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Xenical (Orlistat) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials

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 XENICAL 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 XENICAL 120 mg group that is at least twice that of placebo.)

Table 4 Commonly Observed Adverse Events
Adverse Event Year 1 Year 2
XENICAL 1 % Patients
(N=1913)
Placebo % Patients
(N=1466)
XENICAL % Patients
(N=613)
Placebo % Patients
(N=524)
Oily Spotting 2 26.6 1.3 4.4 0.2
Flatus with Discharge 23.9 1.4 2.1 0.2
Fecal Urgency 22.1 6.7 2.8 1.7
Fatty/Oily Stool 20.0 2.9 5.5 0.6
Oily Evacuation 11.9 0.8 2.3 0.2
Increased Defecation 10.8 4.1 2.6 0.8
Fecal Incontinence 7.7 0.9 1.8 0.2

1 Treatment designates XENICAL three times a day plus diet or placebo plus diet
2 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 XENICAL 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 XENICAL discontinued treatment due to adverse events, compared with 5.0% of placebo-treated patients. For XENICAL, 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 XENICAL 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 5 Other Treatment-Emergent Adverse Events From Seven Placebo-Controlled Clinical Trials
Body System/Adverse Event Year 1 Year 2
XENICAL 1 % Patients
(N=1913)
Placebo % Patients
(N=1466)
XENICAL % Patients
(N=613)
Placebo % Patients
(N=524)
– None reported at a frequency ≥2% and greater than placebo
Gastrointestinal System
  Abdominal Pain/Discomfort 25.5 21.4
  Nausea 8.1 7.3 3.6 2.7
  Infectious Diarrhea 5.3 4.4
  Rectal Pain/Discomfort 5.2 4.0 3.3 1.9
  Tooth Disorder 4.3 3.1 2.9 2.3
  Gingival Disorder 4.1 2.9 2.0 1.5
  Vomiting 3.8 3.5
Respiratory System
  Influenza 39.7 36.2
  Upper Respiratory Infection 38.1 32.8 26.1 25.8
  Lower Respiratory Infection 7.8 6.6
  Ear, Nose & Throat Symptoms 2.0 1.6
Musculoskeletal System
  Back Pain 13.9 12.1
  Pain Lower Extremities 10.8 10.3
  Arthritis 5.4 4.8
  Myalgia 4.2 3.3
  Joint Disorder 2.3 2.2
  Tendonitis 2.0 1.9
Central Nervous System
  Headache 30.6 27.6
  Dizziness 5.2 5.0
Body as a Whole
  Fatigue 7.2 6.4 3.1 1.7
  Sleep Disorder 3.9 3.3
Skin & Appendages
  Rash 4.3 4.0
  Dry Skin 2.1 1.4
Reproductive, Female
  Menstrual Irregularity 9.8 7.5
  Vaginitis 3.8 3.6 2.6 1.9
Urinary System
  Urinary Tract Infection 7.5 7.3 5.9 4.8
Psychiatric Disorder
  Psychiatric Anxiety 4.7 2.9 2.8 2.1
  Depression 3.4 2.5
Hearing & Vestibular Disorders
  Otitis 4.3 3.4 2.9 2.5
Cardiovascular Disorders
  Pedal Edema 2.8 1.9

1 Treatment designates XENICAL 120 mg three times a day plus diet or placebo 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.

Pediatric Patients

In clinical trials with XENICAL in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of XENICAL. 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 XENICAL 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 XENICAL in postmarketing surveillance, with some of these cases resulting in liver transplant or death [see Warnings and Precautions].
  • Cases of reduced concentrations of cyclosporine have been reported when cyclosporine was co-administered with XENICAL [see Warnings and Precautions and Drug Interactions].
  • Rare cases of hypersensitivity have been reported with the use of XENICAL. Signs and symptoms have included pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported.
  • Reports of decreased prothrombin, increased INR and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been reported in patients treated concomitantly with XENICAL and anticoagulants [see Drug Interactions].
  • Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine [see Drug Interactions].
  • Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease [see Warnings and Precautions].
  • Pancreatitis has been reported with the use of XENICAL 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 XENICAL. Most reports are nonserious; severe or persistent cases should be investigated further.
  • Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs [see Drug Interactions].


REPORTS OF SUSPECTED XENICAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Xenical. The information is not vetted and should not be considered as verified clinical evidence.

Possible Xenical side effects / adverse reactions in 37 year old female

Reported by a pharmacist from Germany on 2011-10-31

Patient: 37 year old female

Reactions: Chills, Menorrhagia

Suspect drug(s):
Xenical



Possible Xenical side effects / adverse reactions in 37 year old female

Reported by a pharmacist from Germany on 2011-11-23

Patient: 37 year old female weighing 125.0 kg (275.0 pounds)

Reactions: Chills, Uterine Haemorrhage

Suspect drug(s):
Xenical



Possible Xenical side effects / adverse reactions in 45 year old male

Reported by a physician from France on 2011-12-02

Patient: 45 year old male

Reactions: Insulin Resistance, Hepatic Siderosis

Suspect drug(s):
Xenical



See index of all Xenical side effect reports >>

Drug label data at the top of this Page last updated: 2014-06-13

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