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Dexilant Adverse Events Reported to the FDA Over Time

How are Dexilant adverse event reports trending over time?

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

Most Common Dexilant Adverse Events Reported to the FDA

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

Diarrhoea
32 (3.21%)
Dizziness
28 (2.81%)
Dyspnoea
21 (2.11%)
Nausea
18 (1.81%)
Abdominal Pain Upper
17 (1.71%)
Headache
17 (1.71%)
Vomiting
16 (1.6%)
Rash
15 (1.5%)
Drug Ineffective
13 (1.3%)
Fatigue
13 (1.3%)
Arthralgia
12 (1.2%)
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Asthenia
12 (1.2%)
Oropharyngeal Pain
12 (1.2%)
Pain
12 (1.2%)
Chest Discomfort
10 (1%)
Gastrooesophageal Reflux Disease
10 (1%)
Malaise
10 (1%)
Amenorrhoea
9 (.9%)
Liver Injury
9 (.9%)
Alanine Aminotransferase Increased
8 (.8%)
Aspartate Aminotransferase Increase...
8 (.8%)
Chills
8 (.8%)
Muscle Spasms
8 (.8%)
Palpitations
8 (.8%)
Urticaria
8 (.8%)
Abdominal Distension
7 (.7%)
Chest Pain
7 (.7%)
Condition Aggravated
7 (.7%)
Constipation
7 (.7%)
Dyspepsia
7 (.7%)
Flatulence
7 (.7%)
Convulsion
6 (.6%)
Depression
6 (.6%)
Drug Hypersensitivity
6 (.6%)
Dysgeusia
6 (.6%)
Heart Rate Irregular
6 (.6%)
Loss Of Consciousness
6 (.6%)
Myalgia
6 (.6%)
Throat Tightness
6 (.6%)
Abdominal Discomfort
5 (.5%)
Abdominal Pain
5 (.5%)
Back Pain
5 (.5%)
Blood Pressure Increased
5 (.5%)
Cough
5 (.5%)
Glossodynia
5 (.5%)
Haemorrhage
5 (.5%)
Heart Rate Increased
5 (.5%)
Insomnia
5 (.5%)
Pyrexia
5 (.5%)
Thrombosis
5 (.5%)
Tremor
5 (.5%)
Vision Blurred
5 (.5%)
Anxiety
4 (.4%)
Blood Glucose Increased
4 (.4%)
Blood Pressure Decreased
4 (.4%)
Confusional State
4 (.4%)
Dehydration
4 (.4%)
Drug Effect Delayed
4 (.4%)
Drug Name Confusion
4 (.4%)
Dry Mouth
4 (.4%)
Dysphonia
4 (.4%)
Feeling Abnormal
4 (.4%)
Gastric Disorder
4 (.4%)
Head Injury
4 (.4%)
Hot Flush
4 (.4%)
Hypersensitivity
4 (.4%)
Inappropriate Schedule Of Drug Admi...
4 (.4%)
Infection
4 (.4%)
Liver Function Test Abnormal
4 (.4%)
Nasopharyngitis
4 (.4%)
Pruritus
4 (.4%)
Weight Decreased
4 (.4%)
Abasia
3 (.3%)
Alopecia
3 (.3%)
Balance Disorder
3 (.3%)
Bone Pain
3 (.3%)
Bronchospasm
3 (.3%)
Cardiac Disorder
3 (.3%)
Colitis
3 (.3%)
Contusion
3 (.3%)
Drug Dose Omission
3 (.3%)
Dysphagia
3 (.3%)
Fall
3 (.3%)
Gastritis
3 (.3%)
Haematochezia
3 (.3%)
Hemiparesis
3 (.3%)
Hypoaesthesia Oral
3 (.3%)
Hypotension
3 (.3%)
Lip Swelling
3 (.3%)
Oedema Peripheral
3 (.3%)
Overdose
3 (.3%)
Paraesthesia
3 (.3%)
Skin Exfoliation
3 (.3%)
Sudden Hearing Loss
3 (.3%)
Swelling Face
3 (.3%)
Swollen Tongue
3 (.3%)
Tachycardia
3 (.3%)
Tinnitus
3 (.3%)
Visual Impairment
3 (.3%)
Amnesia
2 (.2%)
Arterial Occlusive Disease
2 (.2%)

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

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

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

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

Gastrooesophageal Reflux Disease
292
Product Used For Unknown Indication
94
Dyspepsia
41
Gastric Disorder
34
Barretts Oesophagus
9
Ulcer
9
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Hyperchlorhydria
7
Oesophagitis
6
Gastric Ulcer
6
Erosive Oesophagitis
5
Abdominal Discomfort
5
Abdominal Pain Upper
5
Hiatus Hernia
5
Gastritis
5
Ulcer Haemorrhage
4
Laryngeal Ulceration
3
Crohns Disease
3
Cough
3
Erosive Duodenitis
3
Oesophageal Disorder
2
Reflux Oesophagitis
2
Gastrointestinal Disorder
2
Reflux Gastritis
2
Abdominal Distension
2
Duodenal Ulcer
2
Flatulence
2
Reflux Laryngitis
2
Antacid Therapy
1
Nausea
1
Gastritis Erosive
1
Prophylaxis
1
Impaired Gastric Emptying
1
Hernia
1
Hypothyroidism
1
Varices Oesophageal
1
Pain
1
Oropharyngeal Pain
1
Gastrointestinal Haemorrhage
1
Eructation
1
Constipation
1
Irritable Bowel Syndrome
1
Anxiety
1
Drug Therapy Changed
1
Gastroenteritis
1
Myalgia
1
Iron Deficiency Anaemia
1
Throat Irritation
1
Abdominal Operation
1
Laryngeal Disorder
1
Oesophageal Spasm
1
Palpitations
1

Drug Labels

LabelLabelerEffective
DexilantPhysicians Total Care, Inc.08-FEB-12
DexilantTakeda Pharmaceuticals America, Inc.30-SEP-12

Dexilant Case Reports

What Dexilant 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 Dexilant. 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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