Prescription medicine
Clonazepam Brand names: Klonopin
Clonazepam (Klonopin) is a prescription medicine with an FDA approval on record since 1975. FDA's NDC Directory lists it from 31 generic labelers, and pharmacies paid $0.0244 per clonazepam 1 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- In shortage
- Boxed warning
- DEA Schedule IV
Check it at the source: the clonazepam FDA label on DailyMed (effective December 1, 2025, H2-Pharma, LLC); the NDA 17533 record on Drugs@FDA; every clonazepam label on DailyMed.
Highlights of the record
FDA label of December 1, 2025; 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 for 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 Klonopin, 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 Klonopin and throughout treatment, assess each patient's risk for abuse, misuse, and addiction (see WARNINGS ). The continued use of benzodiazepines, including Klonopin, 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 Klonopin after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageSeizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures.
Forms and strengths
- 0.125 mg
- 0.25 mg
- 0.5 mg
- 1 mg
- 2 mg
Tablet; orally disintegrating tablet.
On the market
- Earliest approval on file
- June 4, 1975 Klonopin, Cheplapharm; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 17 first September 10, 1996; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 32 of which 31 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0244 per tablet Clonazepam 1 mg tablet
- Shortage (FDA)
- 1 of 40 presentations limited or unavailable updated October 3, 2026
- Recalls by its makers (FDA)
- 7 since 2013 5 Class I among all firms' recalls; latest November 18, 2024; 3 more by firms not listed as its makers
- FAERS reports
- 159,283 through July 30, 2026
What is clonazepam used for?
From the label: indications and usageSeizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, Klonopin may be useful. Some loss of effect may occur during the course of clonazepam treatment (see PRECAUTIONS: Loss of Effect ). Panic Disorder Klonopin is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-V. […]
Conditions named in the indications of clonazepam's FDA labels, with every medicine labeled for each:
From other clonazepam labelsSeizures and epilepsy: INDICATIONS AND USAGE Seizure Disorders Klonopin is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures.
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Klonopin), NDA017533 (Cheplapharm), as published by H2-Pharma, LLC, effective December 1, 2025 (SPL set cfa0d79a-843c-4b88-95a1-e9511d649ca1), via openFDA; the full label on DailyMed
What does the patient leaflet for clonazepam 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 KLONOPIN?KLONOPIN 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 KLONOPIN and opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including KLONOPIN, 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 KLONOPIN. 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 KLONOPIN as prescribed by your healthcare provider. Take KLONOPIN exactly as your healthcare provider prescribed. Do not share your KLONOPIN with other people. Keep KLONOPIN in a safe place and away from children. Physical dependence and withdrawal reactions. KLONOPIN can cause physical dependence and withdrawal reactions. Do not suddenly stop taking KLONOPIN . […]
From the patient leaflet: What should I avoid while taking KLONOPIN?KLONOPIN can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how KLONOPIN affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking KLONOPIN until you talk to your healthcare provider. When taken with alcohol or medicines that cause sleepiness or dizziness, KLONOPIN may make your sleepiness or dizziness much worse.
From the patient leaflet: How should I store KLONOPIN?Store KLONOPIN between 59°F to 86°F (15°C to 30°C) Keep KLONOPIN and all medicines out of the reach of children General Information about the safe and effective use of KLONOPIN Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KLONOPIN for a condition for which it was not prescribed. Do not give KLONOPIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KLONOPIN that is written for health professionals.
Source: FDA drug label (Klonopin), NDA017533 (Cheplapharm), as published by H2-Pharma, LLC, effective December 1, 2025 (SPL set cfa0d79a-843c-4b88-95a1-e9511d649ca1), via openFDA; the full label on DailyMed
Is there a generic for clonazepam (Klonopin)?
The FDA approved the first generic clonazepam on September 10, 1996. 17 generic applications are approved; 12 of them carry 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 clonazepam from 31 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1975 earliest approval on file
- 1996 first generic approved
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clonazepam (Klonopin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0244 per Clonazepam 1 mg tablet, down 14% from $0.0285 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.
- Clonazepam 1 mg tablet (generic)
- Klonopin 0.5 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clonazepam 0.125 mg dis tablet | Generic | $0.520 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $15.60 | +3% |
| Clonazepam 0.125 mg ODT | Generic | $0.520 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
| Clonazepam 0.25 mg ODT | Generic | $0.438 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -0.7% |
| Clonazepam 0.5 mg dis tablet | Generic | $0.523 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $15.69 | -5% |
| Clonazepam 0.5 mg ODT | Generic | $0.523 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -5% |
| Clonazepam 0.5 mg tablet | Generic | $0.0196 per tablet | $0.588 | -10% |
| Clonazepam 1 mg dis tablet | Generic | $0.567 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $17.01 | +16% |
| Clonazepam 1 mg ODT | Generic | $0.567 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +16% |
| Clonazepam 1 mg tablet | Generic | $0.0244 per tablet | $0.731 | -14% |
| Clonazepam 2 mg ODT | Generic | $0.879 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | -4% |
| Clonazepam 2 mg tablet | Generic | $0.0402 per tablet | $1.21 | -6% |
| Klonopin 0.5 mg tablet | Brand | $2.68 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $80.37 | +10% |
| Klonopin 1 mg tablet | Brand | $3.05 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $91.61 | +10% |
| Klonopin 2 mg tablet | Brand | $4.25 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $127.41 | +10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Is clonazepam in shortage?
The FDA Drug Shortage Database lists 1 of 40 clonazepam presentations as limited or unavailable (updated October 3, 2026); the first entry was posted on March 10, 2023. 39 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Clonazepam, Tablet, .5 mg (NDC 0093-0832-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 0093-0832-05) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 16729-136-00) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 16729-136-16) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 43547-406-10) | Prinston Pharmaceutical, Inc. | Current | September 2, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 43547-406-11) | Prinston Pharmaceutical, Inc. | Current | September 2, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 43547-406-50) | Prinston Pharmaceutical, Inc. | Current | September 2, 2026 |
| Clonazepam, Tablet, .5 mg (NDC 59651-722-01) | Aurobindo Pharma USA | Current | October 2, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has clonazepam been recalled?
The FDA's Enforcement Report lists 10 recalls naming clonazepam since 2013: 5 Class I (the most serious), 2 Class II, 3 Class III; 4 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of clonazepam 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 |
|---|---|---|---|
| November 18, 2024 | Class I | Endo USA, Inc. | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength. |
| July 10, 2024 | Class I | Endo Pharmaceuticals, Inc. | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. … |
| September 28, 2016 | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) not a listed maker | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint. |
| September 28, 2016 | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) not a listed maker | Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint. |
| January 28, 2016 | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) | Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint. |
| November 6, 2013 | Class II | Actavis Elizabeth LLC | Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg) may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clonazepam label say about other medicines?
The clonazepam label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name clonazepam. 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 | Cytochrome P-450 inducers, such as phenytoin, carbamazepine, lamotrigine, and phenobarbital induce clonazepam metabolism, causing an approximately 38% decrease in plasma clonazepam levels. |
| Felbamate | drug interactions | The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam. |
| Fluconazole | drug interactions | Although clinical studies have not been performed, based on the involvement of the cytochrome P-450 3A family in clonazepam metabolism, inhibitors of this enzyme system, notably oral antifungal agents (e.g., fluconazole), should be used cautiously in patients receiving clonazepam because they may impair the metabolism … |
| Flumazenil | warnings | Abrupt discontinuation or rapid dosage reduction of KLONOPIN 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 | The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam. |
| Lamotrigine | drug interactions | Cytochrome P-450 inducers, such as phenytoin, carbamazepine, lamotrigine, and phenobarbital induce clonazepam metabolism, causing an approximately 38% decrease in plasma clonazepam levels. |
| Phenobarbital | drug interactions | Cytochrome P-450 inducers, such as phenytoin, carbamazepine, lamotrigine, and phenobarbital induce clonazepam metabolism, causing an approximately 38% decrease in plasma clonazepam levels. |
| Phenytoin | drug interactions | Clonazepam has the potential to influence concentrations of phenytoin. |
| Ranitidine | drug interactions | Effect of Other Drugs on the Pharmacokinetics of Clonazepam Literature reports suggest that ranitidine, an agent that decreases stomach acidity, does not greatly alter clonazepam pharmacokinetics. |
| Sertraline | drug interactions | The selective serotonin reuptake inhibitors sertraline (weak CYP3A4 inducer) and fluoxetine (CYP2D6 inhibitor), and the anti-epileptic drug felbamate (CYP2C19 inhibitor and CYP3A4 inducer) do not affect the pharmacokinetics of clonazepam. |
Other labels that name clonazepam
Source: FDA drug label (Klonopin), NDA017533 (Cheplapharm), as published by H2-Pharma, LLC, effective December 1, 2025 (SPL set cfa0d79a-843c-4b88-95a1-e9511d649ca1), via openFDA; the full label on DailyMed
What do FAERS reports show for clonazepam?
The FDA Adverse Event Reporting System holds 159,283 reports that list clonazepam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 18,605 are coded as a death and 47,308 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 clonazepam?
25 other medicines are given the same way (oral) and in the same FDA class as clonazepam or labeled mainly for the same use (seizures and epilepsy), the same class first. Seizures and epilepsy lists all 27 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 |
|---|---|---|---|---|
| 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 |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety, Seizures and epilepsy | 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 |
| Topiramate | Seizures and epilepsy | 47 labelers | $0.0567 per tablet 100 mg tablet | No current entry |
Every medicine labeled for the same conditions as clonazepam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does clonazepam compare with medicines for the same use?
21 side-by-side pages set clonazepam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to clonazepam
- 25 medicines for the same use
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Clonazepam side effects
- the label's list beside FAERS reports
- Clonazepam shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other