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Tubersol Adverse Events Reported to the FDA Over Time

How are Tubersol adverse event reports trending over time?

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

Most Common Tubersol Adverse Events Reported to the FDA

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

Dyspnoea
128 (3.01%)
Injection Site Erythema
92 (2.16%)
Erythema
85 (2%)
Pruritus
84 (1.98%)
Hypersensitivity
82 (1.93%)
Urticaria
72 (1.69%)
Nausea
69 (1.62%)
Rash
69 (1.62%)
Dizziness
68 (1.6%)
Injection Site Pruritus
64 (1.51%)
Injection Site Reaction
64 (1.51%)
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Headache
52 (1.22%)
Pyrexia
52 (1.22%)
Hypoaesthesia
51 (1.2%)
Asthenia
50 (1.18%)
Paraesthesia
50 (1.18%)
Chest Discomfort
49 (1.15%)
Wheezing
48 (1.13%)
Fatigue
47 (1.11%)
Incorrect Route Of Drug Administrat...
47 (1.11%)
Pain In Extremity
47 (1.11%)
Muscular Weakness
45 (1.06%)
Pain
42 (.99%)
Injection Site Induration
41 (.96%)
Injection Site Pain
39 (.92%)
Oedema Peripheral
39 (.92%)
Arthralgia
38 (.89%)
Pallor
38 (.89%)
Swelling Face
38 (.89%)
Syncope
37 (.87%)
Chest Pain
36 (.85%)
Injection Site Rash
36 (.85%)
Throat Tightness
35 (.82%)
Wrong Drug Administered
35 (.82%)
Loss Of Consciousness
34 (.8%)
Convulsion
33 (.78%)
Anaphylactic Reaction
30 (.71%)
Tremor
30 (.71%)
Cough
29 (.68%)
Hyperhidrosis
29 (.68%)
Swollen Tongue
29 (.68%)
Vomiting
29 (.68%)
Cellulitis
28 (.66%)
Feeling Hot
28 (.66%)
Palpitations
27 (.64%)
Gait Disturbance
26 (.61%)
Injection Site Swelling
25 (.59%)
Pharyngeal Oedema
25 (.59%)
Chills
24 (.56%)
Injection Site Warmth
24 (.56%)
Malaise
24 (.56%)
Lymphadenopathy
23 (.54%)
Rash Macular
22 (.52%)
Presyncope
21 (.49%)
Local Swelling
20 (.47%)
Burning Sensation
19 (.45%)
Pruritus Generalised
19 (.45%)
Rash Erythematous
19 (.45%)
Rash Generalised
19 (.45%)
Hypotension
17 (.4%)
Injection Site Urticaria
17 (.4%)
Blood Pressure Increased
16 (.38%)
Dehydration
16 (.38%)
Feeling Abnormal
16 (.38%)
Guillain-barre Syndrome
16 (.38%)
Injection Site Vesicles
16 (.38%)
Rash Papular
16 (.38%)
Rash Pruritic
16 (.38%)
Tuberculin Test Positive
16 (.38%)
Injection Site Irritation
15 (.35%)
Lethargy
15 (.35%)
Lip Swelling
15 (.35%)
Paraesthesia Oral
15 (.35%)
Sensation Of Heaviness
15 (.35%)
Throat Irritation
15 (.35%)
Blister
14 (.33%)
Flushing
14 (.33%)
Insomnia
14 (.33%)
Balance Disorder
13 (.31%)
Bradycardia
13 (.31%)
Face Oedema
13 (.31%)
Inflammation
13 (.31%)
Medication Error
13 (.31%)
Asthma
12 (.28%)
Drug Exposure During Pregnancy
12 (.28%)
Dysgeusia
12 (.28%)
Respiratory Disorder
12 (.28%)
Dysphagia
11 (.26%)
Eye Rolling
11 (.26%)
Hyperaesthesia
11 (.26%)
Musculoskeletal Stiffness
11 (.26%)
Skin Lesion
11 (.26%)
Skin Warm
11 (.26%)
Angioedema
10 (.24%)
Anxiety
10 (.24%)
Breast Pain
10 (.24%)
Dyskinesia
10 (.24%)
Dysphonia
10 (.24%)
Incorrect Dose Administered
10 (.24%)
Influenza Like Illness
10 (.24%)
Myalgia
10 (.24%)

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

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

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

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

Tuberculin Test
531
Immunisation
45
Drug Use For Unknown Indication
8
Product Used For Unknown Indication
6
Tuberculosis
6
Skin Test
4
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Mycobacterium Tuberculosis Complex ...
4
Vaccinia Virus Infection
2
Medication Error
2
Mass
1
Tuberculosis Prophylaxis
1
Accidental Exposure
1
Prophylaxis
1
Exposure To Communicable Disease
1
Adverse Drug Reaction
1
Necrosis
1
Dermatitis Allergic
1
Inflammation
1
Animal Bite
1
Tuberculosis Test
1
Psoriasis
1

Drug Labels

LabelLabelerEffective
TubersolSanofi Pasteur Inc.20-MAR-13

Tubersol Case Reports

What Tubersol 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 Tubersol. 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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