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Pepcid Adverse Events Reported to the FDA Over Time

How are Pepcid adverse event reports trending over time?

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

Most Common Pepcid Adverse Events Reported to the FDA

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

Liver Disorder
239 (3.03%)
Rhabdomyolysis
221 (2.8%)
Hepatic Function Abnormal
97 (1.23%)
Accidental Overdose
95 (1.2%)
Accidental Drug Intake By Child
92 (1.17%)
Aspartate Aminotransferase Increase...
91 (1.15%)
Drug Ineffective
90 (1.14%)
Alanine Aminotransferase Increased
88 (1.11%)
Interstitial Lung Disease
87 (1.1%)
Vomiting
84 (1.06%)
Platelet Count Decreased
83 (1.05%)
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Pyrexia
74 (.94%)
White Blood Cell Count Decreased
67 (.85%)
Pneumonia
66 (.84%)
Blood Creatine Phosphokinase Increa...
65 (.82%)
Diarrhoea
64 (.81%)
Renal Failure Acute
64 (.81%)
Renal Impairment
64 (.81%)
Drug Eruption
62 (.79%)
Abdominal Pain Upper
60 (.76%)
Nausea
60 (.76%)
Pancytopenia
60 (.76%)
Anaemia
59 (.75%)
Haemolytic Anaemia
57 (.72%)
Stevens-johnson Syndrome
54 (.68%)
Toxic Epidermal Necrolysis
53 (.67%)
Drug Interaction
52 (.66%)
Depressed Level Of Consciousness
51 (.65%)
Dyspnoea
51 (.65%)
Disseminated Intravascular Coagulat...
48 (.61%)
Agranulocytosis
47 (.6%)
Gamma-glutamyltransferase Increased
45 (.57%)
Sepsis
45 (.57%)
Blood Alkaline Phosphatase Increase...
43 (.54%)
Blood Bilirubin Increased
43 (.54%)
Overdose
43 (.54%)
Rash
43 (.54%)
Electrocardiogram Qt Prolonged
41 (.52%)
Malaise
41 (.52%)
Thrombocytopenia
41 (.52%)
Erythema Multiforme
39 (.49%)
Multi-organ Failure
39 (.49%)
Ventricular Tachycardia
39 (.49%)
Hypertension
38 (.48%)
Atrioventricular Block Complete
37 (.47%)
Dizziness
35 (.44%)
Blood Lactate Dehydrogenase Increas...
34 (.43%)
Blood Pressure Decreased
34 (.43%)
Convulsion
34 (.43%)
Loss Of Consciousness
34 (.43%)
Cardiac Failure
32 (.41%)
Hyponatraemia
32 (.41%)
Altered State Of Consciousness
30 (.38%)
Myalgia
30 (.38%)
Renal Failure
30 (.38%)
Aplastic Anaemia
29 (.37%)
Hypoglycaemia
29 (.37%)
Neutrophil Count Decreased
27 (.34%)
Shock
27 (.34%)
Torsade De Pointes
27 (.34%)
Asthenia
26 (.33%)
Blood Pressure Increased
26 (.33%)
Dehydration
26 (.33%)
Delirium
26 (.33%)
Pruritus
25 (.32%)
Anaphylactic Shock
24 (.3%)
Chest Pain
24 (.3%)
Depression
24 (.3%)
Drug Exposure During Pregnancy
24 (.3%)
Haemoglobin Decreased
24 (.3%)
Hepatitis Acute
24 (.3%)
Hypersensitivity
24 (.3%)
Somnolence
23 (.29%)
Ventricular Fibrillation
23 (.29%)
Atrial Fibrillation
22 (.28%)
Heart Rate Increased
22 (.28%)
Lymphocyte Stimulation Test Positiv...
22 (.28%)
Diabetes Mellitus
21 (.27%)
Jaundice
21 (.27%)
Tubulointerstitial Nephritis
21 (.27%)
Urticaria
21 (.27%)
Cardiac Arrest
20 (.25%)
Constipation
20 (.25%)
Death
20 (.25%)
Drug Hypersensitivity
20 (.25%)
Granulocytopenia
20 (.25%)
Haematochezia
20 (.25%)
Product Contamination
20 (.25%)
Acute Respiratory Distress Syndrome
19 (.24%)
Angioedema
19 (.24%)
Anorexia
19 (.24%)
Condition Aggravated
19 (.24%)
Confusional State
19 (.24%)
Decreased Appetite
19 (.24%)
Diarrhoea Haemorrhagic
19 (.24%)
Insomnia
19 (.24%)
Long Qt Syndrome
19 (.24%)
Lung Disorder
19 (.24%)
Pleural Effusion
19 (.24%)
Abdominal Pain
18 (.23%)
Bradycardia
18 (.23%)

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

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

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

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

Gastrooesophageal Reflux Disease
477
Product Used For Unknown Indication
374
Drug Use For Unknown Indication
365
Gastritis
358
Dyspepsia
239
Gastric Ulcer
212
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Premedication
210
Prophylaxis
142
Prophylaxis Against Gastrointestina...
117
Abdominal Pain Upper
72
Gastric Disorder
54
Abdominal Discomfort
51
Accidental Exposure
49
Reflux Oesophagitis
44
Ulcer
37
Duodenal Ulcer
32
Abdominal Pain
31
Nausea
29
Gastric Ulcer Haemorrhage
27
Gastrointestinal Haemorrhage
25
Gastrointestinal Disorder
24
Gastroenteritis
22
Gastritis Prophylaxis
19
Upper Gastrointestinal Haemorrhage
19
Peptic Ulcer
17
Hyperchlorhydria
16
Hiatus Hernia
15
Stomach Discomfort
14
Gastritis Erosive
14
Pancreatitis Acute
10
Flatulence
10
Hypersensitivity
10
Crohns Disease
9
Antacid Therapy
9
Stress Ulcer
7
Gastrointestinal Ulcer
7
Gastroduodenal Ulcer
7
Oesophagitis
6
Nasopharyngitis
6
Gastrooesophageal Reflux Prophylaxi...
6
Allergy Prophylaxis
6
Pneumonia Aspiration
6
Anaesthetic Premedication
5
Vomiting
5
Gastrointestinal Disorder Postopera...
5
Diarrhoea
5
Pancreatitis Chronic
4
Rash
4
Pancreatitis Relapsing
4
Foetal Exposure During Pregnancy
4
Reflux Gastritis
4

Drug Labels

LabelLabelerEffective
PepcidPD-Rx Pharmaceuticals, Inc.26-OCT-10
PepcidMerck Sharp & Dohme Corp.26-OCT-10
Pepcid Ac Maximum StrengthJohnson & Johnson Merck Consumer Pharmaceuticals01-DEC-10
Pepcid Ac Original StrengthJohnson & Johnson Merck Consumer Pharmaceuticals03-MAR-11
PepcidMarathon Pharmaceuticals, LLC31-OCT-11
PepcidMarathon Pharmaceuticals, LLC09-JAN-12
PepcidSalix Pharmaceuticals, Inc.13-FEB-12
Pepcid Ac Maximum StrengthMcNeil Consumer Pharmaceuticals Co.10-OCT-12
Pepcid AcMcNeil Consumer Pharmaceuticals Co.18-OCT-12

Pepcid Case Reports

What Pepcid 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 Pepcid. 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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