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NEOSPORIN

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Neosporin Adverse Events Reported to the FDA Over Time

How are Neosporin adverse event reports trending over time?

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

Most Common Neosporin Adverse Events Reported to the FDA

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

Off Label Use
83 (3.12%)
Drug Interaction
71 (2.67%)
Hypersensitivity
53 (1.99%)
Drug Hypersensitivity
51 (1.92%)
Blister
49 (1.84%)
International Normalised Ratio Incr...
49 (1.84%)
Rash
48 (1.81%)
Pain
39 (1.47%)
Pruritus
36 (1.35%)
Product Quality Issue
32 (1.2%)
Erythema
31 (1.17%)
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Condition Aggravated
30 (1.13%)
Drug Ineffective
30 (1.13%)
Dyspnoea
29 (1.09%)
Swelling Face
25 (.94%)
Skin Exfoliation
23 (.87%)
Application Site Erythema
22 (.83%)
Dizziness
22 (.83%)
Urticaria
22 (.83%)
Application Site Infection
21 (.79%)
Insomnia
20 (.75%)
Thermal Burn
20 (.75%)
Burning Sensation
19 (.71%)
Application Site Burn
18 (.68%)
Scab
18 (.68%)
Anaphylactic Reaction
17 (.64%)
Incorrect Drug Administration Durat...
17 (.64%)
Lip Blister
17 (.64%)
Lip Swelling
17 (.64%)
Loss Of Consciousness
17 (.64%)
Maternal Drugs Affecting Foetus
17 (.64%)
Weight Decreased
17 (.64%)
Expired Drug Administered
16 (.6%)
Application Site Pruritus
15 (.56%)
Infection
15 (.56%)
Skin Haemorrhage
15 (.56%)
Accidental Exposure
14 (.53%)
Application Site Swelling
14 (.53%)
Emotional Disorder
14 (.53%)
Skin Discolouration
14 (.53%)
Stress
14 (.53%)
Sunburn
14 (.53%)
Swelling
14 (.53%)
Vaginal Haemorrhage
14 (.53%)
Dermatitis
13 (.49%)
Wound
13 (.49%)
Abortion Spontaneous
12 (.45%)
Anaphylactic Shock
12 (.45%)
Anaphylactoid Reaction
12 (.45%)
Application Site Rash
12 (.45%)
Chest Discomfort
12 (.45%)
Haematuria
12 (.45%)
Pain In Extremity
12 (.45%)
Application Site Pain
11 (.41%)
Dermatitis Contact
11 (.41%)
Eye Swelling
11 (.41%)
Headache
11 (.41%)
Incorrect Route Of Drug Administrat...
11 (.41%)
Nausea
11 (.41%)
Feeling Hot
10 (.38%)
Intentional Drug Misuse
10 (.38%)
Lip Exfoliation
10 (.38%)
Nose Deformity
10 (.38%)
Oedema Mouth
10 (.38%)
Oedema Peripheral
10 (.38%)
Oropharyngeal Pain
10 (.38%)
Photosensitivity Reaction
10 (.38%)
Rash Erythematous
10 (.38%)
Scar
10 (.38%)
Ulcer
10 (.38%)
Application Site Irritation
9 (.34%)
Medication Error
9 (.34%)
Nasopharyngitis
9 (.34%)
No Adverse Event
9 (.34%)
Wound Secretion
9 (.34%)
Anxiety
8 (.3%)
Cervical Polyp
8 (.3%)
Chest Pain
8 (.3%)
Contusion
8 (.3%)
Drug Exposure During Pregnancy
8 (.3%)
Epistaxis
8 (.3%)
Feeling Abnormal
8 (.3%)
Gastrointestinal Haemorrhage
8 (.3%)
Haematoma
8 (.3%)
Inflammation
8 (.3%)
Muscle Spasms
8 (.3%)
Speech Disorder
8 (.3%)
Abdominal Pain
7 (.26%)
Application Site Vesicles
7 (.26%)
Bacterial Infection
7 (.26%)
Blood Pressure Decreased
7 (.26%)
Cough
7 (.26%)
Discomfort
7 (.26%)
Gait Disturbance
7 (.26%)
Haemoglobin Decreased
7 (.26%)
Hypotension
7 (.26%)
Impaired Work Ability
7 (.26%)
Lip Pain
7 (.26%)
Pyrexia
7 (.26%)
Rectal Haemorrhage
7 (.26%)
Skin Lesion
7 (.26%)

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

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

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

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

Product Used For Unknown Indication
51
Drug Use For Unknown Indication
35
Oral Candidiasis
27
Wound
22
Rash
21
Laceration
21
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Fungal Infection
18
Chapped Lips
15
Tinea Pedis
15
Scratch
15
Skin Lesion
15
Vaginal Infection
12
Skin Laceration
12
Prophylaxis
12
Pruritus
11
Fabrys Disease
11
Lip Dry
11
Thermal Burn
10
Scar
10
Infection Prophylaxis
9
Eczema
9
Vulvovaginal Pruritus
8
Haemorrhoids
8
Lip Disorder
7
Vulvovaginal Candidiasis
7
Blister
7
Tanning
7
Excoriation
7
Wound Treatment
7
Accidental Exposure
7
Surgery
6
Arthropod Bite
6
Vulvovaginal Mycotic Infection
6
Ear Infection
5
Tinea Infection
5
Oral Fungal Infection
5
Herpes Simplex
5
Hypothyroidism
5
Open Wound
4
Staphylococcal Infection
4
Onychomycosis
4
Erythema
4
Postoperative Care
4
Oesophageal Candidiasis
4
Injury
4
Genital Discharge
4
Skin Irritation
4
Tinea Cruris
4
Nasal Discomfort
3
Pain In Extremity
3
Stomatitis
3

Drug Labels

LabelLabelerEffective
Neosporin Lip Health Overnight Renewal TherapyJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.06-JUN-11
Neosporin Wound CleanserJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.23-JUN-11
NeosporinMonarch Pharmaceuticals, Inc.19-JUL-11
Neosporin OriginalJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.03-AUG-11
Neosporin OriginalJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.08-AUG-11
Neosporin OriginalJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.31-AUG-11
Neosporin G.u.Monarch Pharmaceuticals, Inc.08-SEP-11
Neosporin Eczema Essentials Anti ItchJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.03-OCT-11
Neosporin Essentials Trial PackJohnson & Johnson Consumer Products company, Division of Johnson & Johnson Consumer Companies, Inc.24-OCT-11
Neosporin Eczema Essentialsdaily MoisturizingJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.05-SEP-12
Neosporin Plus Pain Relief Neo To GoJohnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.04-DEC-12

Neosporin Case Reports

What Neosporin 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 Neosporin. 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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