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Rolaids Adverse Events Reported to the FDA Over Time

How are Rolaids adverse event reports trending over time?

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

Most Common Rolaids Adverse Events Reported to the FDA

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

Product Quality Issue
197 (9.16%)
Diarrhoea
129 (6%)
Vomiting
118 (5.49%)
Nausea
96 (4.47%)
Abdominal Pain Upper
94 (4.37%)
Malaise
73 (3.4%)
Off Label Use
39 (1.81%)
Product Odour Abnormal
31 (1.44%)
Weight Decreased
31 (1.44%)
Condition Aggravated
30 (1.4%)
Expired Drug Administered
29 (1.35%)
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Headache
29 (1.35%)
Dyspepsia
27 (1.26%)
Dehydration
25 (1.16%)
Incorrect Drug Administration Durat...
25 (1.16%)
Abdominal Distension
24 (1.12%)
Chest Pain
24 (1.12%)
Pain
23 (1.07%)
Abdominal Pain
20 (.93%)
Impaired Work Ability
20 (.93%)
Abdominal Discomfort
19 (.88%)
Overdose
19 (.88%)
Gastric Disorder
18 (.84%)
Tooth Fracture
18 (.84%)
Decreased Appetite
17 (.79%)
Haematochezia
17 (.79%)
Fatigue
16 (.74%)
Constipation
15 (.7%)
Drug Exposure During Pregnancy
15 (.7%)
Product Taste Abnormal
15 (.7%)
Insomnia
14 (.65%)
Blood Pressure Increased
13 (.6%)
Gastrointestinal Disorder
13 (.6%)
Myocardial Infarction
13 (.6%)
Tooth Disorder
13 (.6%)
Dizziness
12 (.56%)
Gallbladder Disorder
12 (.56%)
Gastrointestinal Infection
12 (.56%)
Gastrointestinal Inflammation
12 (.56%)
Gastrooesophageal Reflux Disease
12 (.56%)
Drug Ineffective
11 (.51%)
Hypersensitivity
10 (.47%)
Nephrolithiasis
10 (.47%)
Urticaria
10 (.47%)
Asthenia
9 (.42%)
Chills
9 (.42%)
Dysgeusia
9 (.42%)
Loss Of Consciousness
9 (.42%)
Loss Of Employment
9 (.42%)
Renal Failure
8 (.37%)
Throat Irritation
8 (.37%)
Activities Of Daily Living Impaired
7 (.33%)
Blood Calcium Increased
7 (.33%)
Blood Urine Present
7 (.33%)
Colitis Ulcerative
7 (.33%)
Cough
7 (.33%)
Hyperhidrosis
7 (.33%)
Product Contamination Physical
7 (.33%)
Pyrexia
7 (.33%)
Transmission Of An Infectious Agent...
7 (.33%)
Death
6 (.28%)
Diverticulitis
6 (.28%)
Dyspnoea
6 (.28%)
Fall
6 (.28%)
Oesophageal Infection
6 (.28%)
Renal Pain
6 (.28%)
Swelling
6 (.28%)
Tremor
6 (.28%)
Abortion Spontaneous
5 (.23%)
Balance Disorder
5 (.23%)
Blood Creatinine Increased
5 (.23%)
Confusional State
5 (.23%)
Dyskinesia
5 (.23%)
Flatulence
5 (.23%)
Haemorrhage
5 (.23%)
Inflammation
5 (.23%)
Influenza Like Illness
5 (.23%)
Jaw Disorder
5 (.23%)
Memory Impairment
5 (.23%)
Oesophageal Disorder
5 (.23%)
Pain In Jaw
5 (.23%)
Parosmia
5 (.23%)
Poor Quality Drug Administered
5 (.23%)
Surgery
5 (.23%)
Toothache
5 (.23%)
Abasia
4 (.19%)
Accidental Drug Intake By Child
4 (.19%)
Blood Glucose Increased
4 (.19%)
Blood Sodium Decreased
4 (.19%)
Burning Sensation
4 (.19%)
Ear Pain
4 (.19%)
Eye Swelling
4 (.19%)
Feeling Abnormal
4 (.19%)
Gastric Ulcer
4 (.19%)
Gastrointestinal Oedema
4 (.19%)
Gastrointestinal Ulcer
4 (.19%)
Haematemesis
4 (.19%)
Infection
4 (.19%)
Intestinal Haemorrhage
4 (.19%)
Irritable Bowel Syndrome
4 (.19%)
Neck Pain
4 (.19%)

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

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

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

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

Dyspepsia
233
Drug Use For Unknown Indication
57
Gastrooesophageal Reflux Disease
54
Product Used For Unknown Indication
38
Abdominal Discomfort
34
Flatulence
21
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Abdominal Pain Upper
13
Nausea
10
Hyperchlorhydria
7
Antacid Therapy
6
Mineral Supplementation
6
Abdominal Distension
4
Stomach Discomfort
3
Accidental Exposure
3
Drug Exposure During Pregnancy
3
Gastritis
2
Gastric Ulcer
2
Stress
2
Gastric Disorder
2
Diarrhoea
2
Throat Irritation
2
Gastrointestinal Disorder
2
Ulcer
2
Arthralgia
1
Hiatus Hernia
1
Nephrolithiasis
1
Colitis Ulcerative
1
Prophylaxis
1
Hernia
1
Unevaluable Event
1
Chest Pain
1
Coeliac Disease
1
Ill-defined Disorder
1
Reflux Oesophagitis
1
Vomiting
1
Glossodynia
1
Drug Dependence
1
Blood Calcium Abnormal
1
Boredom
1
Muscle Spasms
1
Abdominal Pain
1
Gastric Ph Decreased
1
Angina Pectoris
1
Pain
1

Drug Labels

LabelLabelerEffective
Rolaids Multi-symptomMcNeil Consumer Healthcare Div. McNeil-PPC, Inc10-MAY-11

Rolaids Case Reports

What Rolaids 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 Rolaids. 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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