This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Xenical (Orlistat) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (65)
Death (7)
Life Threatening Events (2)
Reports by Reaction Type
Drug Ineffective (5),
Diarrhoea (5),
Pancreatic Carcinoma (4),
Rectal Haemorrhage (4),
Haematochezia (4),
Insulin Resistance (4),
Hepatic Siderosis (4),
Chills (3),
Pain (3),
Liver Disorder (3),
Blood Pressure Increased (3),
Chest Discomfort (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Xenical (Orlistat). For a complete list or a specific selection of reports, please use the links above.
Possible Xenical side effects in female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-16
Patient: female
Reactions: Faeces Discoloured
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-16
Patient: female
Reactions: Gastrointestinal Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a pharmacist from Switzerland on 2012-08-15
Patient: female
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Alli
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xenical
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Xenical side effects in female
Reported by a pharmacist from Switzerland on 2012-08-15
Patient: female
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Alli
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xenical
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Xenical side effects in female
Reported by a pharmacist from Switzerland on 2012-08-14
Patient: female
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Alli
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xenical
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Xenical side effects in female
Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-10
Patient: female
Reactions: Faeces Discoloured
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a pharmacist from Switzerland on 2012-08-08
Patient: female
Reactions: Pancreatic Carcinoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Alli
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Xenical
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Xenical side effects in 75 year old female
Reported by a consumer/non-health professional from Russian Federation on 2012-07-11
Patient: 75 year old female
Reactions: Gastrointestinal Pain, Steatorrhoea, Spinal Cord Herniation, Abdominal Distension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: male
Reactions: Drug Ineffective, Deep Vein Thrombosis
Drug(s) suspected as cause:
Dyazide
Indication: Hypertension
Xenical
Administration route: Oral
Indication: Weight Decreased
Other drugs received by patient: Accupril; Warfarin Sodium
Possible Xenical side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female
Reactions: Pharyngeal Mass, Blood Urine Present, Paraesthesia Oral, Wheezing, Chromaturia, Rash, Groin Pain, Haematochezia, Dysphonia, Dysuria, Oral Disorder, Unevaluable Event
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a physician from United Kingdom on 2012-06-20
Patient: female
Reactions: Vasculitis
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a physician from Russian Federation on 2012-06-18
Patient: female
Reactions: Cholecystitis
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in 45 year old female
Reported by a pharmacist from Germany on 2012-06-18
Patient: 45 year old female, weighing 87.0 kg (191.4 pounds)
Reactions: Blood Pressure Increased
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-15
Patient: female
Reactions: Jaundice, Malabsorption, Nail Discolouration, Hypovitaminosis, Skin Disorder, Helicobacter Infection, Gastric Disorder, Ill-Defined Disorder, Liver Disorder, Gastric Infection, Dyspepsia, Ocular Icterus, Nail Disorder
Drug(s) suspected as cause:
Alli
Indication: Product Used FOR Unknown Indication
Xenical
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2002-01-01
Possible Xenical side effects in 43 year old male
Reported by a consumer/non-health professional from Russian Federation on 2012-06-15
Patient: 43 year old male
Reactions: Gastrointestinal Pain, Diarrhoea, Chills, Pyrexia
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a pharmacist from Spain on 2012-06-13
Patient: female
Reactions: Anxiety, Drug Ineffective, Vitamin A Decreased, Vitamin E Decreased
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in 50 year old female
Reported by a pharmacist from Greece on 2012-06-07
Patient: 50 year old female
Reactions: Transaminases Increased, Hepatic Steatosis
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in 34 year old female
Reported by a physician from Switzerland on 2012-05-25
Patient: 34 year old female, weighing 85.6 kg (188.3 pounds)
Reactions: Premature Rupture of Membranes, Maternal Exposure During Pregnancy, Premature Labour
Drug(s) suspected as cause:
Escitalopram
Indication: Product Used FOR Unknown Indication
End date: 2011-04-13
Topamax
Administration route: Oral
Indication: Epilepsy
End date: 2011-04-13
Xenical
Indication: Obesity
End date: 2011-04-13
Possible Xenical side effects in female
Reported by a physician from Switzerland on 2012-05-25
Patient: female, weighing 2.9 kg (6.4 pounds)
Reactions: Premature Baby
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
End date: 2011-04-13
Escitalopram
Indication: Foetal Exposure During Pregnancy
End date: 2011-04-13
Xenical
Indication: Foetal Exposure During Pregnancy
End date: 2011-04-13
Possible Xenical side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: female
Reactions: Jaundice, Malabsorption, Hypovitaminosis, Nail Discolouration, Skin Disorder, Helicobacter Infection, Gastric Disorder, Liver Disorder, Gastric Infection, Dyspepsia, Adverse Event, Nail Disorder, Ocular Icterus
Drug(s) suspected as cause:
Alli
Administration route: Oral
Xenical
Indication: Product Used FOR Unknown Indication
Start date: 2002-01-01
Possible Xenical side effects in male
Reported by a pharmacist from United States on 2012-05-18
Patient: male
Reactions: Haematochezia, Product Quality Issue, Abdominal Discomfort
Drug(s) suspected as cause:
Xenical
Other drugs received by patient: Aspirin; Metformin HCL; Lisinopril; Glipizide
Possible Xenical side effects in female
Reported by a physician from United Kingdom on 2012-05-16
Patient: female
Reactions: Cholecystectomy
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a pharmacist from France on 2012-05-16
Patient: female, weighing 70.0 kg (154.0 pounds)
Reactions: Haematochezia, Diarrhoea, Intentional Drug Misuse
Drug(s) suspected as cause:
Xenical
Other drugs received by patient: Moduretic 5-50; Abufene
Possible Xenical side effects in male
Reported by a consumer/non-health professional from South Africa on 2012-05-08
Patient: male
Reactions: Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in 43 year old female
Reported by a consumer/non-health professional from Russian Federation on 2012-05-01
Patient: 43 year old female
Reactions: Tooth Loss
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in 34 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30
Patient: 34 year old female, weighing 81.6 kg (179.6 pounds)
Reactions: Vomiting, Nausea, Salivary Hypersecretion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in male
Reported by a pharmacist from United Kingdom on 2012-04-27
Patient: male
Reactions: Chest Discomfort, Pain, Vision Blurred
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in male
Reported by a pharmacist from United Kingdom on 2012-04-26
Patient: male
Reactions: Chest Discomfort, Pain, Vision Blurred
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in
Reported by a consumer/non-health professional from Georgia on 2012-04-19
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Xenical
Possible Xenical side effects in female
Reported by a pharmacist from France on 2012-04-11
Patient: female
Reactions: Haematochezia, Diarrhoea
Drug(s) suspected as cause:
Xenical
Other drugs received by patient: Moduretic 5-50; Abufene
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