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CONCENTRATED TYLENOL INFANT DROPS

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Concentrated Tylenol Infant Drops Adverse Events Reported to the FDA Over Time

How are Concentrated Tylenol Infant Drops adverse event reports trending over time?

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

Most Common Concentrated Tylenol Infant Drops Adverse Events Reported to the FDA

What are the most common Concentrated Tylenol Infant Drops adverse events reported to the FDA?

Product Quality Issue
1091 (23.43%)
Pyrexia
302 (6.49%)
Drug Ineffective
275 (5.91%)
Transmission Of An Infectious Agent...
197 (4.23%)
Vomiting
168 (3.61%)
Convulsion
144 (3.09%)
Diarrhoea
98 (2.1%)
Febrile Convulsion
96 (2.06%)
Bacterial Infection
73 (1.57%)
Malaise
71 (1.52%)
Dyspnoea
62 (1.33%)
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Rash
60 (1.29%)
Death
57 (1.22%)
Pneumonia
52 (1.12%)
Dehydration
45 (.97%)
Viral Infection
41 (.88%)
Cough
39 (.84%)
Weight Decreased
36 (.77%)
Ear Infection
34 (.73%)
Hospitalisation
34 (.73%)
Haematochezia
33 (.71%)
Hypersensitivity
30 (.64%)
Lethargy
29 (.62%)
Sudden Infant Death Syndrome
27 (.58%)
Decreased Appetite
24 (.52%)
Product Contamination Physical
24 (.52%)
Infection
23 (.49%)
Product Measured Potency Issue
23 (.49%)
Wheezing
23 (.49%)
Asthma
22 (.47%)
Eating Disorder
22 (.47%)
Insomnia
20 (.43%)
Nasopharyngitis
20 (.43%)
Somnolence
20 (.43%)
Rash Generalised
19 (.41%)
Respiratory Arrest
19 (.41%)
Crying
18 (.39%)
Product Contamination Microbial
18 (.39%)
Renal Disorder
18 (.39%)
Irritability
17 (.37%)
Product Contamination
17 (.37%)
Autism
16 (.34%)
Chills
16 (.34%)
Respiratory Disorder
16 (.34%)
Wrong Drug Administered
16 (.34%)
Coma
14 (.3%)
Inadequate Diet
14 (.3%)
Intentional Drug Misuse
14 (.3%)
Liver Function Test Abnormal
14 (.3%)
Respiratory Distress
14 (.3%)
Urinary Tract Infection
14 (.3%)
Faeces Discoloured
13 (.28%)
Skin Discolouration
13 (.28%)
Accidental Overdose
12 (.26%)
Blister
12 (.26%)
Blood Calcium Increased
12 (.26%)
Body Temperature Increased
12 (.26%)
Condition Aggravated
12 (.26%)
Expired Drug Administered
12 (.26%)
Feeling Abnormal
12 (.26%)
Hypersomnia
12 (.26%)
Rash Macular
12 (.26%)
Abdominal Pain Upper
11 (.24%)
Breath Odour
11 (.24%)
Diarrhoea Haemorrhagic
11 (.24%)
Heart Rate Increased
11 (.24%)
Bronchiolitis
10 (.21%)
Inappropriate Schedule Of Drug Admi...
10 (.21%)
Staphylococcal Infection
10 (.21%)
Abnormal Behaviour
9 (.19%)
Loss Of Consciousness
9 (.19%)
Lower Respiratory Tract Infection B...
9 (.19%)
Osteomyelitis
9 (.19%)
Eczema
8 (.17%)
Meningitis Viral
8 (.17%)
Muscle Spasms
8 (.17%)
Overdose
8 (.17%)
Respiratory Syncytial Virus Infecti...
8 (.17%)
Respiratory Tract Congestion
8 (.17%)
Respiratory Tract Infection Bacteri...
8 (.17%)
Retching
8 (.17%)
Septic Shock
8 (.17%)
Skin Reaction
8 (.17%)
Staphylococcal Skin Infection
8 (.17%)
White Blood Cell Count Increased
8 (.17%)
Adverse Event
7 (.15%)
Anuria
7 (.15%)
Cardiomegaly
7 (.15%)
Catatonia
7 (.15%)
Cyanosis
7 (.15%)
Mucous Stools
7 (.15%)
Psychomotor Hyperactivity
7 (.15%)
Accidental Drug Intake By Child
6 (.13%)
Acute Hepatic Failure
6 (.13%)
Acute Respiratory Distress Syndrome
6 (.13%)
Bacterial Test
6 (.13%)
Bronchial Hyperreactivity
6 (.13%)
Cardiac Arrest
6 (.13%)
Clostridium Difficile Colitis
6 (.13%)
Croup Infectious
6 (.13%)
Depressed Level Of Consciousness
6 (.13%)

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This graph shows the top adverse events submitted to the FDA for Concentrated Tylenol Infant Drops, 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 Concentrated Tylenol Infant Drops 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 Concentrated Tylenol Infant Drops

What are the most common Concentrated Tylenol Infant Drops adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Concentrated Tylenol Infant Drops, 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 Concentrated Tylenol Infant Drops 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 Concentrated Tylenol Infant Drops According to Those Reporting Adverse Events

Why are people taking Concentrated Tylenol Infant Drops, according to those reporting adverse events to the FDA?

Pyrexia
414
Teething
162
Drug Use For Unknown Indication
133
Product Used For Unknown Indication
47
Ear Infection
41
Nasopharyngitis
29
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Immunisation
23
Pain
21
Malaise
15
Irritability
12
Rhinorrhoea
11
Injection
9
Ear Pain
9
Cough
8
Prophylaxis
6
Ill-defined Disorder
5
Viral Infection
5
Antipyresis
5
Drooling
5
Accidental Exposure
4
Sinusitis
4
Analgesic Therapy
3
Labyrinthitis
3
Vomiting
3
Bowel Movement Irregularity
3
Jaundice
3
Respiratory Disorder
2
Procedural Pain
2
Pain Management
2
Herpangina
2
Diarrhoea
2
Oropharyngeal Pain
1
Crying
1
Viral Test Positive
1
Abnormal Behaviour
1
Respiratory Tract Infection
1
Infectious Mononucleosis
1
Vaccination Site Pain
1
Dermatitis Diaper
1
Viral Pharyngitis
1
Nasal Decongestion Therapy
1
Headache
1
Upper Respiratory Tract Infection
1
Influenza
1
Lower Respiratory Tract Infection
1
Rash
1
Discomfort
1
Sinus Headache
1
Nasal Congestion
1
Respiratory Syncytial Virus Infecti...
1
Abdominal Pain
1

Concentrated Tylenol Infant Drops Case Reports

What Concentrated Tylenol Infant Drops 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 Concentrated Tylenol Infant Drops. 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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