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PRILOSEC OTC

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Prilosec Otc Adverse Events Reported to the FDA Over Time

How are Prilosec Otc adverse event reports trending over time?

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

Most Common Prilosec Otc Adverse Events Reported to the FDA

What are the most common Prilosec Otc adverse events reported to the FDA?

Drug Ineffective
822 (7.48%)
Drug Dose Omission
430 (3.91%)
Incorrect Drug Administration Durat...
343 (3.12%)
Gastrooesophageal Reflux Disease
318 (2.89%)
Inappropriate Schedule Of Drug Admi...
270 (2.46%)
Dyspepsia
250 (2.28%)
Malaise
201 (1.83%)
Nausea
184 (1.67%)
Abdominal Pain Upper
175 (1.59%)
Headache
169 (1.54%)
Diarrhoea
165 (1.5%)
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Dizziness
162 (1.47%)
Dyspnoea
153 (1.39%)
Vomiting
152 (1.38%)
Chest Pain
141 (1.28%)
Condition Aggravated
118 (1.07%)
Abdominal Discomfort
112 (1.02%)
Incorrect Dose Administered
91 (.83%)
Pain
91 (.83%)
Intentional Drug Misuse
85 (.77%)
Feeling Abnormal
84 (.76%)
Off Label Use
83 (.76%)
Pain In Extremity
78 (.71%)
Dysphagia
77 (.7%)
Flatulence
72 (.66%)
Injury
72 (.66%)
Throat Irritation
68 (.62%)
Arthralgia
66 (.6%)
Eructation
65 (.59%)
Insomnia
61 (.56%)
Hypersensitivity
59 (.54%)
Back Pain
56 (.51%)
Drug Effect Decreased
56 (.51%)
Constipation
55 (.5%)
Cough
55 (.5%)
Fatigue
55 (.5%)
Weight Decreased
55 (.5%)
Gastric Disorder
54 (.49%)
Anxiety
53 (.48%)
Adverse Event
51 (.46%)
Abdominal Distension
50 (.46%)
Pruritus
49 (.45%)
Rash
48 (.44%)
Asthenia
45 (.41%)
Chest Discomfort
45 (.41%)
Musculoskeletal Pain
45 (.41%)
Dysgeusia
44 (.4%)
Dysphonia
44 (.4%)
Abdominal Pain
41 (.37%)
Palpitations
40 (.36%)
Depression
39 (.35%)
Wrong Technique In Drug Usage Proce...
39 (.35%)
Aphagia
37 (.34%)
Hiatus Hernia
36 (.33%)
Urticaria
36 (.33%)
Burning Sensation
35 (.32%)
Labelled Drug-drug Interaction Medi...
35 (.32%)
Muscle Spasms
35 (.32%)
Somnolence
34 (.31%)
Paraesthesia
33 (.3%)
Fall
32 (.29%)
Hypertension
32 (.29%)
Dry Mouth
31 (.28%)
Myalgia
30 (.27%)
Neck Pain
30 (.27%)
Oedema Peripheral
30 (.27%)
Pneumonia
29 (.26%)
Blood Pressure Increased
28 (.25%)
Vision Blurred
28 (.25%)
Wrong Drug Administered
28 (.25%)
Faeces Discoloured
27 (.25%)
Regurgitation
27 (.25%)
Discomfort
26 (.24%)
Cerebrovascular Accident
25 (.23%)
Decreased Appetite
25 (.23%)
Gastritis
25 (.23%)
Myocardial Infarction
25 (.23%)
Drug Administration Error
24 (.22%)
Heart Rate Increased
24 (.22%)
Hyperhidrosis
24 (.22%)
Migraine
24 (.22%)
Oropharyngeal Pain
24 (.22%)
Haemorrhage
23 (.21%)
Pruritus Generalised
23 (.21%)
Hyperchlorhydria
22 (.2%)
Laceration
22 (.2%)
Lip Swelling
22 (.2%)
Throat Tightness
22 (.2%)
Visual Impairment
22 (.2%)
Blood Glucose Increased
21 (.19%)
Erythema
21 (.19%)
Osteoporosis
21 (.19%)
Drug Hypersensitivity
20 (.18%)
Drug Interaction
20 (.18%)
Foot Fracture
20 (.18%)
Hypoaesthesia
20 (.18%)
Pharyngeal Oedema
20 (.18%)
Road Traffic Accident
20 (.18%)
Sensation Of Foreign Body
20 (.18%)
Anaemia
19 (.17%)
Asthma
19 (.17%)

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

What are the most common Prilosec Otc adverse events reported to the FDA?

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

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

Gastrooesophageal Reflux Disease
456
Dyspepsia
370
Product Used For Unknown Indication
34
Gastric Disorder
26
Ulcer
22
Hiatus Hernia
18
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Drug Use For Unknown Indication
15
Abdominal Pain Upper
15
Gastritis
13
Abdominal Discomfort
13
Flatulence
12
Hyperchlorhydria
10
Prophylaxis
10
Barretts Oesophagus
10
Reflux Oesophagitis
9
Nausea
8
Gastric Ulcer
7
Hernia
6
Eructation
6
Chest Pain
6
Prophylaxis Against Gastrointestina...
6
Cough
5
Gastrointestinal Disorder
4
Oesophageal Disorder
4
Chest Discomfort
4
Irritable Bowel Syndrome
4
Gastrointestinal Ulcer
4
Oesophagitis
4
Helicobacter Infection
4
Erosive Oesophagitis
4
Oesophageal Ulcer
4
Oesophageal Stenosis
3
Regurgitation
3
Oropharyngeal Pain
2
Vomiting
2
Costochondritis
2
Oropharyngeal Spasm
2
Gastrooesophageal Reflux Prophylaxi...
2
Decreased Appetite
2
Diarrhoea
2
Peptic Ulcer
2
Diverticulitis
2
Oesophageal Spasm
1
Hypertension
1
Crohns Disease
1
Scab
1
Throat Irritation
1
Pain In Extremity
1
Vertigo
1
Suicide Attempt
1
Pharyngeal Disorder
1

Drug Labels

LabelLabelerEffective
Prilosec OtcPhysicians Total Care, Inc.20-JUN-11
Prilosec OtcProcter & Gamble Manufacturing Company20-JUN-11
Prilosec Otc Procter & Gamble Manufacturing Company10-SEP-12

Prilosec Otc Case Reports

What Prilosec Otc 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 Prilosec Otc. 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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