What is Prescribing information?
Reproductive Disorders, Male: ejaculation decreased.
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.
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.
Genitourinary: Dysuria, enuresis, nocturia, urinary retention.
Klonopin is available as a generic drug, and is prescribed for the treatment of anxiety and seizure disorders. Common side effects of Klonopin include drowsiness, dizziness, weakness, unsteadiness, depression, loss of orientation, headache, sleep disturbances, problems with thinking or memory, slurred speech, dry mouth, sore gums, runny nose, loss of appetite, diarrhea, constipation, and blurred vision. Klonopin (Clonazepam) is a medication that belongs to the drug class benzodiazepine.
Respiratory System Disorders: sneezing excessive, asthmatic attack, dyspnea, nosebleed, pneumonia, pleurisy.
Heart Rate and Rhythm Disorders: palpitation.
Hematopoietic: Anemia, leukopenia, thrombocytopenia, eosinophilia.
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.
Metabolic and Nutritional Disorders: thirst, gout.
Cardiovascular Disorders: chest pain, hypotension postural.
Visit the FDA MedWatch website or call 1-800-FDA-1088. You are encouraged to report negative side effects of prescription drugs to the FDA.
What is Patient Information Overview?
Reproductive Disorders, Female: breast pain, menstrual irregularity.
Resistance Mechanism Disorders: infection mycotic, infection viral, infection streptococcal, herpes simplex infection, infectious mononucleosis, moniliasis.
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.
Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed (see DOSAGE AND ADMINISTRATION ). 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. 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. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain".
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. 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. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators.
Plaet, Bleeding and Clotting Disorders: bleeding dermal.
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% Inlectual Ability Reduced 1% 0%
FDA Approves Aptiom to Treat Seizures in Adults »
Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy. "The U.S.
Special Senses Other, Disorders: taste loss.
Our Klonopin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Gastrointestinal: Anorexia, coated tongue, constipation, diarrhea, dry mouth, encopresis, gastritis, increased appetite, nausea, sore gums.
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. Adverse events during exposure to Klonopin were obtained by spontaneous report and recorded by clinical investigators using terminology of their own choosing. 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.
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.
Call your doctor at once if you have a serious side effect such as:
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Report Problems to the Food and Drug Administration.
Medical Editor: Melissa Conrad Stöppler, MD.
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Skin and Appendages Disorders: acne flare, alopecia, xeroderma, dermatitis contact, flushing, pruritus, pustular reaction, skin burns, skin disorder.
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. 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. 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.
Last reviewed on RxList 4/2/2015.
Less serious side effects may include:
Hearing and Vestibular Disorders: vertigo, otitis, earache, motion sickness.
Hepatic: Hepatomegaly, transient elevations of serum transaminases and alkaline phosphatase.
Neurologic: Abnormal eye movements, aphonia, choreiform movements, coma, diplopia, dysarthria, dysdiadochokinesis, ''glassy-eyed'' appearance, headache, hemiparesis, hypotonia, nystagmus, respiratory depression, slurred speech, tremor, vertigo.
Musculoskeletal: Muscle weakness, pains.
Miscellaneous: Dehydration, general deterioration, fever, lymphadenopathy, weight loss or gain.
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.
In some cases, these may diminish with time; behavior problems have been noted in approximay 25% of patients. The most frequently occurring side effects of Klonopin are referable to CNS depression. Others, listed by system, are:. Experience in treatment of seizures has shown that drowsiness has occurred in approximay 50% of patients and ataxia in approximay 30%.
What is Patient Information in Detail?
Here is a collection of user reviews for the medication Klonopin sorted by most helpful.
Clonazepam is a Schedule IV controlled substance.
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.
‡ Denominators for events in gender-specific systems are: n=240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female. † Indicates that the p-value for the dose-trend test (Cochran-Man-Haenszel) for adverse event incidence was ≤ 0.10. 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† Ataxia† Dysarthria† Psychiatric Depression Memory Disturbance Nervousness Inlectual Ability Reduced Emotional Lability Libido Decreased Confusion Respiratory System Upper Respiratory Tract 10 10 7 6 8 4 Infection† Sinusitis Rhinitis Coughing Pharyngitis Bronchitis Gastrointestinal System Constipation† Appetite Decreased Abdominal Pain† Body as a Whole Fatigue Allergic Reaction Musculoskeletal Myalgia Resistance Mechanism Disorders Influenza Urinary System Micturition Frequency Urinary Tract Infectionf Vision Disorders Blurred Vision Reproductive Disorders} Female Dysmenorrhea Colpitis Male Ejaculation Delayed Impotence * Events reported by at least 1% of patients treated with Klonopin and for which the incidence was greater than that for placebo.
Read the FDA Approves Aptiom to Treat Seizures in Adults article »
Dermatologic: Hair loss, hirsutism, skin rash, ankle and facial edema.
Vascular (Extracardiac) Disorders: thrombophlebitis leg.
Klonopin dose depends on the condition being treated and how the patient responds. If Klonopin is discontinued abruptly after long term use, it may lead to seizures, tremors, muscle cramping, vomiting, and/or sweating. Klonopin use during pregnancy may cause adverse effects in the fetus and it is secreted in breast milk. Drug interactions include alcohol, barbiturates, and narcotics.
Respiratory: Chest congestion, rhinorrhea, shortness of breath, hypersecretion in upper respiratory passages Cardiovascular: Palpitations.
Read the Klonopin User Reviews »
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.
Call your doctor for medical advice about side effects. This is not a complete list of side effects and others may occur. You may report side effects to FDA at 1-800-FDA-1088.
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.
l 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 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. If you notice other effects not listed above, contact your doctor or pharmacist. A very serious allergic reaction to this drug is rare. You may report side effects to Health Canada at. 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. In the US - Call your doctor for medical advice about side effects. l 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. In Canada - Call your doctor for medical advice about side effects. This is not a complete list of possible side effects. 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. Read the entire patient information overview for Klonopin (Clonazepam). You may report side effects to FDA at 1-800-FDA-1088.
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.
Read the entire FDA prescribing information for Klonopin (Clonazepam).
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 acuy life-threatening. 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. It is important to emphasize that, although the events occurred during treatment with Klonopin, they were not necessarily caused by it.
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:.
Urinary System Disorders: dysuria, cystitis, polyuria, urinary incontinence, bladder dysfunction, urinary retention, urinary tract bleeding, urine discoloration.
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 accuray estimate the risks of withdrawal symptoms and dependence that may be associated with such use.
A concise overview of the drug for the patient or caregiver from First DataBank.
Vision Disorders: eye irritation, visual disturbance, diplopia, eye twitching, styes, visual field defect, xerophthalmia.
The following paradoxical reactions have been observed: excitability, irritability, aggressive behavior, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares and vivid dreams. 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 adverse experiences for Klonopin are provided separay for patients with seizure disorders and with panic disorder.
Read the entire detailed patient monograph for Klonopin (Clonazepam).
Gastrointestinal System Disorders: abdominal discomfort, gastrointestinal inflammation, stomach upset, toothache, flatulence, pyrosis, saliva increased, tooth disorder, bowel movements frequent, pain pelvic, dyspepsia, hemorrhoids.
Find tips and treatments to control seizures.
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. 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.Clonazepam