Prescription medicine
Venlafaxine Brand names: Effexor
Venlafaxine (Effexor) is a prescription medicine with an FDA approval on record since 1993. FDA's NDC Directory lists it from 61 generic labelers, and pharmacies paid $0.0799 per venlafaxine HCl ER 75 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the venlafaxine FDA label on DailyMed (effective August 15, 2023, Viatris Specialty LLC); the NDA 20151 record on Drugs@FDA; every venlafaxine label on DailyMed.
Highlights of the record
FDA label of August 15, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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) ]. Effexor XR is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. 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 ).
Effexor XR is not approved for use in pediatric patients ( 8.4 ).
Used for
From the label: indications and usageEffexor XR is indicated in adults for the treatment of:
Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ]
Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ]
Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ]
Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:
Forms and strengths
- 25 mg
- 37.5 mg
- 50 mg
- 75 mg
- 100 mg
- 112.5 mg
- 150 mg
- 225 mg
Extended-release capsule; tablet; extended-release tablet; coated tablet.
On the market
- Earliest approval on file
- December 28, 1993 Effexor, Wyeth Pharms Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 45 first August 3, 2006; 32 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 64 of which 61 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 16, 2028 Venlafaxine Besylate tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0799 per capsule Venlafaxine HCl ER 75 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 21 since 2012 1 Class I among all firms' recalls; latest March 21, 2025; 6 more by firms not listed as its makers
- FAERS reports
- 131,560 through July 30, 2026
What is venlafaxine used for?
From the label: indications and usageEffexor XR is indicated in adults for the treatment of:
Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ]
Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ]
Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ]
Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with:
Major Depressive Disorder (MDD) ( 1 )
Generalized Anxiety Disorder (GAD) ( 1 )
Social Anxiety Disorder (SAD) ( 1 )
Panic Disorder (PD)
Conditions named in the indications of venlafaxine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (Effexor XR), NDA020699 (Upjohn), as published by Viatris Specialty LLC, effective August 15, 2023 (SPL set c848a5d8-ba94-4c84-80e3-0bf35fb8e32e), via openFDA; the full label on DailyMed
What does the patient leaflet for venlafaxine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EFFEXOR XR?EFFEXOR XR may cause serious side effects, including: • Increased risk of suicidal thoughts and actions. EFFEXOR XR and other antidepressant medicines may increase suicidal thoughts and actions in some children, adolescents, and young adults, especially within the first few months of treatment or when the dose is changed. EFFEXOR XR is not for use in children. o Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? o Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you or a family member have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • acting aggressive, being angry, or violent • new or worse depression • panic attacks • new or worse irritability • an extreme increase in activity or talking (mania) • thoughts about suicide or dying • acting on dangerous impulses • new or worse anxiety • feeling very agitated or restless • trouble sleeping • other unusual changes in behavior or mood
From the patient leaflet: What should I avoid while taking EFFEXOR XR?Do not drive, or operate heavy machinery, or do other dangerous activities until you know how EFFEXOR XR affects you. EFFEXOR XR can make you drowsy. • You should not drink alcohol during treatment with EFFEXOR XR. Drinking alcohol during treatment with EFFEXOR XR can increase your risk of having serious side effects.
From the patient leaflet: How should I store EFFEXOR XR?Store EFFEXOR XR at room temperature between 68°F to 77°F (20°C to 25°C). • Keep EFFEXOR XR in a dry place. Keep EFFEXOR XR and all medicines out of the reach of children.
Source: FDA drug label (Effexor XR), NDA020699 (Upjohn), as published by Viatris Specialty LLC, effective August 15, 2023 (SPL set c848a5d8-ba94-4c84-80e3-0bf35fb8e32e), via openFDA; the full label on DailyMed
Is there a generic for venlafaxine (Effexor)?
The FDA approved the first generic venlafaxine on August 3, 2006. 45 generic applications are approved; 32 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists venlafaxine from 61 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Effexor XR capsules; a patent listed only for Venlafaxine Besylate tablets runs to May 16, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1993 earliest approval on file
- 2006 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for venlafaxine (Effexor)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0799 per Venlafaxine HCl ER 75 mg capsule, down 13% from $0.0921 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Venlafaxine HCl ER 75 mg capsule (generic)
- Effexor XR 37.5 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Venlafaxine bes ER 112.5 mg tablet | Generic | $6.23 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $186.90 | +0.6% |
| Venlafaxine HCl 100 mg tablet | Generic | $0.110 per tablet | $3.30 | -7% |
| Venlafaxine HCl 25 mg tablet | Generic | $0.0723 per tablet | $2.17 | -11% |
| Venlafaxine HCl 37.5 mg tablet | Generic | $0.0714 per tablet | $2.14 | -3% |
| Venlafaxine HCl 50 mg tablet | Generic | $0.0894 per tablet | $2.68 | -3% |
| Venlafaxine HCl 75 mg tablet | Generic | $0.0851 per tablet | $2.55 | no change |
| Venlafaxine HCl ER 150 mg capsule | Generic | $0.119 per capsule | $3.57 | -8% |
| Venlafaxine HCl ER 150 mg tablet | Generic | $0.228 per tablet | $6.83 | -5% |
| Venlafaxine HCl ER 225 mg tablet | Generic | $0.471 per tablet | $14.14 | -27% |
| Venlafaxine HCl ER 37.5 mg capsule | Generic | $0.0791 per capsule | $2.37 | -12% |
| Venlafaxine HCl ER 37.5 mg tablet | Generic | $0.358 per tablet | $10.74 | -42% |
| Venlafaxine HCl ER 75 mg capsule | Generic | $0.0799 per capsule | $2.40 | -13% |
| Venlafaxine HCl ER 75 mg tablet | Generic | $0.285 per tablet | $8.56 | -65% |
| Effexor XR 150 mg capsule | Brand | $21.62 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $648.66 | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has venlafaxine been recalled?
The FDA's Enforcement Report lists 27 recalls naming venlafaxine since 2012: 1 Class I (the most serious), 21 Class II, 5 Class III; 0 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of venlafaxine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 21, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet. |
| January 16, 2025 | Class III | Appco Pharma LLC | Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet |
| June 21, 2024 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals. |
| June 18, 2024 | Class II | The Harvard Drug Group LLC dba Major Pharmaceuticals and … | Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution. |
| July 29, 2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg |
| June 1, 2017 | Class II | Lucid Pharma LLC | Failed Tablet/Capsules Specifications: pharmacists complaints for bottles containing melted capsules. |
| December 22, 2016 | Class II | Aurobindo Pharma USA Inc | Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules. |
| August 3, 2016 | Class II | Golden State Medical Supply Inc. | Failed Dissolution Specifications: Out-of-specification results in retained sample. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the venlafaxine label say about other medicines?
The venlafaxine label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 18 other medicines name venlafaxine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alprazolam | drug interactions | This finding was confirmed in vivo by clinical drug interaction studies in which venlafaxine did not inhibit the metabolism of several CYP3A4 substrates, including alprazolam, diazepam, and terfenadine. |
| Amphetamine | drug interactions | … Laboratory Test Interference False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking venlafaxine due to lack of specificity of the screening tests. … |
| Aspirin | warnings and precautions | Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase risk ( 5.4 ). |
| Buspirone | drug interactions | Clinical Impact; Concomitant use of Effexor XR 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. |
| Caffeine | drug interactions | This finding was confirmed in vivo by a clinical drug interaction study in which venlafaxine did not inhibit the metabolism of caffeine, a CYP1A2 substrate. |
| Cimetidine | drug interactions | Concomitant administration of cimetidine and venlafaxine in a steady-state study for both drugs resulted in inhibition of first-pass metabolism of venlafaxine in 18 healthy subjects. |
| Desipramine | drug interactions | However, desipramine AUC, C max, and C min increased by about 35% in the presence of venlafaxine. |
| Desvenlafaxine | contraindications | CONTRAINDICATIONS Effexor XR is contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2) ]. |
| Dextromethorphan | drug interactions | These findings have been confirmed in a clinical drug interaction study comparing the effect of venlafaxine with that of fluoxetine on the CYP2D6-mediated metabolism of dextromethorphan to dextrorphan. |
| Diazepam | drug interactions | Venlafaxine also did not have any effect on the pharmacokinetics of diazepam or its active metabolite, desmethyldiazepam, or affect the psychomotor and psychometric effects induced by diazepam. |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. … |
| Fluoxetine | drug interactions | These findings have been confirmed in a clinical drug interaction study comparing the effect of venlafaxine with that of fluoxetine on the CYP2D6-mediated metabolism of dextromethorphan to dextrorphan. |
| Haloperidol | drug interactions | Increase in Haloperidol AUC and C max. ( 7.4 ) Ketoconazole: Increase in venlafaxine and O-desmethylvenlafaxine AUC and C max. |
| Imipramine | drug interactions | Imipramine - Venlafaxine did not affect the pharmacokinetics of imipramine and 2-OH-imipramine. |
Every other medicine the venlafaxine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Increase in Haloperidol AUC and C max. ( 7.4 ) Ketoconazole: Increase in venlafaxine and O-desmethylvenlafaxine AUC and C max. |
| Linezolid | contraindications | • 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 … |
| Lithium | drug interactions | … other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. |
| Meperidine | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone … |
| Methadone | warnings and precautions | … tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, and St. … |
| Methylene blue | contraindications | • 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 … |
| Metoprolol | drug interactions | Possibly reduced blood-pressure lowering effect despite increased metoprolol plasma levels. |
| Phentermine | drug interactions | … venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Effexor XR is not indicated for weight loss alone or in combination with other products. … |
| Quinidine | drug interactions | CYP2D6 inhibitors such as quinidine would be expected to do this, but the effect would be similar to what is seen in patients who are genetically CYP2D6 poor metabolizers [see Clinical Pharmacology … |
| Risperidone | drug interactions | Risperidone - Venlafaxine administered under steady-state conditions at 150 mg/day slightly inhibited the CYP2D6-mediated metabolism of risperidone (administered as a single 1 mg oral dose) to its … |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone … |
| Warfarin | warnings and precautions | Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase risk ( 5.4 ). |
Other labels that name venlafaxine
Source: FDA drug label (Effexor XR), NDA020699 (Upjohn), as published by Viatris Specialty LLC, effective August 15, 2023 (SPL set c848a5d8-ba94-4c84-80e3-0bf35fb8e32e), via openFDA; the full label on DailyMed
What do FAERS reports show for venlafaxine?
The FDA Adverse Event Reporting System holds 131,560 reports that list venlafaxine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 13,161 are coded as a death and 41,895 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as venlafaxine?
30 other medicines are given the same way (oral) and in the same FDA class as venlafaxine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Duloxetine | Depression, Anxiety | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Desvenlafaxine | Depression | 21 labelers | $0.396 per unit 50 mg | No current entry |
| Levomilnacipran | Depression | none listed | $17.61 per unit 20-40 mg titration pak | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
| Aripiprazole | Depression | 47 labelers | $0.110 per tablet 5 mg tablet | No current entry |
| Fluoxetine | Depression, Anxiety | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression, Anxiety | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as venlafaxine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does venlafaxine compare with medicines for the same use?
14 side-by-side pages set venlafaxine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to venlafaxine
- 30 medicines for the same use
- Other SNRIs
- the pharmacologic class, with prices and generics
- Venlafaxine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other