Obsenil Side effects

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What are the possible side effects of Obsenil?

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

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

Call your doctor at once if you have:

Common side effects may include:

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.

Side effects of Obsenil in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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Commonly Observed

The most commonly observed adverse events associated with the use of Obsenil and not seen at an equivalent incidence among placebo-treated patients were gastrointestinal complaints, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes.

Leading To Discontinuation Of Treatment

Approximately 20% of 3616 patients who received Obsenil in U.S. premarketing clinical trials discontinued treatment because of an adverse event. Approximately one-half of the patients who discontinued (9% of the total) had multiple complaints, none of which could be classified as primary. Where a primary reason for discontinuation could be identified, most patients discontinued because of nervous system complaints (5.4%), primarily somnolence. The second-most-frequent reason for discontinuation was digestive system complaints (1.3%), primarily vomiting and nausea.

There was no apparent relationship between the adverse events and elevated plasma drug concentrations.

Incidence In Controlled Clinical Trials

The following table enumerates adverse events that occurred at an incidence of 1% or greater among patients with OCD who received Obsenil in adult or pediatric placebo-controlled clinical trials. The frequencies were obtained from pooled data of clinical trials involving either adults receiving Obsenil (N=322) or placebo (N=319) or children treated with Obsenil (N=46) or placebo (N=44). The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice, in which 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, provide the physician with a basis for estimating the relative contribution of drug and nondrug factors to the incidence of side effects in the populations studied.

Incidence of Treatment-Emergent Adverse Experience in Placebo-Controlled Clinical Trials (Percentage of Patients Reporting Event)

Body System/ Adverse Event* Adults Children and Adolescents
Obsenil

(N=322)

Placebo

(N=319)

Obsenil

(N=46)

Placebo

(N=44)

Nervous System
Somnolence 54 16 46 11
Tremor 54 2 33 2
Dizziness 54 14 41 14
Headache 52 41 28 34
Insomnia 25 15 11 7
Libido change 21 3 - -
Nervousness 18 2 4 2
Myoclonus 13 - 2 -
Increased appetite 11 2 - 2
Paresthesia 9 3 2 2
Memory impairment. 9 1 7 2
Anxiety 9 4 2 -
Twitching 7 1 4 5
Impaired concentration 5 2 - -
Depression 5 1 - -
Hypertonia 4 1 2 -
Sleep disorder 4 - 9 5
Psychosomatic disorder 3 - - -
Yawning 3 - - -
Confusion 3 - 2 -
Speech disorder 3 - - -
Abnormal dreaming 3 - - 2
Agitation 3 - - -
Migraine 3 - - -
Depersonalization 2 - 2 -
Irritability 2 2 2 -
Emotional lability 2 - - 2
Panic reaction 1 - 2 -
Aggressive reaction - - 2 -
Paresis - - 2 -
Skin and Appendages
Increased sweating 29 3 9 -
Rash 8 1 4 2
Pruritus 6 - 2 2
Dermatitis 2 - - 2
Acne 2 2 - 5
Dry skin 2 - - 5
Urticaria 1 - - -
Abnormal skin odor - - 2 -
Digestive System
Dry mouth 84 17 63 16
Constipation 47 11 22 9
Nausea 33 14 9 11
Dyspepsia 22 10 13 2
Diarrhea 13 9 7 5
Anorexia 12 - 22 2
Abdominal pain 11 9 13 16
Vomiting 7 2 7 -
Flatulence 6 3 - 2
Tooth disorder 5 - - -
Gastrointestinal disorder 2 - - 2
Dysphagia 2 - - -
Esophagitis 1 - - -
Eructation - - 2 2
Ulcerative stomatitis - - 2 -
Body as a Whole
Fatigue 39 18 35 9
Weight increase 18 1 2 -
Flushing 8 - 7 -
Hot flushes 5 - 2 -
Chest pain 4 4 7 -
Fever 4 - 2 7
Allergy 3 3 7 5
Pain 3 2 4 2
Local edema 2 4 - -
Chills 2 1 - -
Weight decrease - - 7 -
Otitis media - - 4 5
Asthenia - - 2 -
Halitosis - - 2 -
Cardiovascular System
Postural hypotension 6 - 4 -
Palpitation 4 2 4 -
Tachycardia 4 - 2 -
Syncope - - 2 -
Respiratory System
Pharyngitis 14 9 - 5
Rhinitis 12 10 7 9
Sinusitis 6 4 2 5
Coughing 6 6 4 5
Bronchospasm 2 - 7 2
Epistaxis 2 - - 2
Dyspnea - - 2 -
Laryngitis - 1 2 -
Urogenital System
Male and Female Patients C'ombined
Micturition disorder 14 2 4 2
Urinary tract infection 6 1 - -
Micturition frequency 5 3 - -
Urinary retention 2 - 7 -
Dysuria 2 2 - -
Cystitis 2 - - -
Female Patients Only (N=182) (N=167) (N=10) (N=21)
Dysmenorrhea 12 14 10 10
Lactation (nonpuerperal) 4 - - -
Menstrual disorder 4 2 - -
Vaginitis 2 - - -
Leukorrhea 2 - - -
Breast enlargement 2 - - -
Breast pain 1 - - -
Amenorrhea 1 - - -
Male Patients Only (N=140) (N=152) (N=36) (N=23)
Ejaculation failure 42 2 6 -
Impotence 20 3 - -
Special Senses
Abnormal vision 18 4 7 2
Taste perversion 8 - 4 -
Tinnitus 6 - 4 -
Abnormal lacrimation 3 2 - -
Mydriasis 2 - - -
Conjunctivitis 1 - - -
Anisocoria - - 2 -
Blepharospasm - - 2 -
Ocular allergy - - 2 -
Vestibular disorder - - 2 2
Musculoskeletal
Myalgia 13 9 - -
Back pain 6 6 - -
Arthralgia 3 5 - -
Muscle weakness 1 - 2 -
Hemic and Lymphatic
Purpura 3 - - -
Anemia - - 2 2
Metabolic and Nutritional
Thirst 2 2 - 2
*Events reported by at least 1% of Obsenil patients are included.

Other Events Observed During The Premarketing Evaluation Of Obsenil

During clinical testing in the U.S., multiple doses of Obsenil were administered to approximately 3600 subjects. Untoward events associated with this exposure were 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 untoward events into a smaller number of standardized event categories.

In the tabulations that follow, a modified World Health Organization dictionary of terminology has been used to classify reported adverse events. The frequencies presented, therefore, represent the proportion of the 3525 individuals exposed to Obsenil who experienced an event of the type cited on at least one occasion while receiving Obsenil. All events are included except those already listed in the previous table, those reported in terms so general as to be uninformative, and those in which an association with the drug was remote. It is important to emphasize that although the events reported occurred during treatment with Obsenil, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in less than 1/1000 patients.

Body as a Whole – Infrequent - general edema, increased susceptibility to infection, malaise. Rare - dependent edema, withdrawal syndrome.

Cardiovascular System – Infrequent - abnormal ECG, arrhythmia, bradycardia, cardiac arrest, extrasystoles, pallor. Rare - aneurysm, atrial flutter, bundle branch block, cardiac failure, cerebral hemorrhage, heart block, myocardial infarction, myocardial ischemia, peripheral ischemia, thrombophlebitis, vasospasm, ventricular tachycardia.

Digestive System – Infrequent - abnormal hepatic function, blood in stool, colitis, duodenitis, gastric ulcer, gastritis, gastroesophageal reflux, gingivitis, glossitis, hemorrhoids, hepatitis, increased saliva, irritable bowel syndrome, peptic ulcer, rectal hemorrhage, tongue ulceration, tooth caries. Rare - cheilitis, chronic enteritis, discolored feces, gastric dilatation, gingival bleeding, hiccup, intestinal obstruction, oral/pharyngeal edema, paralytic ileus, salivary gland enlargement.

Endocrine System – Infrequent - hypothyroidism. Rare - goiter, gynecomastia, hyperthyroidism.

Hemic and Lymphatic System – Infrequent - lymphadenopathy. Rare - leukemoid reaction, lymphomalike disorder, marrow depression.

Metabolic and Nutritional DisorderInfrequent - dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperuricemia, hypokalemia. Rare - fat intolerance, glycosuria.

Musculoskeletal System – Infrequent - arthrosis. Rare - dystonia, exostosis, lupus erythematosus rash, bruising, myopathy, myositis, polyarteritis nodosa, torticollis.

Nervous System – Frequent - abnormal thinking, vertigo. Infrequent - abnormal coordination, abnormal EEG, abnormal gait, apathy, ataxia, coma, convulsions, delirium, delusion, dyskinesia, dysphonia, encephalopathy, euphoria, extrapyramidal disorder, hallucinations, hostility, hyperkinesia, hypnagogic hallucinations, hypokinesia, leg cramps, manic reaction, neuralgia, paranoia, phobic disorder, psychosis, sensory disturbance, somnambulism, stimulation, suicidal ideation, suicide attempt, teethgrinding. Rare - anticholinergic syndrome, aphasia, apraxia, catalepsy, cholinergic syndrome, choreoathetosis, generalized spasm, hemiparesis, hyperesthesia, hyperreflexia, hypoesthesia, illusion, impaired impulse control, indecisiveness, mutism, neuropathy, nystagmus, oculogyric crisis, oculomotor nerve paralysis, schizophrenic reaction, stupor, suicide.

Respiratory System – Infrequent - bronchitis, hyperventilation, increased sputum, pneumonia. Rare - cyanosis, hemoptysis, hypoventilation, laryngismus.

Skin and Appendages – Infrequent - alopecia, cellulitis, cyst, eczema, erythematous rash, genital pruritus, maculopapular rash, photosensitivity reaction, psoriasis, pustular rash, skin discoloration. Rare - chloasma, folliculitis, hypertrichosis, piloerection, seborrhea, skin hypertrophy, skin ulceration.

Special Senses – Infrequent - abnormal accommodation, deafness, diplopia, earache, eye pain, foreign body sensation, hyperacusis, parosmia, photophobia, scleritis, taste loss. Rare - blepharitis, chromatopsia, conjunctival hemorrhage, exophthalmos, glaucoma, keratitis, labyrinth disorder, night blindness, retinal disorder, strabismus, visual field defect.

Urogenital System – Infrequent - endometriosis, epididymitis, hematuria, nocturia, oliguria, ovariancyst, perineal pain, polyuria, prostatic disorder, renal calculus, renal pain, urethral disorder, urinary incontinence, uterine hemorrhage, vaginal hemorrhage. Rare - albuminuria, anorgasmy, breast engorgement, breast fibroadenosis, cervical dysplasia, endometrial hyperplasia, premature ejaculation, pyelonephritis, pyuria, renal cyst, uterine inflammation, vulvar disorder.

Postmarketing Experience

The following adverse drug reaction has been reported during post-approval use of Obsenil. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate frequency.

Eye Disorders – angle-closure glaucoma.

Drug Abuse And Dependence

Obsenil has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence. While a variety of withdrawal symptoms have been described in association with Obsenil discontinuation, there is no evidence for drug-seeking behavior, except for a single report of potential Obsenil abuse by a patient with a history of dependence on codeine, benzodiazepines, and multiple psychoactive drugs. The patient received Obsenil for depression and panic attacks and appeared to become dependent after hospital discharge.

Despite the lack of evidence suggesting an abuse liability for Obsenil in foreign marketing, it is not possible to predict the extent to which Obsenil might be misused or abused once marketed in the U.S. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely.

What is the most important information I should know about Obsenil?

If you stop taking Obsenil suddenly, you may have WITHDRAWAL symptoms. These may include dizziness, headache, irritability, nausea, tiredness, trouble sleeping, and vomiting.

Obsenil contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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Obsenil is contraindicated in patients with a history of hypersensitivity to Obsenil or other tricyclic antidepressants.

Monoamine Oxidase Inhibitors (MAOIs)

The use of MAOIs intended to treat psychiatric disorders with Obsenil or within 14 days of stopping treatment with Obsenil is contraindicated because of an increased risk of serotonin syndrome. The use of Obsenil within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Starting Obsenil in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome.

Myocardial Infarction

Obsenil is contraindicated during the acute recovery period after a myocardial infarction.

References

  1. DTP/NCI. "clomipramine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  2. European Chemicals Agency - ECHA. "Clomipramine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
  3. HSDB. "Clomipramine". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Obsenil are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Obsenil. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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