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PROTONIX

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Protonix Adverse Events Reported to the FDA Over Time

How are Protonix adverse event reports trending over time?

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

Most Common Protonix Adverse Events Reported to the FDA

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

Drug Ineffective
501 (2.11%)
Nausea
352 (1.48%)
Drug Interaction
275 (1.16%)
Vomiting
270 (1.14%)
Malaise
259 (1.09%)
Diarrhoea
251 (1.06%)
Abdominal Pain Upper
212 (.89%)
Gastrooesophageal Reflux Disease
208 (.88%)
Death
196 (.83%)
Pruritus
193 (.81%)
Dyspnoea
190 (.8%)
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Headache
186 (.78%)
Condition Aggravated
182 (.77%)
Dizziness
182 (.77%)
Rash
167 (.7%)
Renal Failure Acute
160 (.67%)
Cerebrovascular Accident
152 (.64%)
Fatigue
152 (.64%)
Pyrexia
144 (.61%)
Dyspepsia
141 (.59%)
Pain
141 (.59%)
Weight Decreased
141 (.59%)
Asthenia
137 (.58%)
Hypertension
137 (.58%)
Thrombocytopenia
133 (.56%)
Fall
128 (.54%)
Chest Pain
125 (.53%)
Confusional State
125 (.53%)
Hyponatraemia
124 (.52%)
Abdominal Pain
123 (.52%)
Suicide Attempt
120 (.51%)
Anaemia
118 (.5%)
Drug Screen Positive
116 (.49%)
Arthralgia
113 (.48%)
Renal Failure
111 (.47%)
Myocardial Infarction
103 (.43%)
Drug Screen False Positive
102 (.43%)
Alanine Aminotransferase Increased
97 (.41%)
Toxic Epidermal Necrolysis
96 (.4%)
Flatulence
94 (.4%)
General Physical Health Deteriorati...
91 (.38%)
Hypersensitivity
88 (.37%)
Somnolence
87 (.37%)
Agranulocytosis
86 (.36%)
Anxiety
86 (.36%)
Constipation
86 (.36%)
Depression
86 (.36%)
Hypomagnesaemia
86 (.36%)
Abdominal Distension
83 (.35%)
Oedema Peripheral
83 (.35%)
Aspartate Aminotransferase Increase...
82 (.35%)
Drug Rash With Eosinophilia And Sys...
79 (.33%)
Leukopenia
79 (.33%)
Back Pain
77 (.32%)
Gastric Disorder
77 (.32%)
Insomnia
75 (.32%)
Abdominal Discomfort
74 (.31%)
Myalgia
74 (.31%)
Neutropenia
74 (.31%)
Blood Cholesterol Increased
73 (.31%)
Jaundice
73 (.31%)
Product Substitution Issue
72 (.3%)
Stevens-johnson Syndrome
72 (.3%)
Drug Effect Decreased
71 (.3%)
Feeling Abnormal
71 (.3%)
Convulsion
70 (.29%)
Cough
70 (.29%)
Haemoglobin Decreased
70 (.29%)
Hypocalcaemia
70 (.29%)
Hypotension
70 (.29%)
Pain In Extremity
70 (.29%)
Chest Discomfort
68 (.29%)
Loss Of Consciousness
68 (.29%)
Muscle Spasms
66 (.28%)
Tremor
65 (.27%)
Cholestasis
64 (.27%)
Dehydration
64 (.27%)
Dry Mouth
64 (.27%)
Heart Rate Increased
63 (.27%)
Urticaria
63 (.27%)
Completed Suicide
62 (.26%)
Burning Sensation
59 (.25%)
Diabetes Mellitus
59 (.25%)
Rash Maculo-papular
59 (.25%)
Cardiac Disorder
58 (.24%)
Decreased Appetite
58 (.24%)
Erythema
58 (.24%)
Gamma-glutamyltransferase Increased
58 (.24%)
Hyperhidrosis
58 (.24%)
Cytolytic Hepatitis
57 (.24%)
Pancreatitis
57 (.24%)
Vision Blurred
57 (.24%)
Pancytopenia
56 (.24%)
Paraesthesia
56 (.24%)
Toxic Skin Eruption
56 (.24%)
Vertigo
56 (.24%)
Blood Alkaline Phosphatase Increase...
55 (.23%)
Eosinophilia
55 (.23%)
Rash Erythematous
55 (.23%)
Chills
53 (.22%)
Hypokalaemia
53 (.22%)

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

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

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

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

Gastrooesophageal Reflux Disease
4167
Product Used For Unknown Indication
2883
Drug Use For Unknown Indication
2793
Prophylaxis
1191
Prophylaxis Against Gastrointestina...
802
Gastric Disorder
685
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Dyspepsia
624
Gastritis
612
Abdominal Discomfort
233
Gastric Ulcer
225
Abdominal Pain Upper
200
Ulcer
192
Ill-defined Disorder
187
Hiatus Hernia
169
Oesophagitis
163
Gastritis Prophylaxis
157
Gastrointestinal Disorder
156
Helicobacter Infection
116
Barretts Oesophagus
111
Reflux Oesophagitis
99
Nausea
95
Peptic Ulcer
95
Hyperchlorhydria
92
Crohns Disease
89
Gastrointestinal Haemorrhage
85
Gastrointestinal Disorder Therapy
79
Abdominal Pain
67
Gastrooesophageal Reflux Prophylaxi...
53
Antacid Therapy
49
Duodenal Ulcer
46
Helicobacter Gastritis
44
Reflux Gastritis
44
Oesophageal Disorder
41
Pain
36
Gastric Ph Decreased
35
Duodenitis
35
Vomiting
31
Stomach Discomfort
29
Gastrointestinal Ulcer
28
Hypertension
28
Oesophageal Ulcer
25
Gastritis Erosive
24
Unevaluable Event
22
Gastric Haemorrhage
21
Irritable Bowel Syndrome
20
Erosive Oesophagitis
20
Pancreatitis
19
Rheumatoid Arthritis
18
Premedication
18
Flatulence
17
Stress Ulcer
16

Drug Labels

LabelLabelerEffective
ProtonixRebel Distributors Corp28-DEC-10
Protonixdelayed-releaseSTAT RX USA LLC22-JUN-11
Protonixdelayed-releaseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC29-NOV-11
Protonixdelayed-releasePhysicians Total Care, Inc.21-DEC-11
Protonixdelayed-releaseCardinal Health09-MAY-12
Protonix I.v.Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.01-SEP-12
Protonix I.v.Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.01-SEP-12
Protonix I.v.Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.01-SEP-12
Protonix Delayed-releaseWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.31-OCT-12
Protonix I.v.Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.28-FEB-13
Protonixi.v.Cardinal Health10-APR-13
Protonixdelayed-releaseCardinal Health19-APR-13

Protonix Case Reports

What Protonix 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 Protonix. 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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