Recommended Topic Related To:

Klonopin

"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within "...

Klonopin

Klonopin Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Klonopin (Clonazepam) is a medication that belongs to the drug class benzodiazepine. Klonopin is available as a generic drug, and is prescribed for the treatment of anxiety and seizure disorders. Common side effects of Klonopin include sedation, dizziness, weakness, unsteadiness, depression, loss of orientation, headache, and sleep disturbances.

Klonopin dose depends on the condition being treated and how the patient responds. Drug interactions include alcohol, barbiturates, and narcotics. Klonopin use during pregnancy may cause adverse effects in the fetus and it is secreted in breast milk. If Klonopin is discontinued abruptly after long term use, it may lead to seizures, tremors, muscle cramping, vomiting, and/or sweating.

Our Klonopin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Klonopin in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, irritable, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

  • confusion, hallucinations, unusual thoughts or behavior;
  • weak or shallow breathing;
  • unusual risk-taking behavior, no fear of danger;
  • unusual or involuntary eye movements;
  • pounding heartbeats or fluttering in your chest;
  • painful or difficult urination, urinating less than usual;
  • pale skin, easy bruising or bleeding; or
  • new or worsening seizures.

Less serious side effects may include:

  • drowsiness, dizziness, problems with thinking or memory;
  • tired feeling, muscle weakness, loss of balance or coordination;
  • slurred speech, drooling or dry mouth, sore gums;
  • runny or stuffy nose;
  • loss of appetite, nausea, diarrhea, constipation;
  • blurred vision;
  • headache;
  • sleep problems (insomnia);
  • skin rash; or
  • weight changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Klonopin (Clonazepam) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Klonopin Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, tiredness, loss of coordination, or increased saliva production may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizures, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior, including: confusion, memory problems, signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor right away if any of these unlikely but serious side effects occur: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Klonopin (Clonazepam)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Klonopin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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, 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

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 Klonopin 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

Adverse Events Associated With Discontinuation of Treatment

Overall, the incidence of discontinuation due to adverse events was 17% in Klonopin 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 Klonopin than that of placebo included the following:

Table 2 : Most Common Adverse Events ( ≥ 1%) Associated with Discontinuation of Treatment

Adverse Event Klonopin
(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 Klonopin-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 Klonopin (doses ranging from 0.5 to 4 mg/day) and for which the incidence was greater than that in placebo-treated patients are included.

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*

Adverse Event by Body System < 1mg
n=96 %
1- < 2mg
n=129 %
2- < 3mg
n=113 %
> 3mg
n=235 %
All Klonopin 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 10 10 7 6 8 4
  Infection†
  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 Infectionf 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
* Events reported by at least 1% of patients treated with Klonopin and for which the incidence was greater than that for placebo.
† Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤ 0.10.
‡ Denominators for events in gender-specific systems are: n=240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female.

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 (Genentech Preferred Term) Clonazepam
(N=574)
Placebo
(N=294)
Somnolence 37% 10%
Depression 7% 1%
Coordination Abnormal 6% 0%
Ataxia 5% 0%
* Treatment-emergent events for which the incidence in the clonazepam patients was ≥ 5% and at least twice that in the placebo patients.

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 Klonopin-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 Klonopin-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 clonazepamtreated patients were not experiencing a worsening or emergence of clinical depression.

Other Adverse Events Observed During the Premarketing Evaluation of Klonopin in Panic Disorder

Following is a list of modified CIGY terms that reflect treatment-emergent adverse events reported by patients treated with Klonopin 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 Klonopin, 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

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

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

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

Drug Abuse And Dependence

Controlled Substance Class

Clonazepam is a Schedule IV controlled substance.

Physical and Psychological Dependence

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (eg, convulsions, psychosis, hallucinations, behavioral disorder, tremor, abdominal and muscle cramps) have occurred following abrupt discontinuance of clonazepam. The more severe withdrawal symptoms have usually been limited to those patients who received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed (see DOSAGE AND ADMINISTRATION). Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving clonazepam or other psychotropic agents because of the predisposition of such patients to habituation and dependence.

Following the short-term treatment of patients with panic disorder in Studies 1 and 2 (see: Clinical Trials), patients were gradually withdrawn during a 7-week downward-titration (discontinuance) period. Overall, the discontinuance period was associated with good tolerability and a very modest clinical deterioration, without evidence of a significant rebound phenomenon. However, there are not sufficient data from adequate and well-controlled long-term clonazepam studies in patients with panic disorder to accurately estimate the risks of withdrawal symptoms and dependence that may be associated with such use.

Read the entire FDA prescribing information for Klonopin (Clonazepam) »

A A A

Klonopin - User Reviews

Klonopin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Klonopin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Epilepsy

Find tips and treatments to control seizures.