Quick answers
- What is Venlafaxine hydrochloride used for?
- The FDA-approved label (Venlafaxine Hydrochloride, Advagen Pharma Ltd., August 25, 2026) says: “Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of: Major Depressive Disorder (MDD) […] Generalized Anxiety Disorder (GAD) […] Social Anxiety Disorder (SAD) […] Panic Disorder (PD) […] Venlafaxine hydrochloride extended-release capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Venlafaxine hydrochloride?
- The “Adverse Reactions” section of the FDA label (Venlafaxine Hydrochloride, Advagen Pharma Ltd., August 25, 2026) begins: “The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Elevated Blood Pressure [see Warnings and Precautions (5.3)] Increased Risk of Bleeding [see Warnings and Precautions (5.4)] Angle-Closure Glaucoma [see Warnings and Precautions …” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Venlafaxine hydrochloride?
- The “Drug Interactions” section of the FDA label (Venlafaxine Hydrochloride, Advagen Pharma Ltd., August 25, 2026) begins: “Drugs Having Clinically Important Interactions with Venlafaxine hydrochloride extended-release capsules Table 15: Clinically Important Drug Interactions with Venlafaxine hydrochloride extended-release capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including venlafaxine hydrochloride extended-release capsules, with MAOIs increases the risk of serotonin syndrome.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Venlafaxine hydrochloride have a boxed warning?
- Yes. The FDA label for Venlafaxine Hydrochloride has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Venlafaxine hydrochloride?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Venlafaxine hydrochloride been recalled?
- FDA enforcement reports list 8 recalls of products of this medicine; the newest started March 21, 2025 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Venlafaxine hydrochloride?
- 59 companies list prescription products of Venlafaxine hydrochloride in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Remedyrepack Inc.
What Venlafaxine hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Venlafaxine hydrochloride extended-release capsules is indicated in adults for the treatment of: Major Depressive Disorder (MDD) […] Generalized Anxiety Disorder (GAD) […] Social Anxiety Disorder (SAD) […] Panic Disorder (PD) […] Venlafaxine hydrochloride extended-release capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with …
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (capsule, extended release, oral), Venlafaxine Hydrochloride, Advagen Pharma Ltd.; it covers 4 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 176 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
. Read it on the full label →
171 of 176 FDA labels for this medicine have a boxed warning.
Venlafaxine hydrochloride boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)]. Venlafaxine hydrochloride extended-release capsules is not approved for use in pediatric patients [see Use in Specific Populations (8.4)].
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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric patients and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1). Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients (8.4).
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. Read the full label on DailyMed →
Venlafaxine hydrochloride side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see Contraindications (4)] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)] Serotonin Syndrome [see Warnings and Precautions (5.2)] Elevated Blood Pressure [see Warnings and Precautions (5.3)] Increased Risk of Bleeding [see Warnings and Precautions (5.4)] Angle-Closure Glaucoma [see Warnings and Precautions …
Table from the label
| Body System Adverse Reaction | Venlafaxine hydrochloride extended-release capsules n = 3,558 | Placebo n = 2,197 |
|---|---|---|
| Body as a whole | ||
| Asthenia | 1.7 | 0.5 |
| Headache | 1.5 | 0.8 |
| Digestive system | ||
| Nausea | 4.3 | 0.4 |
| Nervous system | ||
| Dizziness | 2.2 | 0.8 |
| Insomnia | 2.1 | 0.6 |
| Somnolence | 1.7 | 0.3 |
| Skin and appendages | 1.5 | 0.6 |
| Sweating | 1.0 | 0.2 |
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →
Venlafaxine hydrochloride drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Drugs Having Clinically Important Interactions with Venlafaxine hydrochloride extended-release capsules Table 15: Clinically Important Drug Interactions with Venlafaxine hydrochloride extended-release capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including venlafaxine hydrochloride extended-release capsules, with MAOIs increases the risk of serotonin syndrome.
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Intervention Concomitant use of venlafaxine hydrochloride extended-release capsules are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.11), Contraindications (4) and Warnings and Precautions (5.2)] Other Serotonergic Drugs Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when venlafaxine hydrochloride extended-release capsules is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of venlafaxine hydrochloride extended-release capsules and/or concomitant serotonergic drugs [see Dosage and Administration (2.11) and Warnings and Precautions (5.2)]. Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of venlafaxine hydrochloride extended-release capsules on the release of serotonin by platelets. Intervention Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when venlafaxine hydrochloride extended-release capsules is initiated or discontinued [see Warnings and Precautions (5.4)]. Effect of CYP3A Inhibitors Clinical Impact Concomitant use of a CYP3A inhibitor increases the C max and AUC of venlafaxine and O-desmethylvenlafaxine (ODV) [see Clinical Pharmacology (12.3)], which may increase the risk of toxicity of venlafaxine hydrochloride extended-release capsules Intervention Consider reducing the dose of venlafaxine hydrochloride extended-release capsules. CYP2D6 Substrates Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules increases C max and AUC of a CYP2D6 substrate, which may increase the risk of toxicity of the CYP2D6 substrate [see Clinical Pharmacology (12.3)]. Intervention Consider reduction in dose of concomitant CYP2D6 substrates. 7.2 Other Drug Interactions with Venlafaxine hydrochloride extended-release capsules Central Nervous System (CNS)-Active Drugs The risk of using venlafaxine concomitantly with other CNS-active drugs (including alcohol) has not been systematically evaluated. Consequently, caution is advised when venlafaxine hydrochloride extended-release capsules is taken concomitantly in combination with other CNS-active drugs.
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →
Venlafaxine hydrochloride dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Indication Starting Dose Target Dose Maximum Dose MDD (2.2) 37.5-75 mg/day 75 mg/day 225 mg/day GAD (2.3) 37.5-75 mg/day 75 mg/day 225 mg/day SAD (2.4) 75 mg/day 75 mg/day 75 mg/day PD (2.5) 37.5 mg/day 75 mg/day 225 mg/day Take once daily with food. Capsules should be taken whole; do not divide, crush, chew, or dissolve (2.1). When discontinuing treatment, reduce the dose gradually (2.10, 5.7).
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Renal impairment: Reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment (2.9). Hepatic impairment: Reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% (2.8). 2.1 General Administration Information Administer venlafaxine hydrochloride extended-release capsules as a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3)]. Swallow capsules whole with fluid. Do not divide, crush, chew, or place in water. The capsule may also be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets (spheroids). 2.2 Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more. 2.3 Generalized Anxiety Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day. Dose increases should be in increments of up to 75 mg per day, as needed, and should be made at intervals of not less than 4 days. 2.4 Social Anxiety Disorder (Social Phobia) The recommended dose is 75 mg per day, administered in a single dose. There was no evidence that higher doses confer any additional benefit. 2.5 Panic Disorder The recommended starting dose is 37.5 mg per day of venlafaxine hydrochloride extended-release capsules for 7 days.
Table from the label
| Indication | Starting Dose | Target Dose | Maximum Dose |
|---|---|---|---|
| MDD (2.2) | 37.5-75 mg/day | 75 mg/day | 225 mg/day |
| GAD (2.3) | 37.5-75 mg/day | 75 mg/day | 225 mg/day |
| SAD (2.4) | 75 mg/day | 75 mg/day | 75 mg/day |
| PD (2.5) | 37.5 mg/day | 75 mg/day | 225 mg/day |
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. This is part of the section. Read the full label on DailyMed →
When Venlafaxine hydrochloride should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Venlafaxine hydrochloride extended-release capsules is contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2)]. taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration (2.11), Warnings and Precautions (5.2), and Drug Interactions (7.1)].
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Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Venlafaxine hydrochloride extended-release capsules formulation (4). Concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI (4, 5.2, 7.1).
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. Read the full label on DailyMed →
Venlafaxine hydrochloride overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Human Experience During the premarketing evaluations of venlafaxine hydrochloride extended-release capsules (for MDD, GAD, SAD, and PD) and venlafaxine hydrochloride tablets (for MDD), there were twenty reports of acute overdosage with venlafaxine hydrochloride tablets (6 and 14 reports in venlafaxine hydrochloride extended-release capsules and venlafaxine hydrochloride tablets patients, respectively), either alone or in combination with other drugs and/or alcohol.
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Somnolence was the most commonly reported symptom. Among the other reported symptoms were paresthesia of all four limbs, moderate dizziness, nausea, numb hands and feet, and hot-cold spells 5 days after the overdose. In most cases, no signs or symptoms were associated with overdose. The majority of the reports involved ingestion in which the total dose of venlafaxine taken was estimated to be no more than several-fold higher than the usual therapeutic dose. One patient who ingested 2.75 g of venlafaxine was observed to have two generalized convulsions and a prolongation of QTc to 500 msec, compared with 405 msec at baseline. Mild sinus tachycardia was reported in two of the other patients. Actions taken to treat the overdose included no treatment, hospitalization and symptomatic treatment, and hospitalization plus treatment with activated charcoal. All patients recovered. In postmarketing experience, overdose with venlafaxine has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported. Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher preexisting burden of suicide risk factors than SSRI-treated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage, as opposed to some characteristic(s) of venlafaxine-treated patients, is not clear. Prescriptions for venlafaxine hydrochloride extended-release capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Management of Overdosage No specific antidotes for venlafaxine hydrochloride extended-release capsules are known. In managing overdosage, consider the possibility of multiple drug involvement. Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for overdosage management recommendations for venlafaxine hydrochloride extended-release capsules.
— FDA label: Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Capsule, extended release · Tablet · Tablet, extended release · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 334 in the FDA NDC Directory |
| Brand names | Effexor XR |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| venlafaxine hydrochloride 100 mg tablet | Generic | $0.1204 per tablet |
| venlafaxine hydrochloride 150 mg capsule, extended release | Generic | $0.1225 per capsule |
| venlafaxine hydrochloride 150 mg capsule, extended release | Brand: Effexor XR | $21.62 per capsule |
| venlafaxine hydrochloride 150 mg tablet | Generic | $0.2256 per tablet |
| venlafaxine hydrochloride 150 mg tablet, coated | Generic | $0.2256 per tablet |
| venlafaxine hydrochloride 150 mg tablet, extended release | Generic | $0.2256 per tablet |
| venlafaxine hydrochloride 225 mg tablet | Generic | $0.4740 per tablet |
| venlafaxine hydrochloride 225 mg tablet, coated | Generic | $0.4740 per tablet |
| venlafaxine hydrochloride 225 mg tablet, extended release | Generic | $0.4740 per tablet |
| venlafaxine hydrochloride 25 mg tablet | Generic | $0.0713 per tablet |
| venlafaxine hydrochloride 37.5 mg capsule, extended release | Generic | $0.0791 per capsule |
| venlafaxine hydrochloride 37.5 mg capsule, extended release | Brand: Effexor XR | $17.72 per capsule |
| venlafaxine hydrochloride 37.5 mg tablet | Generic | $0.0741 per tablet |
| venlafaxine hydrochloride 37.5 mg tablet, extended release | Generic | $0.3048 per tablet |
| venlafaxine hydrochloride 50 mg tablet | Generic | $0.0849 per tablet |
| venlafaxine hydrochloride 75 mg capsule, extended release | Generic | $0.0801 per capsule |
| venlafaxine hydrochloride 75 mg capsule, extended release | Brand: Effexor XR | $19.81 per capsule |
| venlafaxine hydrochloride 75 mg tablet | Generic | $0.0861 per tablet |
| venlafaxine hydrochloride 75 mg tablet, coated | Generic | $0.2901 per tablet |
| venlafaxine hydrochloride 75 mg tablet, extended release | Generic | $0.2901 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- A-S Medication Solutions22 products
- Bryant Ranch Prepack19 products
- Remedyrepack Inc.19 products
- Zydus Pharmaceuticals USA Inc.15 products
- Zydus Lifesciences Limited15 products
- NuCare Pharmaceuticals, Inc.14 products
- Proficient Rx LP11 products
- Rising Pharma Holdings, Inc.9 products
- BluePoint Laboratories9 products
- Sun Pharmaceutical Industries, Inc.9 products
- Cadila Pharmaceuticals Limited8 products
- Teva Pharmaceuticals USA, Inc.8 products
- Alembic Pharmaceuticals Limited8 products
- Aurobindo Pharma Limited8 products
- Preferred Pharmaceuticals Inc.8 products
- Alembic Pharmaceuticals Inc.8 products
- Camber Pharmaceuticals, Inc.7 products
- American Health Packaging6 products
- Coupler LLC6 products
- Advanced Rx of Tennessee, LLC6 products
- Advanced Rx Pharmacy of Tennessee, LLC5 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.5 products
- Yaopharma Co., Ltd.5 products
- Dr. Reddy's Laboratories Limited5 products
- Golden State Medical Supply, Inc.5 products
- Northwind Health Company, LLC5 products
- Ajanta Pharma USA Inc.4 products
- XLCare Pharmaceuticals, Inc.4 products
- Advagen Pharma Ltd4 products
- Ascend Laboratories, LLC4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- Quallent Pharmaceuticals Health LLC3 products
- Macleods Pharmaceuticals Limited3 products
- AvKARE3 products
- AvPAK3 products
- Dr.Reddy's Laboratories Ltd.3 products
- St. Mary's Medical Park Pharmacy3 products
- Nivagen Pharmaceuticals, Inc.3 products
- Asclemed USA, Inc.3 products
- Epic Pharma, LLC3 products
- Viatris Specialty LLC3 products
- Annora Pharma Private Limited3 products
- Marlex Pharmaceuticals, Inc.3 products
- Puracap Laboratories LLC dba Blu Pharmaceuticals3 products
- NorthStar RxLLC3 products
- Granules Pharmaceuticals Inc.3 products
- Major Pharmaceuticals3 products
- Dr.Reddys Laboratories Inc3 products
- Modavar Pharmaceuticals LLC3 products
- Direct_Rx2 products
- QPharma, Inc.2 products
- Edenbridge Pharmaceuticals LLC.2 products
- Dr. Reddy's Laboratories Inc.2 products
- Westminster Pharmaceuticals, LLC2 products
- Cardinal Health 107, LLC1 product
- Trigen Laboratories, LLC1 product
- Chartwell RX, LLC1 product
- Aphena Pharma Solutions - Tennessee, LLC1 product
- PD-Rx Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020699 EFFEXOR XR | Upjohn | October 20, 1997 | 79, latest August 18, 2023 2023: Labeling · 2022: Labeling · 2021: Labeling |
| NDA022104 VENLAFAXINE HYDROCHLORIDE | Osmotica Pharm Us | May 20, 2008 | 13, latest August 18, 2023 2023: Labeling · 2021: Labeling · 2017: Labeling |
Generic approvals (30)
- ANDA076690Teva · August 3, 2006
- ANDA077653Zydus Pharms USA · June 13, 2008
- ANDA078301DR Reddys Labs Ltd · June 13, 2008
- ANDA078627Sun Pharm Inds Inc · June 13, 2008
- ANDA078554Heritage · January 9, 2009
- ANDA090555Aurobindo Pharma · April 7, 2010
- ANDA076565Teva · June 28, 2010
- ANDA091272Sun Pharm · August 18, 2010
- ANDA078932Alembic Pharms Ltd · December 14, 2010
- ANDA090174Zydus Pharms USA Inc · April 14, 2011
- ANDA200834Aurobindo Pharma Ltd · April 14, 2011
- ANDA078421DR Reddys Labs Ltd · May 6, 2011
- ANDA202036Yaopharma Co Ltd · May 28, 2015
- ANDA205468Mpp Pharma · March 24, 2017
- ANDA204889Macleods Pharms · October 5, 2017
- ANDA206250Cadila Pharms Ltd · November 21, 2018
- ANDA201272Platinum · November 23, 2018
- ANDA212277Annora Pharma · July 8, 2019
- ANDA211323Cadila Pharms Ltd · August 29, 2019
- ANDA209193Adaptis · October 31, 2019
- ANDA203332Adaptis · March 12, 2020
- ANDA214419Ascent Pharms Inc · October 21, 2020
- ANDA214127Alkem Labs Ltd · June 10, 2021
- ANDA214609Somerset Theraps LLC · June 30, 2021
- ANDA214654Yichang Humanwell · August 6, 2021
- ANDA215622Zydus Pharms · August 30, 2022
- ANDA216044Unique · November 28, 2022
- ANDA214691Ajanta Pharma Ltd · April 12, 2023
- ANDA217390Granules · May 18, 2023
- ANDA217767Alembic · June 6, 2024
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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March 21, 2025 · Class II · Completed · D-0310-2025
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01. — Zydus Pharmaceuticals (USA) Inc
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January 16, 2025 · Class III · Completed · D-0208-2025
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90. — Appco Pharma LLC
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June 21, 2024 · Class II · Terminated · D-0617-2024
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; — Zydus Pharmaceuticals (USA) Inc
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December 22, 2016 · Class II · Terminated · D-0474-2017
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyder — Aurobindo Pharma USA Inc
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July 19, 2016 · Class II · Terminated · D-1460-2016
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c) 1000-count bottles, (NDC 68382-036-10), Rx only, Manufactured by : Cadila Healthca — Zydus Pharmaceuticals USA Inc
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July 19, 2016 · Class II · Terminated · D-1461-2016
Failed Dissolution Specifications: out of specification dissolution results in retained samples
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) 1000-count bottles, (NDC 68382-035-10), Rx only, Manufactured by : Cadila Healthcar — Zydus Pharmaceuticals USA Inc
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March 25, 2016 · Class III · Terminated · D-0837-2016
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch. — Bryant Ranch Prepack Inc.
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March 5, 2013 · Class II · Terminated · D-202-2013
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382 — Zydus Pharmaceuticals USA Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Venlafaxine Hydrochloride, Advagen Pharma Ltd., effective August 25, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →