODV) are excreted into breast milk. The decision to breastfeed should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for Effexor XR, and any potential adverse effects on the breastfed infant from Effexor XR or from the underlying maternal condition.
Infant Risk:
L3 (Moderately Safe). Monitor breastfed infants for sedation, poor feeding, weight loss, and developmental milestones. Some infants may experience adverse effects, while others may not. Consider alternative agents with more safety data if possible.
Pediatric Use
Not approved for use in pediatric patients. A Black Box Warning exists regarding increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (18-24 years of age) with MDD and other psychiatric disorders. Use in this population should be carefully weighed against the risks.
Geriatric Use
No overall differences in safety or efficacy were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for hyponatremia and falls. Lower starting doses and slower titration may be considered.
Clinical Information
Clinical Pearls
- Effexor XR should be taken with food to minimize gastrointestinal upset and improve tolerability.
- Do not crush or chew the extended-release capsules; they are designed for once-daily dosing.
- Patients should be advised about the importance of not abruptly discontinuing venlafaxine due to the high risk of withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia). Tapering should be gradual over several weeks.
- Monitor blood pressure regularly, especially during dose escalation, as venlafaxine can cause dose-dependent hypertension.
- Be vigilant for symptoms of serotonin syndrome, particularly when co-administered with other serotonergic agents.
- The active metabolite, O-desmethylvenlafaxine (ODV), is also available as a separate drug (Pristiq), which may be considered for patients with CYP2D6 poor metabolizer status, though clinical significance is often minor.
- Patients should be screened for a history of bipolar disorder before initiating venlafaxine due to the risk of inducing mania/hypomania.
Alternative Therapies
- SSRIs (e.g., escitalopram, sertraline, fluoxetine, paroxetine, citalopram) for MDD, GAD, SAD, PD
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, nortriptyline) for MDD
- Bupropion (Wellbutrin) for MDD
- Mirtazapine (Remeron) for MDD
- Cognitive Behavioral Therapy (CBT)
- Other psychotherapies
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.