ADVERSE REACTIONS
The adverse experiences for clonazepam are provided separately for patients with seizure disorders and with panic disorder.
Seizure Disorders: The most frequently occurring side effects of clonazepam 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, are:
Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia, dysarthria, dysdiadochokinesis, 'glassy-eyed' appearance, headache, hemiparesis, hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo Buy Clonazepam Cas 1622-61-3
Psychiatric: Confusion, depression, amnesia, hallucinations, hysteria, increased libido, insomnia, psychosis (the behavior effects are more likely to occur in patients with a history of psychiatric disturbances). The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams
Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages
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
Musculoskeletal: Muscle weakness, pains
Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain
Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia
Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase
Panic Disorder: Adverse events during exposure to clonazepam were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, CIGY dictionary terminology has been used to classify reported adverse events, except in certain cases in which redundant terms were collapsed into more meaningful terms, as noted below.
The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials: Buy Clonazepam Cas 1622-61-3
Adverse Events Associated With Discontinuation of Treatment:
Overall, the incidence of discontinuation due to adverse events was 17% in clonazepam compared to 9% for placebo in the combined data of two 6- to 9-week trials. The most common events (≥1%) associated with discontinuation and a dropout rate twice or greater for clonazepam than that of placebo included the following:
Table 2. Most Common Adverse Events (≥1%) Associated with Discontinuation of Treatment
Adverse Event |
Clonazepam (N=574) |
Placebo (N=294) |
Somnolence |
7% |
1% |
Depression |
4% |
1% |
Dizziness |
1% |
<1% |
Nervousness |
1% |
0% |
Ataxia |
1% |
0% |
Intellectual Ability Reduced |
1% |
0% |
Adverse Events Occurring at an Incidence of 1% or More Among Clonazepam-Treated Patients:
Table 3 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of panic disorder from a pool of two 6- to 9-week trials. Events reported in 1% or more of patients treated with clonazepam (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included. Buy Clonazepam Cas 1622-61-3
The prescriber should be aware that the figures in Table 3 cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence in the population studied.
Table 3. Treatment-Emergent Adverse Event Incidence in 6- to 9-Week Placebo-Controlled Clinical Trials*
|
Clonazepam Maximum Daily Dose |
Adverse Event by Body System |
<1mg
n=96
% |
1-<2mg
n=129
% |
2-<3mg
n=113
% |
≥3mg
n=235
% |
All Clonazepam Groups
N=574
% |
Placebo
N=294
% |
Central & Peripheral Nervous System |
|
|
|
|
|
|
Somnolence† |
26 |
35 |
50 |
36 |
37 |
10 |
Dizziness |
5 |
5 |
12 |
8 |
8 |
4 |
Coordination Abnormal† |
1 |
2 |
7 |
9 |
6 |
0 |
Ataxia† |
2 |
1 |
8 |
8 |
5 |
0 |
Dysarthria† |
0 |
0 |
4 |
3 |
2 |
0 |
Psychiatric |
|
|
|
|
|
|
Depression |
7 |
6 |
8 |
8 |
7 |
1 |
Memory Disturbance |
2 |
5 |
2 |
5 |
4 |
2 |
Nervousness |
1 |
4 |
3 |
4 |
3 |
2 |
Intellectual Ability Reduced |
0 |
2 |
4 |
3 |
2 |
0 |
Emotional Lability |
0 |
1 |
2 |
2 |
1 |
1 |
Libido Decreased |
0 |
1 |
3 |
1 |
1 |
0 |
Confusion |
0 |
2 |
2 |
1 |
1 |
0 |
Respiratory System |
|
|
|
|
|
|
Upper Respiratory Tract Infection† |
10 |
10 |
7 |
6 |
8 |
4 |
Sinusitis |
4 |
2 |
8 |
4 |
4 |
3 |
Rhinitis |
3 |
2 |
4 |
2 |
2 |
1 |
Coughing |
2 |
2 |
4 |
0 |
2 |
0 |
Pharyngitis |
1 |
1 |
3 |
2 |
2 |
1 |
Bronchitis |
1 |
0 |
2 |
2 |
1 |
1 |
Gastrointestinal System |
|
|
|
|
|
|
Constipation† |
0 |
1 |
5 |
3 |
2 |
2 |
Appetite Decreased |
1 |
1 |
0 |
3 |
1 |
1 |
Abdominal Pain† |
2 |
2 |
2 |
0 |
1 |
1 |
Body as a Whole |
|
|
|
|
|
|
Fatigue |
9 |
6 |
7 |
7 |
7 |
4 |
Allergic Reaction |
3 |
1 |
4 |
2 |
2 |
1 |
Musculoskeletal |
|
|
|
|
|
|
Myalgia |
2 |
1 |
4 |
0 |
1 |
1 |
Resistance Mechanism Disorders |
|
|
|
|
|
|
Influenza |
3 |
2 |
5 |
5 |
4 |
3 |
Urinary System |
|
|
|
|
|
|
Micturition Frequency |
1 |
2 |
2 |
1 |
1 |
0 |
Urinary Tract Infection† |
0 |
0 |
2 |
2 |
1 |
0 |
Vision Disorders |
|
|
|
|
|
|
Blurred Vision |
1 |
2 |
3 |
0 |
1 |
1 |
Reproductive Disorders‡ |
|
|
|
|
|
|
Female |
|
|
|
|
|
|
Dysmenorrhea |
0 |
6 |
5 |
2 |
3 |
2 |
Colpitis |
4 |
0 |
2 |
1 |
1 |
1 |
Male |
|
|
|
|
|
|
Ejaculation Delayed |
0 |
0 |
2 |
2 |
1 |
0 |
Impotence |
3 |
0 |
2 |
1 |
1 |
0 |
Commonly Observed Adverse Events:
Table 4. Incidence of Most Commonly Observed Adverse Events*in Acute Therapy in Pool of 6- to 9-Week Trials
|
Adverse Event |
Clonazepam (N=574) |
Placebo (N=294) |
Somnolence |
37% |
10% |
Depression |
7% |
1% |
Coordination Abnormal |
6% |
0% |
Ataxia |
5% |
0% |
Treatment-Emergent Depressive Symptoms:
In the pool of two short-term placebo-controlled trials, adverse events classified under the preferred term 'depression' were reported in 7% of clonazepam-treated patients compared to 1% of placebo-treated patients, without any clear pattern of dose relatedness. In these same trials, adverse events classified under the preferred term 'depression' were reported as leading to discontinuation in 4% of clonazepam-treated patients compared to 1% of placebo-treated patients. While these findings are noteworthy, Hamilton Depression Rating Scale (HAM-D) data collected in these trials revealed a larger decline in HAM-D scores in the clonazepam group than the placebo group suggesting that clonazepam-treated patients were not experiencing a worsening or emergence of clinical depression. Buy Clonazepam Cas 1622-61-3
Other Adverse Events Observed During the Premarketing Evaluation of Clonazepam in Panic Disorder:
Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with clonazepam at multiple doses during clinical trials. All reported events are included except those already listed in Table 3 or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and events reported only once and which did not have a substantial probability of being acutely life-threatening. It is important to emphasize that, although the events occurred during treatment with clonazepam, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency. These adverse events were reported infrequently, which is defined as occurring in 1/100 to 1/1000 patients.
Body as a Whole: weight increase, accident, weight decrease, wound, edema, fever, shivering, abrasions, ankle edema, edema foot, edema periorbital, injury, malaise, pain, cellulitis, inflammation localized
Cardiovascular Disorders: chest pain, hypotension postural Buy Clonazepam Cas 1622-61-3
Central and Peripheral Nervous System Disorders: migraine, paresthesia, drunkenness, feeling of enuresis, paresis, tremor, burning skin, falling, head fullness, hoarseness, hyperactivity, hypoesthesia, tongue thick, twitching
Gastrointestinal System Disorders: abdominal discomfort, gastrointestinal inflammation, stomach upset, toothache, flatulence, pyrosis, saliva increased, tooth disorder, bowel movements frequent, pain pelvic, dyspepsia, hemorrhoids
Hearing and Vestibular Disorders: vertigo, otitis, earache, motion sickness
Heart Rate and Rhythm Disorders: palpitation
Metabolic and Nutritional Disorders: thirst, gout
Musculoskeletal System Disorders: back pain, fracture traumatic, sprains and strains, pain leg, pain nape, cramps muscle, cramps leg, pain ankle, pain shoulder, tendinitis, arthralgia, hypertonia, lumbago, pain feet, pain jaw, pain knee, swelling knee
Platelet, Bleeding and Clotting Disorders: bleeding dermal Buy Clonazepam Cas 1622-61-3
Psychiatric Disorders: insomnia, organic disinhibition, anxiety, depersonalization, dreaming excessive, libido loss, appetite increased, libido increased, reactions decreased, aggressive reaction, apathy, attention lack, excitement, feeling mad, hunger abnormal, illusion, nightmares, sleep disorder, suicide ideation, yawning
Reproductive Disorders, Female: breast pain, menstrual irregularity
Reproductive Disorders, Male: ejaculation decreased
Resistance Mechanism Disorders: infection mycotic, infection viral, infection streptococcal, herpes simplex infection, infectious mononucleosis, moniliasis
Respiratory System Disorders: sneezing excessive, asthmatic attack, dyspnea, nosebleed, pneumonia, pleurisy
Skin and Appendages Disorders: acne flare, alopecia, xeroderma, dermatitis contact, flushing, pruritus, pustular reaction, skin burns, skin disorder
Special Senses, Other Disorders: taste loss Buy Clonazepam Cas 1622-61-3
Urinary System Disorders: dysuria, cystitis, polyuria, urinary incontinence, bladder dysfunction, urinary retention, urinary tract bleeding, urine discoloration
Vascular (Extracardiac) Disorders: thrombophlebitis leg
Vision Disorders: eye irritation, visual disturbance, diplopia, eye twitching, styes, visual field defect, xerophthalmia Buy Clonazepam Cas 1622-61-3
MEDICATION GUIDE
Read this Medication Guide before you start taking clonazepam tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Clonazepam tablets can cause serious side effects. Because stopping clonazepam tablets suddenly can also cause serious problems, do not stop taking clonazepam tablets without talking to your healthcare provider first. Buy Clonazepam Cas 1622-61-3
What is the most important information I should know about clonazepam tablets?
Do not stop taking clonazepam tablets without first talking to your healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems.
Clonazepam tablets can cause serious side effects, including:
1. Clonazepam tablets can slow your thinking and motor skills
- Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse.
2. Like other antiepileptic drugs, clonazepam tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempt to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled. Buy Clonazepam Cas 1622-61-3
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
Do not stop clonazepam tablets without first talking to a healthcare provider.
Stopping clonazepam tablets suddenly can cause serious problems. Stopping clonazepam tablets suddenly can cause seizures that will not stop (status epilepticus).
3. Clonazepam tablets may harm your unborn or developing baby.
- If you take clonazepam tablets during pregnancy, your baby is at risk for serious birth defects. These defects can happen as early as in the first month of pregnancy, even before you know you are pregnant. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors.
- Children born to mothers receiving benzodiazepine medications (including clonazepam tablets) late in pregnancy may be at some risk of experiencing breathing problems, feeding problems, hypothermia, and withdrawal symptoms.
- Tell your healthcare provider right away if you become pregnant while taking clonazepam tablets. You and your healthcare provider should decide if you will take clonazepam tablets while you are pregnant.
- If you become pregnant while taking clonazepam tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Buy Clonazepam Cas 1622-61-3
- Clonazepam can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take clonazepam tablets. You and your healthcare provider should decide if you will take clonazepam tablets or breast feed. You should not do both.
4. Clonazepam tablets can cause abuse and dependence.
- Do not stop taking clonazepam tablets all of a sudden. Stopping clonazepam tablets suddenly can cause seizures that do not stop, hearing or seeing things that are not there (hallucinations), shaking, and stomach and muscle cramps.
- Talk to your doctor about slowly stopping clonazepam tablets to avoid getting sick with withdrawal symptoms.
- Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Clonazepam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep clonazepam tablets in a safe place to prevent misuse and abuse. Selling or giving away clonazepam tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. Buy Clonazepam Cas 1622-61-3
What are clonazepam tablets?
Clonazepam tablets are a prescription medicine used alone or with other medicines to treat:
- certain types of seizure disorders (epilepsy) in adults and children
- panic disorder with or without fear of open spaces (agoraphobia) in adults
It is not known if clonazepam tablets are safe or effective in treating panic disorder in children younger than 18 years old.
Who should not take clonazepam tablets?
Do not take clonazepam tablets if you:
- are allergic to benzodiazepines
- have significant liver disease
- have an eye disease called acute narrow angle glaucoma
Ask your healthcare provider if you are not sure if you have any of the problems listed above.
What should I tell my healthcare provider before taking clonazepam tablets?
Before you take clonazepam tablets, tell your healthcare provider if you:
- have liver or kidney problems
- have lung problems (respiratory disease)
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have any other medical conditions Buy Clonazepam Cas 1622-61-3
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Taking clonazepam tablets with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take clonazepam tablets?
- Take clonazepam tablets exactly as your healthcare provider tells you.
- Do not stop taking clonazepam tablets without first talking to your healthcare provider. Stopping clonazepam tablets suddenly can cause serious problems.
- Clonazepam tablets should be taken with water and swallowed whole.
- If you take too much clonazepam tablets, call your healthcare provider or local Poison Control Center right away.
What should I avoid while taking clonazepam tablets?
- Clonazepam tablets can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how clonazepam tablets affect you.
- Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking clonazepam tablets until you talk to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, clonazepam tablets may make your sleepiness or dizziness worse.
What are the possible side effects of clonazepam tablets?
See “What is the most important information I should know about clonazepam tablets?”
Clonazepam tablets can also make your seizures happen more often or make them worse. Call your healthcare provider right away if your seizures get worse while taking clonazepam tablets.
The most common side effects of clonazepam tablets include: Buy Clonazepam Cas 1622-61-3
- Drowsiness
- Problems with walking and coordination
- Dizziness
- Depression
- Fatigue
- Problems with memory
These are not all the possible side effects of clonazepam tablets. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store clonazepam tablets?
- Store clonazepam tablets at room temperature, between 68°F to 77°F (20°C to 25°C).
Keep clonazepam tablets and all medicines out of the reach of children.
General information about clonazepam tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clonazepam tablets for a condition for which it was not prescribed. Do not give clonazepam tablets 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 clonazepam tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about clonazepam tablets that is written for health professionals.
What are the ingredients in clonazepam tablets? Buy Clonazepam Cas 1622-61-3
Active ingredient: clonazepam
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and microcrystalline cellulose, with the following colorants: 0.5 mg – D&C Yellow #10 aluminum lake; 1 mg – FD&C Blue #1 aluminum lake.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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