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Actemra Adverse Events Reported to the FDA Over Time

How are Actemra adverse event reports trending over time?

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

Most Common Actemra Adverse Events Reported to the FDA

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

Pneumonia
266 (1.73%)
Arthralgia
196 (1.27%)
Interstitial Lung Disease
176 (1.14%)
Death
159 (1.03%)
Dyspnoea
157 (1.02%)
Diarrhoea
137 (.89%)
Headache
131 (.85%)
Rheumatoid Arthritis
131 (.85%)
Pyrexia
127 (.82%)
Nausea
124 (.81%)
Drug Ineffective
121 (.79%)
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Sepsis
121 (.79%)
Vomiting
114 (.74%)
Oedema Peripheral
110 (.71%)
Pain
110 (.71%)
Anaemia
108 (.7%)
Disseminated Intravascular Coagulat...
108 (.7%)
Malaise
108 (.7%)
Chest Pain
98 (.64%)
Cellulitis
96 (.62%)
Rash
96 (.62%)
Hypertension
95 (.62%)
Myocardial Infarction
93 (.6%)
Dizziness
92 (.6%)
Fall
89 (.58%)
Skin Ulcer
89 (.58%)
Pain In Extremity
88 (.57%)
Bronchitis
86 (.56%)
C-reactive Protein Increased
83 (.54%)
White Blood Cell Count Decreased
82 (.53%)
Abdominal Pain
80 (.52%)
Pruritus
79 (.51%)
Septic Shock
79 (.51%)
Nasopharyngitis
78 (.51%)
Fatigue
71 (.46%)
Arthritis
70 (.45%)
Hepatic Function Abnormal
70 (.45%)
Hypotension
70 (.45%)
Infection
70 (.45%)
Acute Myocardial Infarction
69 (.45%)
Cardiac Failure
68 (.44%)
Joint Swelling
68 (.44%)
Pleural Effusion
68 (.44%)
Urinary Tract Infection
68 (.44%)
Histiocytosis Haematophagic
65 (.42%)
Depression
62 (.4%)
Hypersensitivity
61 (.4%)
Cerebrovascular Accident
58 (.38%)
Infusion Related Reaction
57 (.37%)
Upper Respiratory Tract Inflammatio...
57 (.37%)
Atrial Fibrillation
56 (.36%)
Pulmonary Embolism
56 (.36%)
Deep Vein Thrombosis
54 (.35%)
Thrombocytopenia
54 (.35%)
Cholelithiasis
53 (.34%)
Impaired Healing
50 (.32%)
Platelet Count Decreased
50 (.32%)
Abdominal Pain Upper
48 (.31%)
Influenza
48 (.31%)
Alanine Aminotransferase Increased
47 (.31%)
Pancytopenia
46 (.3%)
Cerebral Infarction
45 (.29%)
Diverticulitis
45 (.29%)
Pancreatitis Acute
45 (.29%)
Asthenia
44 (.29%)
Erythema
44 (.29%)
Pneumocystis Jiroveci Pneumonia
44 (.29%)
Renal Failure
44 (.29%)
Back Pain
42 (.27%)
Hyperhidrosis
42 (.27%)
Cardiac Arrest
41 (.27%)
Cerebral Haemorrhage
40 (.26%)
Dehydration
40 (.26%)
Leukopenia
40 (.26%)
Liver Disorder
40 (.26%)
Herpes Zoster
39 (.25%)
Loss Of Consciousness
39 (.25%)
Swelling
39 (.25%)
Vasculitis
38 (.25%)
Acute Respiratory Distress Syndrome
37 (.24%)
Chills
37 (.24%)
Cough
37 (.24%)
Oropharyngeal Pain
37 (.24%)
Urticaria
37 (.24%)
Angina Pectoris
36 (.23%)
Chest Discomfort
36 (.23%)
Juvenile Arthritis
36 (.23%)
Respiratory Failure
36 (.23%)
Anaphylactic Reaction
35 (.23%)
Hepatitis
35 (.23%)
Pleurisy
35 (.23%)
Weight Increased
35 (.23%)
Asthma
34 (.22%)
Blood Cholesterol Increased
34 (.22%)
Gastrointestinal Haemorrhage
34 (.22%)
Ileus
34 (.22%)
Neutropenia
34 (.22%)
Blood Pressure Decreased
33 (.21%)
Hyperlipidaemia
33 (.21%)
Renal Impairment
33 (.21%)
Subarachnoid Haemorrhage
33 (.21%)

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

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

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

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

Rheumatoid Arthritis
3105
Product Used For Unknown Indication
215
Juvenile Arthritis
164
Castlemans Disease
60
Drug Use For Unknown Indication
21
Stills Disease Adult Onset
19
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Polyarthritis
15
Arthritis
13
Temporal Arteritis
6
Psoriatic Arthropathy
5
Musculoskeletal Pain
5
Amyloidosis
5
Systemic Lupus Erythematosus
5
Vasculitis
4
Wegeners Granulomatosis
4
Polyarteritis Nodosa
4
Seronegative Arthritis
4
Spondyloarthropathy
3
Scleroderma
3
Ankylosing Spondylitis
3
Fibromyalgia
2
Hyper Igd Syndrome
2
Lung Neoplasm Malignant
2
Autoinflammatory Disease
2
Pleural Mesothelioma
2
Weber-christian Disease
2
Rheumatoid Vasculitis
2
Sapho Syndrome
2
Spondylitis
1
Takayasus Arteritis
1
Neuromyelitis Optica
1
Mixed Connective Tissue Disease
1
Myelodysplastic Syndrome
1
Feltys Syndrome
1
Undifferentiated Connective Tissue ...
1
Cryopyrin Associated Periodic Syndr...
1
Fibrosis
1
Gastrointestinal Disorder
1
Antiphospholipid Syndrome
1
Erythema Nodosum
1
Cachexia
1
Polymyalgia Rheumatica
1
Arthropathy
1
Polychondritis
1
Prostatic Specific Antigen
1
Gouty Arthritis
1
Behcets Syndrome
1

Drug Labels

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ActemraGenentech, Inc.24-OCT-12

Actemra Case Reports

What Actemra 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 Actemra. 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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