This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: 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...
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. 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. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Klonopin was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the DSM-IIIR category of panic disorder (see CLINICAL PHARMACOLOGY: Clinical Trials ). Panic disorder (DSM-V) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abrup...
CONTRAINDICATIONS Klonopin is contraindicated in patients with the following conditions: History of sensitivity to benzodiazepines Clinical or biochemical evidence of significant liver disease Acute narrow angle glaucoma (it may be used in patients with open angle glaucoma who are receiving appropriate therapy).
WARNINGS Risks from Concomitant Use with Opioids Concomitant use of benzodiazepines, including Klonopin, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of benzodiazepines and opioids for patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe Klonopin concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Klonopin is used with opioids (see PRECAUTIONS: Information for Patients and PRECAUTIONS: Drug Interactions ). Abuse, Misuse, and Addiction The use of benzodiazepines, including KLONOPIN, exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but n...
ADVERSE REACTIONS The adverse experiences for Klonopin are provided separately for patients with seizure disorders and with panic disorder. Seizure Disorders The most frequently occurring side effects of Klonopin are referable to CNS depression. Experience in treatment of seizures has shown that drowsiness has occurred in approximately 50% of patients and ataxia in approximately 30%. In some cases, these may diminish with time; behavior problems have been noted in approximately 25% of patients. Others, listed by system, including those identified during postapproval use of Klonopin are: Cardiovascular: Palpitations Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums Genitourinary: Dysuria, enuresis, nocturia, urinary retention Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase Musculoskeletal: Muscle weakness, pains Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain Neurologic: A...
Source: FDA SPL label for Klonopin (H2-Pharma, LLC), effective 20251201. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 13,448 | 12,376 | 10,564 | 9,692 | 8,472 | 8,250 | 8,233 | 4,177 |
2,294 reports blaming this drug for every million Medicare prescriptions filled, which is 0.8× the typical drug on this site. (20,324 reports in 2024–2026, against 8,859,699 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 11/2024 | 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. |
| 11/2024 | 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. |
| 11/2024 | 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. |
| 11/2024 | 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. |
| 07/2024 | 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. The blister strips inside the product carton reflect the correct strength of 0.25 mg. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Clonazepam | 8,844,831 | $8 |
| Klonopin | 14,868 | $229 |
No same-class alternatives found in RxClass.