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Alli Adverse Events Reported to the FDA Over Time

How are Alli adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Alli, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Alli is flagged as the suspect drug causing the adverse event.

Most Common Alli Adverse Events Reported to the FDA

What are the most common Alli adverse events reported to the FDA?

Gastrointestinal Disorder
2247 (5.06%)
Drug Ineffective
2070 (4.67%)
Rectal Discharge
1958 (4.41%)
Weight Increased
1769 (3.99%)
Constipation
1704 (3.84%)
Flatulence
1493 (3.36%)
Diarrhoea
1256 (2.83%)
Abdominal Pain Upper
1117 (2.52%)
Abdominal Distension
960 (2.16%)
Headache
960 (2.16%)
Steatorrhoea
889 (2%)
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Malaise
808 (1.82%)
Nausea
781 (1.76%)
Fatigue
553 (1.25%)
Frequent Bowel Movements
484 (1.09%)
Abdominal Pain
482 (1.09%)
Dizziness
482 (1.09%)
Rectal Haemorrhage
437 (.98%)
Muscle Spasms
430 (.97%)
Pain
406 (.92%)
Weight Fluctuation
397 (.89%)
Vomiting
390 (.88%)
Hunger
370 (.83%)
Faeces Discoloured
351 (.79%)
Therapeutic Response Unexpected
347 (.78%)
Feeling Abnormal
333 (.75%)
Food Craving
323 (.73%)
Anorexia
292 (.66%)
Asthenia
289 (.65%)
Haematochezia
275 (.62%)
Ill-defined Disorder
275 (.62%)
Faecal Incontinence
260 (.59%)
Back Pain
251 (.57%)
Adverse Event
232 (.52%)
Defaecation Urgency
225 (.51%)
Insomnia
221 (.5%)
Dyspnoea
208 (.47%)
Migraine
199 (.45%)
Rash
195 (.44%)
Hepatic Enzyme Increased
190 (.43%)
Anxiety
188 (.42%)
Pain In Extremity
187 (.42%)
Gastroenteritis Viral
186 (.42%)
Nasopharyngitis
186 (.42%)
Depression
183 (.41%)
Hyperphagia
176 (.4%)
Fluid Retention
166 (.37%)
Stress
161 (.36%)
Dyspepsia
160 (.36%)
Pruritus
152 (.34%)
Menstrual Disorder
151 (.34%)
Pollakiuria
151 (.34%)
Abnormal Faeces
150 (.34%)
Influenza
144 (.32%)
Change Of Bowel Habit
141 (.32%)
Chest Pain
140 (.32%)
Frustration
140 (.32%)
Oedema Peripheral
140 (.32%)
Arthralgia
138 (.31%)
Hypersensitivity
135 (.3%)
Discomfort
134 (.3%)
Menstruation Irregular
132 (.3%)
Urticaria
127 (.29%)
Cough
124 (.28%)
Pyrexia
124 (.28%)
Nephrolithiasis
122 (.27%)
Menstruation Delayed
115 (.26%)
Loss Of Consciousness
114 (.26%)
Asthma
109 (.25%)
Fear
108 (.24%)
Cholelithiasis
103 (.23%)
Decreased Appetite
102 (.23%)
Nonspecific Reaction
102 (.23%)
Thirst
102 (.23%)
Dehydration
101 (.23%)
Alopecia
99 (.22%)
Infrequent Bowel Movements
97 (.22%)
Gastric Disorder
96 (.22%)
Abdominal Discomfort
95 (.21%)
Anal Haemorrhage
91 (.21%)
Drug Interaction
90 (.2%)
Sinusitis
89 (.2%)
Depressed Mood
86 (.19%)
Increased Appetite
86 (.19%)
Eating Disorder
85 (.19%)
Gallbladder Disorder
85 (.19%)
Myalgia
83 (.19%)
Dysgeusia
81 (.18%)
Blood Pressure Increased
79 (.18%)
Hyperhidrosis
79 (.18%)
Chromaturia
78 (.18%)
Gastrointestinal Sounds Abnormal
78 (.18%)
Vaginal Haemorrhage
77 (.17%)
Hypertension
72 (.16%)
Abdominal Pain Lower
71 (.16%)
Premenstrual Syndrome
71 (.16%)
Joint Swelling
70 (.16%)
Palpitations
70 (.16%)
Product Quality Issue
70 (.16%)
Nervousness
69 (.16%)
Bronchitis
68 (.15%)

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This graph shows the top adverse events submitted to the FDA for Alli, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alli is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Alli

What are the most common Alli adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Alli, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alli is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Alli According to Those Reporting Adverse Events

Why are people taking Alli, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
4506
Weight Loss Diet
1053
Weight Control
199
Weight Decreased
122
Product Used For Unknown Indication
113
Obesity
44
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Overweight
19
Constipation
6
Weight Increased
5
Epigastric Discomfort
3
Change Of Bowel Habit
3
Haematochezia
2
Blood Cholesterol Increased
2
Hyperchlorhydria
2
Diverticulitis
2
Ill-defined Disorder
2
Supplementation Therapy
1
Abnormal Faeces
1
Weight
1
Medical Diet
1
Metabolic Syndrome
1
Accidental Exposure
1
Intentional Drug Misuse
1
Routine Health Maintenance
1
Flatulence
1

Drug Labels

LabelLabelerEffective
AlliGlaxoSmithKline Consumer Healthcare LP10-DEC-12

Alli Case Reports

What Alli safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Alli. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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