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Lialda Adverse Events Reported to the FDA Over Time

How are Lialda adverse event reports trending over time?

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

Most Common Lialda Adverse Events Reported to the FDA

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

Pancreatitis
39 (3.67%)
Off Label Use
31 (2.92%)
Diarrhoea
25 (2.35%)
Colitis Ulcerative
23 (2.16%)
Condition Aggravated
20 (1.88%)
Pyrexia
20 (1.88%)
Dyspnoea
18 (1.69%)
Inappropriate Schedule Of Drug Admi...
18 (1.69%)
Abdominal Pain
16 (1.51%)
Drug Ineffective
15 (1.41%)
Pericarditis
13 (1.22%)
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Dehydration
12 (1.13%)
Diarrhoea Haemorrhagic
12 (1.13%)
Vomiting
12 (1.13%)
Weight Decreased
12 (1.13%)
Abdominal Pain Upper
11 (1.03%)
Alopecia
11 (1.03%)
Chest Pain
11 (1.03%)
Headache
10 (.94%)
Colitis
9 (.85%)
Haematochezia
9 (.85%)
Pneumonitis
9 (.85%)
Arthralgia
8 (.75%)
Asthenia
8 (.75%)
Chromaturia
8 (.75%)
Fall
8 (.75%)
Rectal Haemorrhage
8 (.75%)
Abnormal Loss Of Weight
7 (.66%)
Alanine Aminotransferase Increased
7 (.66%)
Drug Prescribing Error
7 (.66%)
Influenza Like Illness
7 (.66%)
Medication Residue
7 (.66%)
Myocarditis
7 (.66%)
Nausea
7 (.66%)
Pancreatitis Acute
7 (.66%)
Rash
7 (.66%)
Anaemia
6 (.56%)
Aspartate Aminotransferase Increase...
6 (.56%)
Death
6 (.56%)
Depression
6 (.56%)
Feeling Abnormal
6 (.56%)
Haemorrhage
6 (.56%)
Jaundice
6 (.56%)
Pain
6 (.56%)
Pruritus
6 (.56%)
Cardiac Failure Congestive
5 (.47%)
Cerebrovascular Accident
5 (.47%)
Chest Discomfort
5 (.47%)
Clostridial Infection
5 (.47%)
Fatigue
5 (.47%)
Haematuria
5 (.47%)
Haemorrhoids
5 (.47%)
Myalgia
5 (.47%)
Myocardial Infarction
5 (.47%)
Palpitations
5 (.47%)
Abdominal Distension
4 (.38%)
Adverse Event
4 (.38%)
Anxiety
4 (.38%)
Arrhythmia
4 (.38%)
Blood Alkaline Phosphatase Increase...
4 (.38%)
Chills
4 (.38%)
Confusional State
4 (.38%)
Cough
4 (.38%)
Drug Interaction
4 (.38%)
Dyspepsia
4 (.38%)
Frequent Bowel Movements
4 (.38%)
Heart Rate Irregular
4 (.38%)
Hepatitis
4 (.38%)
Hepatitis Acute
4 (.38%)
Migraine
4 (.38%)
Multiple Sclerosis
4 (.38%)
Pericardial Effusion
4 (.38%)
Platelet Count Decreased
4 (.38%)
Pneumonia
4 (.38%)
Back Pain
3 (.28%)
Blood Count Abnormal
3 (.28%)
Blood Glucose Increased
3 (.28%)
Cerebral Haemorrhage
3 (.28%)
Constipation
3 (.28%)
Convulsion
3 (.28%)
Dizziness
3 (.28%)
Drug Dose Omission
3 (.28%)
Drug Hypersensitivity
3 (.28%)
Eosinophilic Pneumonia
3 (.28%)
Fluid Retention
3 (.28%)
Gallbladder Disorder
3 (.28%)
Haemoglobin Decreased
3 (.28%)
Heart Rate Increased
3 (.28%)
Hepatic Enzyme Increased
3 (.28%)
Hyperhidrosis
3 (.28%)
Hypotension
3 (.28%)
Hypothyroidism
3 (.28%)
Insomnia
3 (.28%)
International Normalised Ratio Incr...
3 (.28%)
Liver Disorder
3 (.28%)
Malnutrition
3 (.28%)
No Therapeutic Response
3 (.28%)
Panic Attack
3 (.28%)
Renal Failure
3 (.28%)
Tremor
3 (.28%)
Urethral Meatus Stenosis
3 (.28%)

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This graph shows the top adverse events submitted to the FDA for Lialda, 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 Lialda 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 Lialda

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

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This graph shows the top categories of adverse events submitted to the FDA for Lialda, 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 Lialda 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 Lialda According to Those Reporting Adverse Events

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

Colitis Ulcerative
323
Crohns Disease
249
Product Used For Unknown Indication
207
Colitis
71
Drug Use For Unknown Indication
32
Fibromyalgia
9
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Proctitis Ulcerative
8
Irritable Bowel Syndrome
5
Inflammatory Bowel Disease
5
Antiinflammatory Therapy
4
Colon Cancer
4
Prophylaxis
4
Diarrhoea
3
Fistula
2
Gastrointestinal Inflammation
2
Gastrointestinal Disorder
2
Colitis Collagenous
2
Colitis Microscopic
2
Diverticulitis
2
Large Intestinal Ulcer
1
Pain
1
Liver Transplant
1
Proctocolitis
1
Abdominal Discomfort
1
Dyspepsia
1
Proctitis
1
Diverticulum
1
Rheumatoid Arthritis
1
Abdominal Pain
1
Gastric Disorder
1
Ileitis
1
Inflammation
1

Drug Labels

LabelLabelerEffective
LialdaShire US Manufacturing Inc.17-APR-13

Lialda Case Reports

What Lialda 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 Lialda. 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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