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PENTASA

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Pentasa Adverse Events Reported to the FDA Over Time

How are Pentasa adverse event reports trending over time?

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

Most Common Pentasa Adverse Events Reported to the FDA

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

Pyrexia
79 (2.88%)
Diarrhoea
44 (1.6%)
Interstitial Lung Disease
39 (1.42%)
Pancreatitis Acute
32 (1.17%)
Colitis Ulcerative
30 (1.09%)
Off Label Use
30 (1.09%)
Condition Aggravated
29 (1.06%)
Vomiting
29 (1.06%)
Pancreatitis
28 (1.02%)
Arthralgia
27 (.98%)
Abdominal Pain
26 (.95%)
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Drug Exposure During Pregnancy
25 (.91%)
Pneumonia
24 (.88%)
Rash
24 (.88%)
Renal Impairment
24 (.88%)
Alanine Aminotransferase Increased
23 (.84%)
Headache
23 (.84%)
Pericardial Effusion
23 (.84%)
Chest Pain
22 (.8%)
Liver Disorder
22 (.8%)
Pericarditis
22 (.8%)
Eosinophilic Pneumonia
21 (.77%)
Pleural Effusion
21 (.77%)
Drug Interaction
20 (.73%)
Thrombocytopenia
19 (.69%)
C-reactive Protein Increased
18 (.66%)
Dyspnoea
18 (.66%)
Haemoglobin Decreased
16 (.58%)
Hypersensitivity
16 (.58%)
Myocarditis
16 (.58%)
Nausea
16 (.58%)
Aspartate Aminotransferase Increase...
15 (.55%)
Anaemia
14 (.51%)
Oedema Peripheral
14 (.51%)
Asthenia
13 (.47%)
Malaise
13 (.47%)
Myalgia
13 (.47%)
Platelet Count Decreased
13 (.47%)
Renal Failure
13 (.47%)
Back Pain
12 (.44%)
Fatigue
12 (.44%)
Neutropenia
12 (.44%)
Weight Decreased
12 (.44%)
White Blood Cell Count Increased
12 (.44%)
Hepatic Function Abnormal
11 (.4%)
Neck Pain
11 (.4%)
Pleurisy
11 (.4%)
White Blood Cell Count Decreased
11 (.4%)
Alopecia
10 (.36%)
Atrial Fibrillation
10 (.36%)
Chills
10 (.36%)
Drug Ineffective
10 (.36%)
Dry Mouth
10 (.36%)
Hepatomegaly
10 (.36%)
Hypokalaemia
10 (.36%)
Leukopenia
10 (.36%)
Lymphocyte Stimulation Test Positiv...
10 (.36%)
Muscle Spasms
10 (.36%)
Pain In Extremity
10 (.36%)
Blood Creatinine Increased
9 (.33%)
Blood Lactate Dehydrogenase Increas...
9 (.33%)
Caesarean Section
9 (.33%)
Cough
9 (.33%)
Dehydration
9 (.33%)
Disease Recurrence
9 (.33%)
Haematochezia
9 (.33%)
Inflammation
9 (.33%)
Medication Error
9 (.33%)
Pain
9 (.33%)
Pancytopenia
9 (.33%)
Proteinuria
9 (.33%)
Rash Generalised
9 (.33%)
Stomatitis
9 (.33%)
Weight Increased
9 (.33%)
Blood Creatine Phosphokinase Increa...
8 (.29%)
Death
8 (.29%)
Lung Disorder
8 (.29%)
Pneumonitis
8 (.29%)
Pulmonary Fibrosis
8 (.29%)
Sepsis
8 (.29%)
Alveolitis Allergic
7 (.26%)
Blood Alkaline Phosphatase Increase...
7 (.26%)
Blood Amylase Increased
7 (.26%)
Blood Pressure Decreased
7 (.26%)
Cardiac Failure Congestive
7 (.26%)
Drug Administration Error
7 (.26%)
Dysphagia
7 (.26%)
Erythema
7 (.26%)
Flatulence
7 (.26%)
Haematuria
7 (.26%)
Hyperhidrosis
7 (.26%)
Hypoaesthesia
7 (.26%)
Hypotension
7 (.26%)
Irritability
7 (.26%)
Maternal Drugs Affecting Foetus
7 (.26%)
Musculoskeletal Stiffness
7 (.26%)
Systemic Lupus Erythematosus
7 (.26%)
Transaminases Increased
7 (.26%)
Abdominal Pain Upper
6 (.22%)
Aggression
6 (.22%)
Agranulocytosis
6 (.22%)

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

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

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

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

Crohns Disease
1933
Colitis Ulcerative
599
Product Used For Unknown Indication
511
Drug Use For Unknown Indication
184
Inflammatory Bowel Disease
40
Colitis
32
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Behcets Syndrome
24
Gastrointestinal Disorder
14
Abdominal Pain
9
Drug Exposure During Pregnancy
7
Inflammation
6
Antiinflammatory Therapy
6
Enterocolitis
5
Rheumatoid Arthritis
5
Enterocolitis Haemorrhagic
5
Irritable Bowel Syndrome
5
Large Intestinal Ulcer
4
Foetal Exposure During Pregnancy
4
Ill-defined Disorder
4
Gastrointestinal Inflammation
4
Functional Gastrointestinal Disorde...
3
Gastric Disorder
3
Colitis Collagenous
3
Prophylaxis
3
Intestinal Functional Disorder
3
Enteritis
3
Intestinal Villi Atrophy
2
Diarrhoea
2
Coeliac Disease
2
Proctitis
2
Intestinal Obstruction
1
Drug Therapy
1
Gastrointestinal Erosion
1
Ankylosing Spondylitis
1
Food Allergy
1
Gastroenteritis
1
Ileitis
1
Psoriatic Arthropathy
1
Colitis Microscopic
1
Exposure Via Semen
1
Maternal Exposure During Pregnancy
1
Dyspepsia
1
Proctitis Ulcerative
1
Pancreatitis
1
Congenital Cystic Kidney Disease
1
Gastritis
1
Diverticulum
1
Constipation
1
Blood Immunoglobulin G Increased
1
Autism
1
Pancreatitis Acute
1

Drug Labels

LabelLabelerEffective
PentasaPhysicians Total Care, Inc.26-MAY-10
Pentasa REMEDYREPACK INC. 04-OCT-11
PentasaShire US Manufacturing Inc.30-APR-12
PentasaCardinal Health26-JUN-12
PentasaREMEDYREPACK INC. 19-MAR-13

Pentasa Case Reports

What Pentasa 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 Pentasa. 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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