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SALICYLATE

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Salicylate Adverse Events Reported to the FDA Over Time

How are Salicylate adverse event reports trending over time?

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

Most Common Salicylate Adverse Events Reported to the FDA

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

Completed Suicide
230 (8%)
Intentional Drug Misuse
125 (4.35%)
Incorrect Route Of Drug Administrat...
64 (2.23%)
Death
37 (1.29%)
Vomiting
34 (1.18%)
Feeling Abnormal
31 (1.08%)
Overdose
31 (1.08%)
Cardiac Arrest
30 (1.04%)
Dyspnoea
30 (1.04%)
Nausea
30 (1.04%)
Drug Toxicity
28 (.97%)
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Respiratory Arrest
28 (.97%)
Oral Discomfort
26 (.9%)
Poisoning
26 (.9%)
Erythema
25 (.87%)
Accidental Exposure
24 (.84%)
Anxiety
24 (.84%)
Alcohol Poisoning
23 (.8%)
Glossodynia
23 (.8%)
Malaise
23 (.8%)
Pain
22 (.77%)
Medication Error
20 (.7%)
Cardio-respiratory Arrest
19 (.66%)
Caustic Injury
18 (.63%)
Pruritus
18 (.63%)
Swelling Face
18 (.63%)
Application Site Burn
17 (.59%)
Blister
17 (.59%)
Feeling Drunk
17 (.59%)
Incorrect Dose Administered
17 (.59%)
Hypersensitivity
16 (.56%)
Oral Pain
16 (.56%)
Chest Pain
15 (.52%)
Accidental Drug Intake By Child
14 (.49%)
Condition Aggravated
14 (.49%)
Dizziness
14 (.49%)
Heart Rate Increased
14 (.49%)
Loss Of Consciousness
14 (.49%)
Scar
14 (.49%)
Burning Sensation
13 (.45%)
Swollen Tongue
13 (.45%)
Anorexia
12 (.42%)
Asthenia
12 (.42%)
Diarrhoea
12 (.42%)
Rash
12 (.42%)
Stomatitis
12 (.42%)
Abdominal Pain
11 (.38%)
Alanine Aminotransferase Increased
11 (.38%)
Drug Abuser
11 (.38%)
Gingival Pain
11 (.38%)
Thermal Burn
11 (.38%)
Aspartate Aminotransferase Increase...
10 (.35%)
Blood Alcohol Increased
10 (.35%)
Gingival Bleeding
10 (.35%)
Hypoaesthesia Oral
10 (.35%)
Paraesthesia
10 (.35%)
Tremor
10 (.35%)
Urticaria
10 (.35%)
Vision Blurred
10 (.35%)
Abdominal Pain Upper
9 (.31%)
Anaphylactic Shock
9 (.31%)
Blood Glucose Increased
9 (.31%)
Blood Pressure Increased
9 (.31%)
Cheilitis
9 (.31%)
Headache
9 (.31%)
Liver Disorder
9 (.31%)
Liver Function Test Abnormal
9 (.31%)
Pneumonia Aspiration
9 (.31%)
Skin Exfoliation
9 (.31%)
Tongue Haemorrhage
9 (.31%)
Tongue Ulceration
9 (.31%)
Bacterial Infection
8 (.28%)
Burns Third Degree
8 (.28%)
Convulsion
8 (.28%)
Drug Abuse
8 (.28%)
Drug Hypersensitivity
8 (.28%)
Drug Ineffective
8 (.28%)
Drug Interaction
8 (.28%)
Escherichia Infection
8 (.28%)
Fatigue
8 (.28%)
Gingivitis
8 (.28%)
Hepatic Failure
8 (.28%)
Hyperhidrosis
8 (.28%)
Hypotension
8 (.28%)
Intentional Overdose
8 (.28%)
Pain In Extremity
8 (.28%)
Sepsis
8 (.28%)
Syncope
8 (.28%)
Acidosis
7 (.24%)
Aphthous Stomatitis
7 (.24%)
Asthma
7 (.24%)
Burns Second Degree
7 (.24%)
Cough
7 (.24%)
Dysgeusia
7 (.24%)
Glossitis
7 (.24%)
Hypoaesthesia
7 (.24%)
Multi-organ Failure
7 (.24%)
Oedema Mouth
7 (.24%)
Oxygen Saturation Decreased
7 (.24%)
Pancreatitis
7 (.24%)
Pyrexia
7 (.24%)

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

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

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

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

Dental Disorder Prophylaxis
127
Product Used For Unknown Indication
119
Drug Use For Unknown Indication
115
Pain
22
Back Pain
21
Alcoholism
20
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Accidental Exposure
18
Arthralgia
17
Dental Care
17
Osteoarthritis
16
Alcohol Poisoning
15
Intentional Overdose
15
Breath Odour
14
Feeling Drunk
11
Suicide Attempt
10
Poisoning
10
Alcohol Use
10
Myalgia
9
Halitosis
9
Arthritis
9
Intentional Misuse
9
Rheumatoid Arthritis
8
Completed Suicide
7
Pain In Extremity
7
Ill-defined Disorder
6
Overdose
6
Bursitis
5
Prophylaxis
5
Alcoholic
5
Hyperkeratosis
4
Mouth Ulceration
4
Stomatitis
4
Inflammation
3
Joint Sprain
3
Euphoric Mood
3
Intentional Drug Misuse
3
Dental Plaque
3
Denture Wearer
3
Analgesia
3
Neuropathy Peripheral
3
Periodontal Disease
3
Pharyngolaryngeal Pain
3
Urinary Tract Infection
3
Skin Irritation
2
Hypersensitivity
2
Muscle Spasms
2
Toothache
2
Migraine
2
Injury
2
Neuralgia
2
Pharyngitis
2

Drug Labels

LabelLabelerEffective
Cvs Cold And Hotpain Relieving StickVVF Kansas Services LLC30-OCT-09
Walgreens Cool N Heattherapy Pain Relief StickVVF Kansas Services LLC30-OCT-09
Physostigmine SalicylateAkorn15-NOV-10
Trolamine SalicylatePerrigo New York Inc18-OCT-11
Menthol And Methyl Salicylate H.J. Harkins Company, Inc.01-MAR-12
Choline Magnesium TrisalicylateSilarx Pharmaceuticals, Inc21-DEC-12
Physostigmine SalicylateCardinal Health18-APR-13

Salicylate Case Reports

What Salicylate 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 Salicylate. 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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