severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or
nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
The following side effects occur commonly with the use of Obezita. They are the natural effects of Obezita's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with Obezita:
oily spotting in your undergarments;
oily or fatty stools;
orange or brown colored oil in your stool;
gas with discharge, an oily discharge;
loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;
an increased number of bowel movements;
stomach pain, nausea, vomiting, diarrhea, rectal pain; or
weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).
Other side effects that may occur while taking Obezita include:
problems with your teeth or gums;
cold symptoms such as stuffy nose, sneezing, cough;
fever, chills, sore throat, flu symptoms;
headache, back pain; or
mild skin rash.
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 Obezita 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.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
Commonly Observed (based on first year and second year data)
Gastrointestinal (GI) symptoms were the most commonly observed treatment-emergent adverse events associated with the use of Obezita in the seven double-blind, placebo-controlled clinical trials and are primarily a manifestation of the mechanism of action. (Commonly observed is defined as an incidence of ≥ 5% and an incidence in the Obezita 120 mg group that is at least twice that of placebo.)
Table 2 : Commonly Observed Adverse Events
Obezita* % Patients
Placebo* % Patients
Obezita* % Patients
Placebo* % Patients
Flatus with Discharge
*Treatment designates Obezita three times a day plus diet or placebo plus diet
†Oily discharge may be clear or have a coloration such as orange or brown.
In general, the first occurrence of these events was within 3 months of starting therapy. Overall, approximately 50% of all episodes of GI adverse events associated with Obezita treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. However, GI adverse events may occur in some individuals over a period of 6 months or longer.
Discontinuation Of Treatment
In controlled clinical trials, 8.8% of patients treated with Obezita discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For Obezita, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
Other Adverse Clinical Events
The following table lists other treatment-emergent adverse events from seven multicenter, double-blind, placebo-controlled clinical trials that occurred at a frequency of ≥ 2% among patients treated with Obezita 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication.
Table 3 : Other Treatment-Emergent Adverse Events From Seven Placebo-Controlled Clinical Trials
Obezita* % Patients
Placebo* % Patients
Obezita* % Patients
Placebo* % Patients
Upper Respiratory Infection
Lower Respiratory Infection
Ear, Nose & Throat Symptoms
Pain Lower Extremities
Central Nervous System
Body as a Whole
Skin & Appendages
Urinary T ract Infection
Hearing & Vestibular Disorders
- None reported at a frequency ≥ 2% and greater than placebo
* Treatment designates Obezita 120 mg three times a day plus diet or placebo plus diet
Table 4 illustrates the percentage of adult patients on Obezita and placebo who developed a low vitamin level on two or more consecutive visits during 1 and 2 years of therapy in studies in which patients were not previously receiving vitamin supplementation.
Table 4 : Incidence of Low Vitamin Values on Two or More Consecutive Visits (Nonsupplemented Adult Patients With Normal Baseline Values - Firs t and Second Year)
* Treatment designates placebo plus diet or Obezita plus diet
Table 5 illustrates the percentage of adolescent patients on Obezita and placebo who developed a low vitamin level on two or more consecutive visits during the 1-year study.
Table 5 : Incidence of Low Vitamin Values on Two or More Consecutive Vis its (Pediatric Patients With Normal Baseline Values*)
*All patients were treated with vitamin supplementation throughout the course of the study
†Treatment designates placebo plus diet or Obezita plus diet
In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.
In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
In clinical trials with Obezita in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.
The following adverse reactions have been identified during postapproval use of Obezita. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to Obezita exposure.
Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of Obezita in postmarketing surveillance, with some of these cases resulting in liver transplant or death.
Rare cases of hypersensitivity have been reported with the use of Obezita. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported.
Rare cases of leukocytoclastic vasculitis have been reported. Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption.
Acute oxalate nephropathy after treatment with Obezita has been reported in patients with or at risk for renal disease.
Pancreatitis has been reported with the use of Obezita in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
Lower gastrointestinal bleeding has been reported in patients treated with Obezita. Most reports are nonserious; severe or persistent cases should be investigated further.
What is the most important information I should know about Obezita?
Do NOT take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may not help you lose more weight. It may increase your risk of side effects.
Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
Obezita may cause changes in your bowel or stool (eg, gas with oily spotting, loose stools, more frequent stools). Eating a low-fat diet may help lessen these side effects.
Tell your doctor or dentist that you take Obezita before you receive any medical or dental care, emergency care, or surgery.
Medicines used to treat seizures may not work as well while taking Obezita. Call your doctor right away if your seizures happen more often or get worse while taking Obezita.
Diabetes patients - Obezita may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
Rarely, some patients taking Obezita have developed severe liver problems. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, unusual weakness, loss of appetite, or severe or persistent nausea.
Obezita should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not take Obezita if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Obezita is found in breast milk. If you are or will be breast-feeding while you take Obezita, check with your doctor. Discuss any possible risks to your baby.
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.
Do not take Obezita if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese.
You should not take this medication if you are allergic to Obezita, if you are pregnant, or if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).
Before taking Obezita, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver or kidney disease, or if you take other weight-loss medications (prescription or over-the-counter).
Do not give over-the-counter Obezita to a child younger than 18 years old. Prescription Obezita should not be used by anyone age 12 to 18 without the advice of a doctor.
Obezita should be used only by the person for whom it was prescribed. Never share Obezita with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.
Obezita is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.
Avoid a diet that is high in fat. High-fat meals taken in combination with Obezita can increase your risk of unpleasant side effects on your stomach or intestines.
DailyMed. "ORLISTAT: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "(S)-1-[[(2S,3S)-3-Hexyl-4-oxo-2-oxetanyl]methyl]-dodecyl-(S)-2-formamido-4-methylvalerat: 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).
The results of a survey conducted on ndrugs.com for Obezita 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 Obezita. 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.
1 consumer reported side effects
Did you experience side effects while taking Obezita drug? According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Obezita drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
No side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology