Prescription medicine
Nefazodone First approved as Serzone
Nefazodone (Serzone) is a prescription medicine with an FDA approval on record since 1994. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $1.17 per nefazodone HCl 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the nefazodone FDA label on DailyMed (effective July 31, 2025, Teva Pharmaceuticals USA, Inc.); the NDA 20152 record on Drugs@FDA; every nefazodone label on DailyMed.
Highlights of the record
FDA label of July 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nefazodone hydrochloride tablets 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. Nefazodone hydrochloride tablets are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use ). […]
Used for
From the label: indications and usageNefazodone hydrochloride tablets are indicated for the treatment of depression.
Forms and strengths
- 50 mg
- 100 mg
- 150 mg
- 200 mg
- 250 mg
Tablet.
On the market
- Earliest approval on file
- December 22, 1994 Serzone, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first September 16, 2003; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $1.17 per tablet Nefazodone HCl 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2013 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 121 through July 30, 2026
What is nefazodone used for?
From the label: indications and usageNefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see WARNINGS ). In many cases, this would lead to the conclusion that other drugs should be tried first. The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY ). […]
Conditions named in the indications of nefazodone's FDA labels, with every medicine labeled for each:
From other nefazodone labelsDepression: INDICATIONS AND USAGE Nefazodone hydrochloride tablets are indicated for the treatment of depression.
FDA pharmacologic class: Serotonin Reuptake Inhibitor.
Source: FDA drug label (Nefazodone Hydrochloride), Teva Pharmaceuticals USA, Inc., effective July 31, 2025 (SPL set 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f), via openFDA; the full label on DailyMed
Is there a generic for nefazodone (Serzone)?
The FDA approved the first generic nefazodone on September 16, 2003. 7 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists nefazodone from 2 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1994 earliest approval on file
- 2003 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nefazodone (Serzone)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.17 per Nefazodone HCl 100 mg tablet, down 9% from $1.28 on October 8, 2025. 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.
- Nefazodone HCl 100 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nefazodone HCl 100 mg tablet | Generic | $1.17 per tablet | $34.97 | -9% |
| Nefazodone HCl 200 mg tablet | Generic | $1.33 per tablet | $39.92 | -6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has nefazodone been recalled?
The FDA's Enforcement Report lists 2 recalls naming nefazodone since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of nefazodone 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 |
|---|---|---|---|
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 200 mg may have potentially been mislabeled as the following drug: NEFAZODONE HCL, Tablet, 150 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: NEFAZODONE HCL, Tablet, 150 mg may have potentially been mislabeled as the following drug: LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nefazodone label say about other medicines?
The nefazodone label names 26 other medicines in its interaction, contraindication or warning sections. The labels of 35 other medicines name nefazodone. 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 | Triazolam/Alprazolam – See CONTRAINDICATIONS and WARNINGS . |
| Atorvastatin | drug interactions | HMG-CoA Reductase Inhibitors – When single 40 mg doses of simvastatin or atorvastatin, both substrates of CYP3A4, were given to healthy adult volunteers who had received nefazodone hydrochloride, 200 mg BID for 6 days, approximately 20 fold increases in plasma concentrations of simvastatin and simvastatin acid and 3 … |
| Buspirone | drug interactions | Buspirone – In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg BID) with nefazodone (250 mg BID) resulted in marked increases in plasma buspirone concentrations (increases up to 20 fold in C max and up to 50 fold in AUC) and statistically significant decreases … |
| Carbamazepine | contraindications | CONTRAINDICATIONS Coadministration of terfenadine, astemizole, cisapride, pimozide, or carbamazepine with nefazodone hydrochloride is contraindicated (see WARNINGS and PRECAUTIONS ). |
| Cimetidine | drug interactions | Cimetidine When nefazodone (200 mg BID) and cimetidine (300 mg QID) were coadministered for one week, no change in the steady-state pharmacokinetics of either nefazodone or cimetidine was observed compared to each dosed alone. |
| Cyclosporine | drug interactions | Immunosuppressive Agents There have been reports of increased blood concentrations of cyclosporine and tacrolimus into toxic ranges when patients received these drugs concomitantly with nefazodone. |
| Desipramine | drug interactions | Desipramine – When nefazodone (150 mg BID) and desipramine (75 mg QD) were administered together there were no changes in the pharmacokinetics of desipramine or its metabolite, 2-hydroxy desipramine. |
| Dextromethorphan | drug interactions | Such individuals are referred to commonly as “poor metabolizers” of drugs such as debrisoquin, dextromethorphan, and the tricyclic antidepressants. |
| Digoxin | drug interactions | Cardiovascular-Active Drugs Digoxin – When nefazodone (200 mg BID) and digoxin (0.2 mg QD) were coadministered for 9 days to healthy male volunteers (n = 18) who were phenotyped as CYP2D6 extensive metabolizers, C max, C min, and AUC of digoxin were increased by 29%, 27%, and 15%, respectively. |
| Erythromycin | warnings | Potential Terfenadine, Astemizole, Cisapride, and Pimozide Interactions Terfenadine, astemizole, cisapride, and pimozide are all metabolized by the cytochrome P450 3A4 (CYP3A4) isozyme, and it has been demonstrated that ketoconazole, erythromycin, and other inhibitors of CYP3A4 can block the metabolism of these drugs … |
| Fluoxetine | drug interactions | When a 200 mg dose of nefazodone was administered to subjects who had been receiving fluoxetine for 1 week, there was an increased incidence of transient adverse events such as headache, lightheadedness, nausea, or paresthesia, possibly due to the elevated mCPP levels. |
| Fluvastatin | drug interactions | Since metabolic interactions are unlikely between nefazodone and HMG-CoA reductase inhibitors that undergo little or no metabolism by the CYP3A4 isozyme, such as pravastatin or fluvastatin, dosage adjustments should not be necessary. |
| Haloperidol | drug interactions | Haloperidol – When a single oral 5 mg dose of haloperidol was coadministered with nefazodone (200 mg BID) at steady state, haloperidol apparent clearance decreased by 35% with no significant increase in peak haloperidol plasma concentrations or time of peak. |
| Ketoconazole | warnings | Potential Terfenadine, Astemizole, Cisapride, and Pimozide Interactions Terfenadine, astemizole, cisapride, and pimozide are all metabolized by the cytochrome P450 3A4 (CYP3A4) isozyme, and it has been demonstrated that ketoconazole, erythromycin, and other inhibitors of CYP3A4 can block the metabolism of these drugs … |
Every other medicine the nefazodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | drug interactions | When the two drugs were coadministered, there were no changes in the steady-state pharmacokinetics of either lithium, nefazodone, or its metabolite HO-NEF; … |
| Lorazepam | drug interactions | Lorazepam – When lorazepam (2 mg BID) and nefazodone (200 mg BID) were coadministered to steady state, there was no change in any pharmacokinetic parameter for either drug compared to each drug … |
| Lovastatin | drug interactions | … are metabolized by CYP3A4, such as simvastatin, atorvastatin, and lovastatin, and dosage adjustments of these HMG-CoA reductase inhibitors are recommended. |
| Phenytoin | drug interactions | However, due to the nonlinear pharmacokinetics of phenytoin, the failure to observe a significant effect on the single-dose pharmacokinetics of phenytoin does not preclude the possibility of a … |
| Pimozide | contraindications | CONTRAINDICATIONS Coadministration of terfenadine, astemizole, cisapride, pimozide, or carbamazepine with nefazodone hydrochloride is contraindicated (see WARNINGS and PRECAUTIONS ). |
| Pravastatin | drug interactions | … nefazodone had no significant effect on the plasma concentrations of pravastatin, which is not metabolized by CYP3A4 to a clinically significant extent. |
| Propranolol | drug interactions | Propranolol – The coadministration of nefazodone (200 mg BID) and propranolol (40 mg BID) for 5.5 days to healthy male volunteers (n = 18), including 3 poor and 15 extensive CYP2D6 metabolizers … |
| Simvastatin | drug interactions | HMG-CoA Reductase Inhibitors – When single 40 mg doses of simvastatin or atorvastatin, both substrates of CYP3A4, were given to healthy adult volunteers who had received nefazodone hydrochloride, 200 … |
| Tacrolimus | drug interactions | Immunosuppressive Agents There have been reports of increased blood concentrations of cyclosporine and tacrolimus into toxic ranges when patients received these drugs concomitantly with nefazodone. |
| Theophylline | drug interactions | Theophylline When nefazodone (200 mg BID) was given to patients being treated with theophylline (600 to 1200 mg/day) for chronic obstructive pulmonary disease, there was no change in the steady-state … |
| Triazolam | contraindications | The coadministration of triazolam and nefazodone causes a significant increase in the plasma level of triazolam (see WARNINGS and PRECAUTIONS ), and a 75% reduction in the initial triazolam dosage is … |
| Warfarin | drug interactions | Warfarin – There were no effects on the prothrombin or bleeding times or upon the pharmacokinetics of R-warfarin when nefazodone (200 mg BID) was administered for 1 week to subjects who had been … |
Other labels that name nefazodone
- Avanafil
- Budesonide
- Cabazitaxel
- Cabozantinib
- Calcifediol
- Colchicine
- Dihydroergotamine
- Doxazosin
- Dronedarone
- Erlotinib
- Fluticasone
- Irinotecan
- Mifepristone
- Mometasone
- Nifedipine
- Nimodipine
- Paclitaxel
- Palbociclib
- Paricalcitol
- Quetiapine
- Ranolazine
- Ritonavir
- Salmeterol
- Saxagliptin
- Suvorexant
- Temsirolimus
- Ticagrelor
- Toremifene
- Trabectedin
- Tranylcypromine
- Trastuzumab emtansine
- Umeclidinium and vilanterol
Source: FDA drug label (Nefazodone Hydrochloride), Teva Pharmaceuticals USA, Inc., effective July 31, 2025 (SPL set 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f), via openFDA; the full label on DailyMed
What do FAERS reports show for nefazodone?
The FDA Adverse Event Reporting System holds 121 reports that list nefazodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4 are coded as a death and 21 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.
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 nefazodone?
30 other medicines are given the same way (oral) and in the same FDA class as nefazodone 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 |
|---|---|---|---|---|
| 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 |
| Paroxetine | Depression | 45 labelers | $0.0611 per tablet 20 mg tablet | No current entry |
| Trazodone | Depression | 38 labelers | $0.0307 per tablet 50 mg tablet | No current entry |
| Escitalopram | Depression | 44 labelers | $0.0632 per tablet 20 mg tablet | No current entry |
| Citalopram | Depression | 35 labelers | $0.026 per tablet 10 mg tablet | No current entry |
| Fluoxetine and olanzapine | Depression | 3 labelers | $3.44 per unit 3-25 mg | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Every medicine labeled for the same conditions as nefazodone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nefazodone
- 30 medicines for the same use
- Other serotonin reuptake inhibitors
- the pharmacologic class, with prices and generics
- Nefazodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other