Venlafaxine ER 75mg Tablets
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 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
Jun 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Venlafaxine ER is an antidepressant medication that works by affecting certain natural chemicals in the brain (serotonin and norepinephrine) that help regulate mood. It's used to treat depression, anxiety disorders, and panic disorder. The 'ER' means extended-release, so it's taken once a day.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Important Administration Instructions
Swallow your medication whole; do not chew, break, or crush it.
Take your medication with a full glass of water.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and 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 way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular 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 these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Important Administration Instructions
Swallow your medication whole; do not chew, break, or crush it.
Take your medication with a full glass of water.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and 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 way to dispose of your medication, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular 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 tablet whole; do not crush, chew, or divide.
- Avoid alcohol, as it can increase side effects.
- Be cautious when driving or operating machinery until you know how the medication affects you, as it can cause dizziness or drowsiness.
- Do not stop taking this medication suddenly without consulting your doctor, as it can lead to withdrawal symptoms.
- Inform your doctor about all other medications, supplements, and herbal products you are taking, especially St. John's Wort or other antidepressants.
Available Forms & Alternatives
Available Strengths:
- Venlafaxine 50mg Tablets
- Venlafaxine 37.5mg Tablets
- Venlafaxine 25mg Tablets
- Venlafaxine 75mg Tablets
- Venlafaxine 100mg Tablets
- Venlafaxine ER 37.5mg Capsules
- Venlafaxine ER 150mg Capsules
- Venlafaxine ER 75mg Capsules
- Venlafaxine ER 37.5mg Capsules
- Venlafaxine ER 37.5mg Capsules
- Venlafaxine ER 150mg Capsules
- Venlafaxine ER 150mg Capsules
- Venlafaxine ER 75mg Tablets
- Venlafaxine ER 150mg Tablets
- Venlafaxine ER 225mg Tablets
- Venlafaxine ER 37.5mg Tablets
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. Max: 225 mg/day.
Generalized Anxiety Disorder (GAD):
Initial: 75 mg once daily. May increase by 75 mg/day increments at intervals of 4 days or more, up to 225 mg/day. Max: 225 mg/day.
Social Anxiety Disorder (SAD):
Initial: 75 mg once daily. Max: 75 mg/day (no additional benefit shown at higher doses).
Panic Disorder (PD):
Initial: 37.5 mg once daily for 7 days, then increase to 75 mg once daily. May increase by 75 mg/day increments at intervals of 7 days or more, up to 225 mg/day. Max: 225 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients <18 years for MDD, GAD, SAD, PD. Use in pediatric patients for MDD is not recommended due to lack of efficacy and increased risk of suicidality.)
Adolescent:
Not established (Safety and efficacy not established in pediatric patients <18 years for MDD, GAD, SAD, PD. Use in pediatric patients for MDD is not recommended due to lack of efficacy and increased risk of suicidality.)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl 60-90 mL/min)
Moderate:
Reduce total daily dose by 25% (CrCl 30-60 mL/min)
Severe:
Reduce total daily dose by 50% (CrCl <30 mL/min)
Dialysis:
Reduce total daily dose by 50% and administer after dialysis session.
Hepatic Impairment:
Mild:
Reduce total daily dose by 50% (Child-Pugh A)
Moderate:
Reduce total daily dose by 50% (Child-Pugh B)
Severe:
Reduce total daily dose by 50% (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. The antidepressant and anxiolytic effects are believed to be associated with potentiation of neurotransmitter activity in the CNS.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 45% (due to presystemic metabolism)
Tmax:
Venlafaxine: 5.5 hours; ODV: 9 hours (for ER formulation)
FoodEffect:
Food has no significant effect on the absorption or extent of venlafaxine or ODV.
Distribution:
Vd:
Venlafaxine: 7.5 L/kg; ODV: 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:
Renal (approximately 87% of a dose is excreted in the urine within 48 hours, primarily as ODV and its glucuronide, and N-desmethylvenlafaxine)
Unchanged:
Approximately 5% of venlafaxine and 29% of ODV are excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Typically 1-2 weeks for initial therapeutic effects; full effects may take 4-6 weeks.
PeakEffect:
Not directly quantifiable for clinical effect, but steady-state plasma concentrations are achieved within 3 days for venlafaxine and 4 days for ODV with multiple dosing.
DurationOfAction:
24 hours (due to extended-release formulation and half-life of active metabolite)
Safety & Warnings
BLACK BOX WARNING
Antidepressants increased the risk compared to placebo of suicidal thoughts 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 venlafaxine 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 age 24; 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 or seek immediate 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, trouble focusing, memory problems, feeling confused, 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 uncontrolled 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
Sex 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 when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid 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 medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Sleep disturbances
Feeling nervous or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Vivid or unusual dreams
Yawning
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 or seek immediate 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, trouble focusing, memory problems, feeling confused, 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 uncontrolled 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
Sex 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 when taking certain other medications. Seek immediate medical attention if you experience:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Rapid 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 medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:
Sleep disturbances
Feeling nervous or excitable
Anxiety
Weight loss
Dizziness, drowsiness, fatigue, or weakness
Shakiness
Headache
Excessive sweating
Constipation, diarrhea, stomach pain, nausea, vomiting, or decreased appetite
Gas
Dry mouth
Vivid or unusual dreams
Yawning
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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 suicidal thoughts, especially at the beginning of treatment or after a dose change.
- Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.
- New or worsening high blood pressure.
- Eye pain, changes in vision, or swelling or redness in or around the eye (may indicate angle-closure glaucoma).
- Unusual bleeding or bruising.
- Seizures.
- Symptoms of mania/hypomania: increased energy, severe insomnia, racing thoughts, reckless behavior, extreme happiness or irritability.
- Severe allergic reaction (rash, hives, difficulty breathing, swelling of face/lips/tongue/throat).
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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 taking a weight loss drug, as interactions may occur.
If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these drugs can interact with this 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 together 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
Share your complete medical history and list of medications to ensure it is safe to take this medication. Do not 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
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 taking a weight loss drug, as interactions may occur.
If you are taking or have recently taken certain medications, including:
+ Linezolid or methylene blue, as these drugs can interact with this 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 together 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
Share your complete medical history and list of medications to ensure it is safe to take this medication. Do not 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 any 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. Stopping the medication suddenly may increase your risk of side effects, which can be severe and long-lasting. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it. 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.
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 have any concerns.
If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience any 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 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 concerns.
High cholesterol has been associated with this medication. If you have questions or concerns, consult your doctor.
This medication may affect 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 the tablet shell in your stool, but this is normal and not a cause for concern. 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, so discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. 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 of taking this medication during pregnancy or breastfeeding.
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. Stopping the medication suddenly may increase your risk of side effects, which can be severe and long-lasting. If you need to discontinue the medication, your doctor will guide you on how to gradually stop taking it. 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.
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 have any concerns.
If you have bipolar disorder, be aware that this medication may trigger manic episodes. Contact your doctor immediately if you experience any 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 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 concerns.
High cholesterol has been associated with this medication. If you have questions or concerns, consult your doctor.
This medication may affect 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 the tablet shell in your stool, but this is normal and not a cause for concern. 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, so discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. 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 of taking this medication during pregnancy or breastfeeding.
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. Ensure adequate airway, oxygenation, and ventilation. Activated charcoal may be considered if ingested recently.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - risk of serious, sometimes fatal, serotonin syndrome. Do not use within 14 days of discontinuing an MAOI, or initiate an MAOI within 7 days of discontinuing venlafaxine.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, other SNRIs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) - increased risk of serotonin syndrome.
- Linezolid, Methylene Blue (IV) - risk of serotonin syndrome.
- Drugs that impair metabolism of venlafaxine (e.g., strong CYP2D6 inhibitors like quinidine, fluoxetine, paroxetine) - may increase venlafaxine levels and decrease ODV levels, potentially altering efficacy/safety.
- Drugs that affect hemostasis (e.g., NSAIDs, aspirin, warfarin) - increased risk of bleeding.
Moderate Interactions
- Cimetidine - may inhibit first-pass metabolism of venlafaxine, increasing AUC.
- Haloperidol - venlafaxine may increase haloperidol AUC and Cmax.
- Clozapine - elevated clozapine levels and associated adverse reactions (e.g., seizures) have been reported.
- Metoprolol - venlafaxine may increase metoprolol plasma levels.
- Indinavir - venlafaxine may decrease indinavir AUC and Cmax.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Rationale: Venlafaxine can cause dose-related increases in BP and HR.
Timing: Prior to initiation
Weight
Rationale: Monitor for significant weight changes.
Timing: Prior to initiation
Psychiatric Assessment (mood, anxiety symptoms, suicidal ideation)
Rationale: Establish baseline for treatment efficacy and safety monitoring.
Timing: Prior to initiation
Glaucoma screening (if risk factors present)
Rationale: Risk of mydriasis and angle-closure glaucoma.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP) and Heart Rate (HR)
Frequency: Regularly, especially during dose titration and periodically thereafter.
Target: Maintain within normal limits or patient's baseline.
Action Threshold: Persistent or clinically significant hypertension/tachycardia; consider dose reduction or alternative treatment.
Weight
Frequency: Periodically
Target: Maintain stable weight.
Action Threshold: Clinically significant weight gain or loss.
Mental Status (mood, anxiety, suicidal ideation, emergence of new or worsening psychiatric symptoms, agitation, mania/hypomania)
Frequency: Regularly, especially during initial therapy and dose changes.
Target: Improvement in target symptoms without emergence of adverse psychiatric effects.
Action Threshold: Worsening depression, suicidality, agitation, or manic symptoms; consider dose adjustment or discontinuation.
Serotonin Syndrome symptoms (agitation, hallucinations, tachycardia, labile BP, hyperthermia, hyperreflexia, incoordination, N/V/D)
Frequency: Ongoing, especially when co-administered with other serotonergic agents.
Target: Absence of symptoms.
Action Threshold: Any signs of serotonin syndrome; discontinue venlafaxine and provide supportive care.
Bleeding (e.g., bruising, petechiae, GI bleeding)
Frequency: Ongoing, especially with concomitant use of antiplatelet agents or anticoagulants.
Target: Absence of abnormal bleeding.
Action Threshold: Any signs of abnormal bleeding; investigate and manage appropriately.
Symptom Monitoring
- Worsening depression
- Suicidal thoughts or behavior
- Unusual changes in behavior (e.g., agitation, irritability, aggression, panic attacks, insomnia, impulsivity, akathisia, hypomania, mania)
- Serotonin syndrome (e.g., agitation, confusion, rapid heart rate, sweating, muscle rigidity, tremors, nausea, vomiting, diarrhea)
- Hypertension
- Tachycardia
- Mydriasis (pupil dilation)
- Visual disturbances (especially eye pain, redness, swelling around the eye)
- Abnormal bleeding or bruising
- Seizures
- Hyponatremia (headache, confusion, weakness, seizures)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if 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. These complications can arise immediately upon delivery and are consistent with a direct toxic effect of SSRIs/SNRIs or a drug discontinuation syndrome.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally not associated with major congenital malformations.
Second Trimester:
Not available
Third Trimester:
Increased risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome (e.g., respiratory distress, cyanosis, apnea, seizures, feeding difficulty, irritability, tremor, hypotonia, hypertonia, hyperreflexia, vomiting, hypoglycemia).
Lactation
Venlafaxine and 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 venlafaxine, and any potential adverse effects on the breastfed infant from venlafaxine or from the underlying maternal condition. Monitor breastfed infants for sedation, poor feeding, and poor weight gain.
Infant Risk:
Moderate risk (L3). Monitor for sedation, poor feeding, and weight gain. Some infants may experience mild adverse effects.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Antidepressants, including venlafaxine, increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults (ages 18-24) compared to placebo. Use in pediatric patients for MDD is not recommended.
Geriatric Use
No overall differences in effectiveness were observed between geriatric and younger patients. However, geriatric patients may be more sensitive to the effects of venlafaxine, particularly hyponatremia and dose-related increases in blood pressure. Renal and hepatic impairment are more common in the elderly, requiring dose adjustments.
Clinical Information
Clinical Pearls
- Venlafaxine ER should be taken with food to minimize GI upset and improve tolerability.
- Swallow the capsule/tablet whole; do not crush, chew, or divide. The capsule contains beads that release the medication slowly.
- Monitor blood pressure regularly, especially during dose escalation, as venlafaxine can cause sustained hypertension.
- Taper venlafaxine slowly when discontinuing to avoid severe withdrawal symptoms (e.g., dizziness, nausea, headache, paresthesias, anxiety, insomnia). A gradual reduction over several weeks is recommended.
- Be aware of the risk of serotonin syndrome, especially when co-prescribing with other serotonergic agents.
- Patients should be advised about the potential for pupil dilation (mydriasis) and the risk of angle-closure glaucoma, especially if they have pre-existing narrow angles.
Alternative Therapies
- Other SNRIs (e.g., Duloxetine, Desvenlafaxine, Levomilnacipran)
- SSRIs (e.g., Fluoxetine, Sertraline, Paroxetine, Citalopram, Escitalopram)
- Atypical antidepressants (e.g., Bupropion, Mirtazapine, Vortioxetine, Vilazodone)
- Tricyclic Antidepressants (TCAs) (e.g., Amitriptyline, Nortriptyline)
- MAOIs (e.g., Phenelzine, Tranylcypromine, Selegiline - generally reserved for refractory cases due to significant drug-drug and food-drug interactions)
Cost & Coverage
Average Cost:
$30 - $150 per 30 tablets (75mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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. It is essential to 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 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 quantity, and the time it was taken.
This medication is accompanied by a Medication Guide, which provides crucial information for patients. It is essential to 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 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 quantity, and the time it was taken.