Prescription medicine
Diazepam Brand names: Valium, Valtoco
Diazepam (Valium) is a prescription medicine with an FDA approval on record since 1963. FDA's NDC Directory lists it from 45 generic labelers, and pharmacies paid $0.0283 per diazepam 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the diazepam FDA label on DailyMed (effective August 11, 2026, Waylis Therapuetics LLC); the NDA 13263 record on Drugs@FDA; every diazepam label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION.
and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS ). The use of benzodiazepines, including VALIUM, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALIUM and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including VALIUM, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of VALIUM after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageValium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety.
Forms and strengths
- 2 mg
- 5 mg
- 10 mg
- 2.5 mg/.5ml
- 5 mg/ml
- 5 mg/5ml
- 5 mg/.1ml
- 7.5 mg/.1ml
- 10 mg/2ml
- 10 mg/.1ml
- 10 mg/2g
- 20 mg/4ml
Tablet; injection (solution); gel; solution; injection.
On the market
- Earliest approval on file
- November 15, 1963 Valium, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 64 first September 4, 1985; 28 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 50 of which 45 under generic applications, 4 under brand applications, repackagers included
- Last listed patent
- June 10, 2042 Valtoco spray; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0283 per tablet Diazepam 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 8 since 2012 0 Class I among all firms' recalls; latest February 9, 2022; 5 more by firms not listed as its makers
- FAERS reports
- 121,010 through July 30, 2026
What is diazepam used for?
From the label: indications and usageValium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Valium is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. […]
Conditions named in the indications of diazepam's FDA labels, with every medicine labeled for each:
From other diazepam labelsAnxiety: INDICATIONS Valium is indicated for the management of anxiety disorders or for the short- term relief of the symptoms of anxiety.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Valium), Waylis Therapuetics LLC, effective August 11, 2026 (SPL set 260e2041-2bb3-482f-850e-b5d47a7bdbe6), via openFDA; the full label on DailyMed
What does the patient leaflet for diazepam 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 VALIUM?VALIUM is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. Get emergency help right away if any of the following happens: Shallow or slowed breathing, Breathing stops (which may lead to the heart stopping), Excessive sleepiness (sedation). Do not drive or operate heavy machinery until you know how taking VALIUM with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including VALIUM, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including VALIUM. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take VALIUM exactly as prescribed by your healthcare provider. Take VALIUM exactly as your healthcare provider prescribed. Do not share your VALIUM with other people. Keep VALIUM in a safe place and away from children. Physical dependence and withdrawal reactions. VALIUM can cause physical dependence and withdrawal reactions. Do not suddenly stop taking VALIUM. […]
From the patient leaflet: How should I store VALIUM?Store VALIUM in a tightly closed container at room temperature between 68°F to 77°F (20°C to 25°C) and out of the light. Keep VALIUM and all medicines out of the reach of children.
Source: FDA drug label (Valium), Waylis Therapuetics LLC, effective August 11, 2026 (SPL set 260e2041-2bb3-482f-850e-b5d47a7bdbe6), via openFDA; the full label on DailyMed
Is there a generic for diazepam (Valium)?
The FDA approved the first generic diazepam on September 4, 1985. 64 generic applications are approved; 28 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 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists diazepam from 45 labelers under a generic (ANDA) application and from 4 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 Valium tablets; a patent listed only for Valtoco spray runs to June 10, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1963 earliest approval on file
- 1985 first generic approved
- 2042 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 diazepam (Valium)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0283 per Diazepam 10 mg tablet, down 5% from $0.0298 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.
- Diazepam 5 mg tablet (generic)
- Valtoco 10 mg nasal spray (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Diazepam 10 mg rectal gel (2pk) | Generic | $208.71 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -20% |
| Diazepam 10 mg rectal gel syrg | Generic | $208.71 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -20% |
| Diazepam 10 mg tablet | Generic | $0.0283 per tablet | $0.848 | -5% |
| Diazepam 2 mg tablet | Generic | $0.0212 per tablet | $0.637 | -4% |
| Diazepam 20 mg rectal gel (2pk) | Generic | $171.54 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -28% |
| Diazepam 25 mg/5 mL oral conc | Generic | $1.06 per mL | n/a | +3% |
| Diazepam 5 mg tablet | Generic | $0.0276 per tablet | $0.828 | -10% |
| Diazepam 5 mg/5 mL solution | Generic | $0.107 per mL | n/a | -1% |
| Diazepam 5 mg/mL oral conc | Generic | $1.06 per mL | n/a | +3% |
| Valtoco 10 mg nasal spray | Brand | $365.47 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +4% |
| Valtoco 15 mg nasal spray | Brand | $365.51 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +4% |
| Valtoco 20 mg nasal spray | Brand | $365.64 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +4% |
| Valtoco 5 mg nasal spray | Brand | $366.14 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has diazepam been recalled?
The FDA's Enforcement Report lists 13 recalls naming diazepam since 2012: 0 Class I (the most serious), 12 Class II, 1 Class III; 0 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of diazepam 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 |
|---|---|---|---|
| February 9, 2022 | Class II | Lannett Company, Inc. | Failed Impurities/Degradation Specifications: Out of specification results for related substances. |
| June 19, 2019 | Class II | RXQ Compounding LLC not a listed maker | Lack of Assurance of Sterility |
| July 10, 2018 | Class III | Valeant Pharmaceuticals North America LLC | Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton. |
| June 23, 2016 | Class II | Hospira Inc. | Crystallization: Product contains particulate identified to be crystallized active ingredient. |
| August 27, 2014 | Class II | Martin Avenue Pharmacy, Inc. not a listed maker | Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. … |
| August 16, 2013 | Class II | Hospira Inc. | Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. |
| May 16, 2013 | Class II | Hospira Inc. | Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. |
| March 25, 2013 | Class II | Pallimed Solutions not a listed maker | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diazepam label say about other medicines?
The diazepam label names 20 other medicines in its interaction, contraindication or warning sections. The labels of 50 other medicines name diazepam. 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 |
|---|---|---|
| Carbamazepine | drug interactions | Inducers of CYP2C19 and CYP3A4 Inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone, and phenobarbital) could increase the rate of diazepam elimination; therefore, efficacy of VALTOCO may be decreased. |
| Cimetidine | drug interactions | At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. |
| Clotrimazole | drug interactions | Inhibitors of CYP2C19 and CYP3A4 Inhibitors of CYP2C19 (e.g., cimetidine, quinidine, and tranylcypromine) and CYP3A4 (e.g., ketoconazole, troleandomycin, and clotrimazole) could decrease the rate of diazepam elimination; therefore, adverse reactions to VALTOCO may be increased. |
| Cyclosporine | drug interactions | Metabolism of Other Drugs Diazepam is a substrate for CYP2C19 and CYP3A4; therefore, it is possible that VALTOCO may interfere with the metabolism of drugs which are substrates for CYP2C19 (e.g., omeprazole, propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to … |
| Dexamethasone | drug interactions | Inducers of CYP2C19 and CYP3A4 Inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone, and phenobarbital) could increase the rate of diazepam elimination; therefore, efficacy of VALTOCO may be decreased. |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of Valium after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) (see DRUG ABUSE AND DEPENDENCE: |
| Fluoxetine | drug interactions | At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. |
| Fluvoxamine | drug interactions | At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. |
| Imipramine | drug interactions | Metabolism of Other Drugs Diazepam is a substrate for CYP2C19 and CYP3A4; therefore, it is possible that VALTOCO may interfere with the metabolism of drugs which are substrates for CYP2C19 (e.g., omeprazole, propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to … |
| Ketoconazole | drug interactions | At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. |
| Omeprazole | drug interactions | At present, this reaction is known to occur with cimetidine, ketoconazole, fluvoxamine, fluoxetine, and omeprazole. |
| Paclitaxel | drug interactions | Metabolism of Other Drugs Diazepam is a substrate for CYP2C19 and CYP3A4; therefore, it is possible that VALTOCO may interfere with the metabolism of drugs which are substrates for CYP2C19 (e.g., omeprazole, propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to … |
| Phenobarbital | drug interactions | Inducers of CYP2C19 and CYP3A4 Inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone, and phenobarbital) could increase the rate of diazepam elimination; therefore, efficacy of VALTOCO may be decreased. |
| Phenytoin | drug interactions | Phenytoin There have also been reports that the metabolic elimination of phenytoin is decreased by diazepam. |
Every other medicine the diazepam label names
| Medicine named | Section | What the label says |
|---|---|---|
| Propranolol | drug interactions | … metabolism of drugs which are substrates for CYP2C19 (e.g., omeprazole, propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to a potential … |
| Quinidine | drug interactions | Inhibitors of CYP2C19 and CYP3A4 Inhibitors of CYP2C19 (e.g., cimetidine, quinidine, and tranylcypromine) and CYP3A4 (e.g., ketoconazole, troleandomycin, and clotrimazole) could decrease the rate of … |
| Rifampin | drug interactions | Inducers of CYP2C19 and CYP3A4 Inducers of CYP2C19 (e.g., rifampin) and CYP3A4 (e.g., carbamazepine, phenytoin, dexamethasone, and phenobarbital) could increase the rate of diazepam elimination; … |
| Theophylline | drug interactions | … propranolol, and imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to a potential drug-drug interaction. |
| Tranylcypromine | drug interactions | Inhibitors of CYP2C19 and CYP3A4 Inhibitors of CYP2C19 (e.g., cimetidine, quinidine, and tranylcypromine) and CYP3A4 (e.g., ketoconazole, troleandomycin, and clotrimazole) could decrease the rate of … |
| Warfarin | drug interactions | … imipramine) and CYP3A4 (e.g., cyclosporine, paclitaxel, theophylline, and warfarin) leading to a potential drug-drug interaction. |
Other labels that name diazepam
- Aminophylline
- Armodafinil
- Buspirone
- Chlordiazepoxide and clidinium
- Clonazepam
- Clorazepate
- Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide
- Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil
- Darunavir
- Divalproex
- Esomeprazole
- Etravirine
- Fentanyl
- Fosamprenavir
- Itraconazole
- Mirtazapine
- Modafinil
- Olanzapine
- Raloxifene
- Ritonavir
- Stiripentol
- Sufentanil
- Valproic acid
- Venlafaxine
Source: FDA drug label (Valium), Waylis Therapuetics LLC, effective August 11, 2026 (SPL set 260e2041-2bb3-482f-850e-b5d47a7bdbe6), via openFDA; the full label on DailyMed
What do FAERS reports show for diazepam?
The FDA Adverse Event Reporting System holds 121,010 reports that list diazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22,964 are coded as a death and 42,069 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 diazepam?
11 other medicines are given the same way (oral) and in the same FDA class as diazepam or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 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 |
|---|---|---|---|---|
| Clonazepam | Anxiety | 31 labelers | $0.0244 per tablet 1 mg tablet | In shortage |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Amitriptyline and chlordiazepoxide | Anxiety | 1 labeler | $1.20 per unit 5-12.5 | No current entry |
| Buspirone | Anxiety | 49 labelers | $0.043 per tablet 15 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does diazepam compare with medicines for the same use?
16 side-by-side pages set diazepam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to diazepam
- 11 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Diazepam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other