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PEPCID AC

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Pepcid Ac Adverse Events Reported to the FDA Over Time

How are Pepcid Ac adverse event reports trending over time?

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

Most Common Pepcid Ac Adverse Events Reported to the FDA

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

Drug Ineffective
29 (3.59%)
Vomiting
29 (3.59%)
Drug Interaction
23 (2.85%)
Abdominal Pain Upper
21 (2.6%)
Nausea
20 (2.48%)
Diarrhoea Haemorrhagic
17 (2.1%)
Accidental Drug Intake By Child
16 (1.98%)
Diarrhoea
16 (1.98%)
Dyspnoea
16 (1.98%)
Product Contamination
15 (1.86%)
Accidental Overdose
14 (1.73%)
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Depression
12 (1.49%)
Pruritus
12 (1.49%)
Atrioventricular Block Complete
11 (1.36%)
Hypersensitivity
11 (1.36%)
Blood Pressure Increased
10 (1.24%)
Dizziness
10 (1.24%)
Insomnia
10 (1.24%)
Overdose
9 (1.11%)
Asthenia
8 (.99%)
Headache
8 (.99%)
Weight Decreased
8 (.99%)
Atrial Fibrillation
7 (.87%)
Drug Exposure During Pregnancy
7 (.87%)
Duodenitis
7 (.87%)
Gamma-glutamyltransferase Increased
7 (.87%)
Hypertension
7 (.87%)
Liver Disorder
7 (.87%)
Malaise
7 (.87%)
Swollen Tongue
7 (.87%)
Throat Tightness
7 (.87%)
Urticaria
7 (.87%)
Chest Pain
6 (.74%)
Cholestasis Of Pregnancy
6 (.74%)
Fall
6 (.74%)
Haematochezia
6 (.74%)
Rash
6 (.74%)
Swelling Face
6 (.74%)
Tinnitus
6 (.74%)
Abasia
5 (.62%)
Dysphagia
5 (.62%)
Feeling Abnormal
5 (.62%)
Hallucination
5 (.62%)
Abdominal Pain
4 (.5%)
Alanine Aminotransferase Increased
4 (.5%)
Aphonia
4 (.5%)
Aplastic Anaemia
4 (.5%)
Arrhythmia
4 (.5%)
Aspartate Aminotransferase Increase...
4 (.5%)
Blindness
4 (.5%)
Blood Alkaline Phosphatase Increase...
4 (.5%)
Blood Lactate Dehydrogenase Increas...
4 (.5%)
Delirium
4 (.5%)
Drug Effect Decreased
4 (.5%)
Dry Throat
4 (.5%)
Gait Disturbance
4 (.5%)
Gynaecomastia
4 (.5%)
Haematemesis
4 (.5%)
Heart Rate Increased
4 (.5%)
Hepatitis Acute
4 (.5%)
Incorrect Dose Administered
4 (.5%)
Intentional Drug Misuse
4 (.5%)
Oedema Peripheral
4 (.5%)
Pharyngeal Erythema
4 (.5%)
Rash Erythematous
4 (.5%)
Suicidal Ideation
4 (.5%)
Syncope
4 (.5%)
Therapeutic Response Delayed
4 (.5%)
Tooth Injury
4 (.5%)
Blood Bilirubin Increased
3 (.37%)
Blood Pressure Systolic Increased
3 (.37%)
Dysphonia
3 (.37%)
Erythema
3 (.37%)
Expressive Language Disorder
3 (.37%)
Gastritis
3 (.37%)
Gastrooesophageal Reflux Disease
3 (.37%)
Heart Rate Decreased
3 (.37%)
Hypoaesthesia
3 (.37%)
Loss Of Consciousness
3 (.37%)
Mental Disorder
3 (.37%)
Myalgia
3 (.37%)
Off Label Use
3 (.37%)
Pallor
3 (.37%)
Pharyngeal Oedema
3 (.37%)
Product Quality Issue
3 (.37%)
Therapeutic Response Unexpected
3 (.37%)
Unresponsive To Stimuli
3 (.37%)
White Blood Cell Count Decreased
3 (.37%)
Abnormal Dreams
2 (.25%)
Albumin Urine Present
2 (.25%)
Amnesia
2 (.25%)
Angioedema
2 (.25%)
Arthralgia
2 (.25%)
Bilirubin Conjugated Increased
2 (.25%)
Blood Cholesterol Increased
2 (.25%)
Blood Potassium Decreased
2 (.25%)
Blood Urine Present
2 (.25%)
Bronchospasm
2 (.25%)
Burning Sensation
2 (.25%)
Cerebrovascular Accident
2 (.25%)
Chondrocalcinosis Pyrophosphate
2 (.25%)

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

What are the most common Pepcid Ac 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 Ac, 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 Ac 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 Ac According to Those Reporting Adverse Events

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

Gastrooesophageal Reflux Disease
112
Dyspepsia
64
Drug Use For Unknown Indication
35
Product Used For Unknown Indication
25
Abdominal Pain Upper
13
Nausea
13
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Accidental Exposure
7
Gastritis
5
Abdominal Discomfort
5
Prophylaxis
4
Abdominal Pain
3
Duodenal Ulcer
3
Gastric Ph Decreased
2
Gastrooesophagitis
2
Pain
2
Throat Tightness
2
Gastric Disorder
2
Gastroduodenal Ulcer
2
Stomach Discomfort
2
Rash
2
Ulcer
2
Peptic Ulcer
2
Gastric Ulcer
2
Drug Withdrawal Maintenance Therapy
1
Hiatus Hernia
1
Chest Pain
1
Unevaluable Event
1
Premedication
1
Oesophagitis
1
Gastrointestinal Disorder Therapy
1
Antiallergic Therapy
1
Gastroenteritis
1
Gastrointestinal Disorder
1
Vision Blurred
1
Inflammation
1
Gastritis Erosive
1
Ph Body Fluid Decreased
1

Drug Labels

LabelLabelerEffective
Pepcid Ac Maximum StrengthJohnson & Johnson Merck Consumer Pharmaceuticals01-DEC-10
Pepcid Ac Original StrengthJohnson & Johnson Merck Consumer Pharmaceuticals03-MAR-11
Pepcid Ac Maximum StrengthMcNeil Consumer Pharmaceuticals Co.10-OCT-12
Pepcid AcMcNeil Consumer Pharmaceuticals Co.18-OCT-12

Pepcid Ac Case Reports

What Pepcid Ac 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 Ac. 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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