Prescription medicine
Desvenlafaxine Brand names: Pristiq
Desvenlafaxine (Pristiq) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $0.396 per unit (Desvenlafaxine succnt ER 50 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the desvenlafaxine FDA label on DailyMed (effective January 27, 2023, Alembic Pharmaceuticals Limited); the NDA 21992 record on Drugs@FDA; every desvenlafaxine label on DailyMed.
Highlights of the record
FDA label of January 27, 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 children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. Desvenlafaxine 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 thinking and behavior in children, adolescents and young adults taking antidepressants (5.1). Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1) Desvenlafaxine is not approved for use in pediatric patients (8.4).
Used for
From the label: indications and usageDesvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)].
Forms and strengths
- 25 mg
- 50 mg
- 100 mg
Extended-release tablet; film-coated extended-release tablet.
On the market
- Earliest approval on file
- February 29, 2008 Pristiq, Pf Prism Cv; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first June 29, 2015; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 20 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- July 5, 2027 Pristiq tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.396 per unit Desvenlafaxine succnt ER 50 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2014 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 26,842 through July 30, 2026
What is desvenlafaxine used for?
From the label: indications and usageDesvenlafaxine, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) [see Clinical Studies (14) and Dosage and Administration (2.1)]. The efficacy of desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) of outpatients who met DSM-IV criteria for major depressive disorder. Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder (MDD) (1).
Conditions named in the indications of desvenlafaxine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (Desvenlafaxine), Alembic Pharmaceuticals Limited, effective January 27, 2023 (SPL set 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8), via openFDA; the full label on DailyMed
What does the patient leaflet for desvenlafaxine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking desvenlafaxine?Do not drive a car or operate machinery until you know how desvenlafaxine affects you. • Avoid drinking alcohol while taking desvenlafaxine.
From the patient leaflet: How should I store desvenlafaxine?Store desvenlafaxine at room temperature between 68°F to 77°F (20°C to 25°C). • Do not use desvenlafaxine after the expiration date (EXP), which is on the container. The expiration date refers to the last day of that month. • Keep desvenlafaxine and all medicines out of the reach of children. General Information about the safe and effective use of desvenlafaxine Medicines are sometimes used for conditions that are not mentioned in Medication Guides. Do not use desvenlafaxine for a condition for which it was not prescribed. Do not give desvenlafaxine to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about desvenlafaxine. If you would like more information, talk with your healthcare provider. […]
Source: FDA drug label (Desvenlafaxine), Alembic Pharmaceuticals Limited, effective January 27, 2023 (SPL set 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8), via openFDA; the full label on DailyMed
Is there a generic for desvenlafaxine (Pristiq)?
The FDA approved the first generic desvenlafaxine on June 29, 2015. 11 generic applications are approved; 10 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 desvenlafaxine from 20 labelers under a generic (ANDA) application and from 3 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 1 patent for Pristiq tablets: the compound patent runs to July 5, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2015 first generic approved
- 2027 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 desvenlafaxine (Pristiq)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.396 per unit (Desvenlafaxine succnt ER 50 mg), down 6% from $0.423 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.
- Desvenlafaxine succnt ER 50 mg (generic)
- Pristiq ER 100 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Desvenlafaxine ER 100 mg tablet | Generic | $3.81 per tablet | $114.42 | +0.7% |
| Desvenlafaxine ER 50 mg tablet | Generic | $3.76 per tablet | $112.66 | -0.7% |
| Desvenlafaxine succnt ER 100 mg | Generic | $0.414 per unit | n/a | -6% |
| Desvenlafaxine succnt ER 25 mg | Generic | $0.399 per unit | n/a | -12% |
| Desvenlafaxine succnt ER 50 mg | Generic | $0.396 per unit | n/a | -6% |
| Pristiq ER 100 mg tablet | Brand | $13.93 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $418.02 | -0.2% |
| Pristiq ER 25 mg tablet | Brand | $13.97 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $419.19 | -0.2% |
| Pristiq ER 50 mg tablet | Brand | $13.96 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $418.90 | no change |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has desvenlafaxine been recalled?
The FDA's Enforcement Report lists 2 recalls naming desvenlafaxine since 2014: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| April 16, 2014 | Class II | Pfizer Us Pharmaceutical Group | Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the desvenlafaxine label say about other medicines?
The desvenlafaxine label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name desvenlafaxine. 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 |
|---|---|---|
| Amphetamine | drug interactions | Drug-Laboratory Test Interactions False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking desvenlafaxine. |
| Aripiprazole | drug interactions | Clinical studies have shown that desvenlafaxine (100 mg daily) does not have a clinically relevant effect on tamoxifen and aripiprazole, compounds that are metabolized by a combination of both CYP2D6 and CYP3A4 enzymes (Figure 2). |
| Aspirin | drug interactions | These studies have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. |
| Atomoxetine | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with desvenlafaxine 100 mg or lower or when desvenlafaxine is discontinued. |
| Buspirone | warnings and precautions | … serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue desvenlafaxine and initiate supportive treatment. |
| Desipramine | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with desvenlafaxine 100 mg or lower or when desvenlafaxine is discontinued. |
| Dextromethorphan | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when co-administered with desvenlafaxine 100 mg or lower or when desvenlafaxine is discontinued. |
| Fentanyl | warnings and precautions | … especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue desvenlafaxine and initiate supportive treatment. |
| Isocarboxazid | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Linezolid | contraindications | Starting desvenlafaxine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.6) and Warnings and Precautions (5.2)]. |
| Lithium | warnings and precautions | … when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). If such symptoms occur, discontinue desvenlafaxine and initiate supportive treatment. |
| 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, amphetamines, and St. … |
| Methadone | 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. … |
| Methylene blue | contraindications | Starting desvenlafaxine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.6) and Warnings and Precautions (5.2)]. |
Every other medicine the desvenlafaxine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Metoprolol | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when … |
| Midazolam | drug interactions | Interactions with PRISTIQ Based on pharmacokinetic studies, no dosage adjustment is required for drugs that are mainly metabolized by CYP3A4 (e.g., midazolam), or for drugs that are metabolized by … |
| Nebivolol | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when … |
| Perphenazine | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when … |
| Phenelzine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Selegiline | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Tamoxifen | drug interactions | Clinical studies have shown that desvenlafaxine (100 mg daily) does not have a clinically relevant effect on tamoxifen and aripiprazole, compounds that are metabolized by a combination of both CYP2D6 … |
| Tolterodine | drug interactions | Substrates primarily metabolized by CYP2D6 (e.g., desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, tolterodine) should be dosed at the original level when … |
| Tramadol | warnings and precautions | … (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort). … |
| Tranylcypromine | drug interactions | Examples; selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue |
| Venlafaxine | contraindications | CONTRAINDICATIONS Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine extended-release tablets formulation. |
| Warfarin | drug interactions | Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are co-administered with warfarin. |
Source: FDA drug label (Desvenlafaxine), Alembic Pharmaceuticals Limited, effective January 27, 2023 (SPL set 9f74708c-6f6a-46cf-8c79-87a25c2bb6f8), via openFDA; the full label on DailyMed
What do FAERS reports show for desvenlafaxine?
The FDA Adverse Event Reporting System holds 26,842 reports that list desvenlafaxine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 841 are coded as a death and 3,589 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 desvenlafaxine?
30 other medicines are given the same way (oral) and in the same FDA class as desvenlafaxine 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 |
|---|---|---|---|---|
| Venlafaxine | Depression | 62 labelers | $0.0799 per capsule 75 mg capsule | No current entry |
| Duloxetine | Depression | 45 labelers | $0.102 per capsule 30 mg capsule | 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 | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 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 desvenlafaxine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does desvenlafaxine compare with medicines for the same use?
8 side-by-side pages set desvenlafaxine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to desvenlafaxine
- 30 medicines for the same use
- Other SNRIs
- the pharmacologic class, with prices and generics
- Desvenlafaxine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other