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Creon Adverse Events Reported to the FDA Over Time

How are Creon adverse event reports trending over time?

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

Most Common Creon Adverse Events Reported to the FDA

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

Diarrhoea
105 (4.73%)
Abdominal Pain
56 (2.52%)
Weight Decreased
50 (2.25%)
Drug Ineffective
48 (2.16%)
Nausea
47 (2.12%)
Vomiting
44 (1.98%)
Flatulence
38 (1.71%)
Distal Intestinal Obstruction Syndr...
32 (1.44%)
Abdominal Pain Upper
31 (1.4%)
Abdominal Distension
28 (1.26%)
Constipation
27 (1.22%)
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Pyrexia
23 (1.04%)
Dizziness
19 (.86%)
Pancreatitis Acute
17 (.77%)
Steatorrhoea
17 (.77%)
Dehydration
16 (.72%)
Dyspepsia
16 (.72%)
Dyspnoea
16 (.72%)
Gastrointestinal Disorder
15 (.68%)
Malnutrition
15 (.68%)
Blood Pressure Increased
14 (.63%)
Headache
14 (.63%)
Insomnia
14 (.63%)
Pain
14 (.63%)
Asthenia
13 (.59%)
Jaundice
13 (.59%)
Metastases To Liver
13 (.59%)
Blood Glucose Increased
12 (.54%)
Pancreatic Carcinoma Recurrent
12 (.54%)
Abnormal Faeces
11 (.5%)
Back Pain
11 (.5%)
Condition Aggravated
11 (.5%)
Off Label Use
11 (.5%)
Pancreatitis
11 (.5%)
Cholangitis
10 (.45%)
Coma
10 (.45%)
Faeces Discoloured
10 (.45%)
Feeling Abnormal
10 (.45%)
Incorrect Dose Administered
10 (.45%)
Peritonitis
10 (.45%)
Rash
10 (.45%)
Weight Increased
10 (.45%)
Anaemia
9 (.41%)
Bone Marrow Failure
9 (.41%)
Gastrooesophageal Reflux Disease
9 (.41%)
Hypertension
9 (.41%)
Malaise
9 (.41%)
Pneumonia
9 (.41%)
Pruritus
9 (.41%)
Bacterial Infection
8 (.36%)
Cardiac Arrest
8 (.36%)
Colitis
8 (.36%)
Death
8 (.36%)
Decreased Appetite
8 (.36%)
Fibrosing Colonopathy
8 (.36%)
Frequent Bowel Movements
8 (.36%)
Gallbladder Disorder
8 (.36%)
Gastric Cancer
8 (.36%)
Gastritis
8 (.36%)
Hepatic Enzyme Increased
8 (.36%)
Hospitalisation
8 (.36%)
Hypoglycaemia
8 (.36%)
Intestinal Perforation
8 (.36%)
Large Intestine Perforation
8 (.36%)
Lip Swelling
8 (.36%)
Myocardial Infarction
8 (.36%)
Oedema
8 (.36%)
Cardiac Failure Congestive
7 (.32%)
Cough
7 (.32%)
Drug Administration Error
7 (.32%)
Dysphagia
7 (.32%)
Escherichia Sepsis
7 (.32%)
Fatigue
7 (.32%)
Gout
7 (.32%)
Heart Rate Increased
7 (.32%)
Hydrocephalus
7 (.32%)
Metastatic Neoplasm
7 (.32%)
Multi-organ Failure
7 (.32%)
Oedema Peripheral
7 (.32%)
Pain In Extremity
7 (.32%)
Reflux Oesophagitis
7 (.32%)
Urinary Tract Infection
7 (.32%)
Anorexia
6 (.27%)
Ascites
6 (.27%)
Burning Sensation
6 (.27%)
Catheter Site Pain
6 (.27%)
Cerebral Haemorrhage
6 (.27%)
Diabetes Mellitus
6 (.27%)
Erythema
6 (.27%)
Gastric Disorder
6 (.27%)
Gastric Ulcer
6 (.27%)
Glucose Urine Present
6 (.27%)
Hepatic Failure
6 (.27%)
Intestinal Mucosal Hypertrophy
6 (.27%)
Medication Error
6 (.27%)
Neoplasm Malignant
6 (.27%)
Night Sweats
6 (.27%)
Pancreatic Disorder
6 (.27%)
Sepsis
6 (.27%)
Septic Shock
6 (.27%)
Weight Fluctuation
6 (.27%)

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

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

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

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

Pancreatic Insufficiency
212
Product Used For Unknown Indication
184
Drug Use For Unknown Indication
101
Cystic Fibrosis
77
Pancreatitis
65
Pancreatitis Chronic
60
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Dyspepsia
52
Pancreatic Disorder
48
Ill-defined Disorder
35
Pancreatectomy
24
Pancreatic Carcinoma
23
Diarrhoea
23
Malabsorption
21
Cystic Fibrosis Pancreatic
20
Enzyme Supplementation
19
Pancreatic Enzymes
18
Gastrointestinal Disorder
17
Crohns Disease
17
Pancreatic Enzyme Abnormality
13
Irritable Bowel Syndrome
11
Pancreatic Enzymes Decreased
10
Coeliac Disease
10
Prophylaxis
7
Pancreaticoduodenectomy
6
Pancreatic Atrophy
5
Gastric Disorder
4
Steatorrhoea
4
Diabetes Mellitus
4
Pancreatitis Acute
4
Hot Flush
4
Inflammation
3
Pancreatic Mass
3
Malignant Neoplasm Of Ampulla Of Va...
3
Flatulence
3
Pancreatic Cyst
3
Cholangitis Sclerosing
3
Pancreatic Enzymes Abnormal
3
Abdominal Pain Upper
3
Pancreatic Neoplasm
3
Abdominal Pain
2
Gastrointestinal Carcinoma
2
Respiratory Tract Infection
2
Pancreas Divisum
2
Enzyme Abnormality
2
Nutritional Support
2
Carotene Decreased
2
Drug Exposure During Pregnancy
2
Unevaluable Event
2
Cholecystectomy
1
Pain
1
Pancreatolithiasis
1

Drug Labels

LabelLabelerEffective
CreonAtlantic Biologicals Corps27-JAN-12
CreonAtlantic Biologicals Corps27-JAN-12
CreonAtlantic Biologicals Corps27-JAN-12
CreonPhysicians Total Care, Inc.06-FEB-12
CreonAbbVie Inc.19-MAR-13

Creon Case Reports

What Creon 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 Creon. 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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