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SUCRALFATE

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Sucralfate Adverse Events Reported to the FDA Over Time

How are Sucralfate adverse event reports trending over time?

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

Most Common Sucralfate Adverse Events Reported to the FDA

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

Dehydration
20 (2.29%)
Weight Decreased
20 (2.29%)
Constipation
16 (1.83%)
Delirium
15 (1.72%)
Medication Error
14 (1.6%)
Visual Impairment
14 (1.6%)
Leukocytoclastic Vasculitis
13 (1.49%)
Pyrexia
13 (1.49%)
Fatigue
12 (1.37%)
Depression
11 (1.26%)
Cellulitis
10 (1.14%)
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Confusional State
10 (1.14%)
Urinary Tract Infection
10 (1.14%)
Agitation
9 (1.03%)
Decreased Appetite
9 (1.03%)
Erythema Multiforme
9 (1.03%)
Insomnia
9 (1.03%)
Lymphocyte Stimulation Test Positiv...
9 (1.03%)
Nausea
9 (1.03%)
Rash
9 (1.03%)
Diarrhoea
8 (.92%)
Disorientation
8 (.92%)
Haemoglobin Decreased
8 (.92%)
Hallucination, Visual
8 (.92%)
Incorrect Route Of Drug Administrat...
8 (.92%)
Pseudodementia
8 (.92%)
Acute Generalised Exanthematous Pus...
7 (.8%)
Gastritis
7 (.8%)
Scrotal Oedema
7 (.8%)
Vomiting
7 (.8%)
Atrial Fibrillation
6 (.69%)
Drug Exposure During Pregnancy
6 (.69%)
Drug Ineffective
6 (.69%)
Erythema
6 (.69%)
Haematocrit Decreased
6 (.69%)
Hepatic Function Abnormal
6 (.69%)
Memory Impairment
6 (.69%)
Pneumocystis Jiroveci Pneumonia
6 (.69%)
Pruritus
6 (.69%)
Abortion Induced
5 (.57%)
Anaemia
5 (.57%)
Blood Alkaline Phosphatase Increase...
5 (.57%)
Dizziness
5 (.57%)
Drug Toxicity
5 (.57%)
Gastrointestinal Haemorrhage
5 (.57%)
Intra-uterine Death
5 (.57%)
Liver Disorder
5 (.57%)
Malaise
5 (.57%)
Mental Status Changes
5 (.57%)
Oesophagitis
5 (.57%)
Protein Total Decreased
5 (.57%)
Renal Disorder
5 (.57%)
Abdominal Pain
4 (.46%)
Abdominal Pain Upper
4 (.46%)
Alanine Aminotransferase Increased
4 (.46%)
Aspartate Aminotransferase Increase...
4 (.46%)
Bezoar
4 (.46%)
Blood Aluminium Increased
4 (.46%)
Chills
4 (.46%)
Death Neonatal
4 (.46%)
Hepatitis Acute
4 (.46%)
Hypokalaemia
4 (.46%)
Hypotension
4 (.46%)
Inflammation
4 (.46%)
Maternal Drugs Affecting Foetus
4 (.46%)
Abdominal Distension
3 (.34%)
Cardiac Arrest
3 (.34%)
Cerebral Infarction
3 (.34%)
Clostridium Colitis
3 (.34%)
Condition Aggravated
3 (.34%)
Cough
3 (.34%)
Cytomegalovirus Viraemia
3 (.34%)
Death
3 (.34%)
Drug Interaction
3 (.34%)
Enteritis Infectious
3 (.34%)
Feeling Abnormal
3 (.34%)
Gamma-glutamyltransferase Increased
3 (.34%)
Headache
3 (.34%)
Joint Swelling
3 (.34%)
Lethargy
3 (.34%)
Melaena
3 (.34%)
Necrotising Fasciitis
3 (.34%)
Pain
3 (.34%)
Platelet Count Decreased
3 (.34%)
Product Quality Issue
3 (.34%)
Protein-losing Gastroenteropathy
3 (.34%)
Respiratory Failure
3 (.34%)
Shock
3 (.34%)
Sinus Bradycardia
3 (.34%)
Thrombocytopenia
3 (.34%)
Tremor
3 (.34%)
Abdominal Discomfort
2 (.23%)
Abnormal Behaviour
2 (.23%)
Anorexia
2 (.23%)
Aphasia
2 (.23%)
Atrophy
2 (.23%)
Back Pain
2 (.23%)
Blindness Cortical
2 (.23%)
Blister
2 (.23%)
Blood Bilirubin Increased
2 (.23%)
Blood Sodium Decreased
2 (.23%)

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

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

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

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

Drug Use For Unknown Indication
135
Product Used For Unknown Indication
100
Gastritis
80
Gastric Ulcer
56
Gastrooesophageal Reflux Disease
55
Prophylaxis
39
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Dyspepsia
35
Prophylaxis Against Gastrointestina...
33
Gastric Disorder
26
Ulcer
23
Abdominal Pain Upper
15
Gastritis Prophylaxis
15
Gastrointestinal Disorder
14
Duodenal Ulcer
12
Oesophagitis
9
Stomatitis
9
Gastritis Erosive
7
Peptic Ulcer
7
Oesophageal Ulcer
6
Gastrointestinal Haemorrhage
5
Crohns Disease
5
Erythema Multiforme
4
Reflux Oesophagitis
4
Drug Exposure During Pregnancy
4
Gastroduodenal Ulcer
4
Irritable Bowel Syndrome
4
Hiatus Hernia
4
Hyperchlorhydria
4
Colitis Ulcerative
4
Stomach Discomfort
4
Erosive Oesophagitis
3
Abdominal Distension
3
Sleep Disorder
3
Ill-defined Disorder
3
Analgesic Therapy
3
Abdominal Discomfort
3
Hypertension
3
Inflammation
3
Nausea
3
Varices Oesophageal
2
Dysphagia
2
Gastrectomy
2
Hyperthermia
2
Myositis
2
Aphasia
2
Reflux Gastritis
2
Mucosal Inflammation
2
Duodenal Ulcer Haemorrhage
2
Influenza
2
Portal Hypertension
2
Infection Prophylaxis
2

Drug Labels

LabelLabelerEffective
SucralfatePharmaceutical Associates, Inc.19-NOV-09
SucralfateLevista, Inc.22-DEC-09
SucralfateNostrum Laboratories, Inc.22-DEC-09
SucralfateSTAT RX USA LLC19-FEB-10
SucralfatePhysicians Total Care, Inc.27-MAY-10
SucralfateState of Florida DOH Central Pharmacy08-JUN-10
SucralfateState of Florida DOH Central Pharmacy08-JUN-10
Sucralfate REMEDYREPACK INC. 29-SEP-10
SucralfateUDL Laboratories, Inc.15-OCT-10
SucralfatePhysicians Total Care, Inc.24-NOV-10
SucralfatePD-Rx Pharmaceuticals, Inc.07-APR-11
SucralfateWatson Laboratories, Inc.07-APR-11
SucralfateCardinal Health24-MAY-11
SucralfateGolden State Medical Supply, Inc.01-JUL-11
SucralfateREMEDYREPACK INC. 21-JUL-11
SucralfateMcKesson Contract Packaging01-DEC-11
SucralfateNCS HealthCare of KY, Inc dba Vangard Labs21-FEB-12
SucralfatePrecision Dose Inc.27-FEB-12
SucralfateCardinal Health27-MAR-12
SucralfateAmerican Health Packaging11-JUL-12
SucralfateTeva Pharmaceuticals USA Inc23-JUL-12
SucralfateVistaPharm, Inc.22-AUG-12
SucralfateBryant Ranch Prepack12-OCT-12
Carafate Aptalis Pharma Inc.04-MAR-13
Carafate Physicians Total Care, Inc.08-MAR-13
SucralfateCardinal Health22-MAR-13
SucralfateTeva Pharmaceuticals USA Inc26-APR-13

Sucralfate Case Reports

What Sucralfate 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 Sucralfate. 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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