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Xenical (Orlistat) - Side Effect Reports to FDA

 
 



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: Gastrointestinal Carcinoma

Adverse event resulted in: death

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: Faeces Discoloured

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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