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Actimmune Adverse Events Reported to the FDA Over Time

How are Actimmune adverse event reports trending over time?

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

Most Common Actimmune Adverse Events Reported to the FDA

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

Death
27 (3.71%)
Disease Progression
24 (3.3%)
Pneumonia
19 (2.61%)
Interstitial Lung Disease
18 (2.48%)
Pyrexia
17 (2.34%)
Dyspnoea
14 (1.93%)
Influenza Like Illness
13 (1.79%)
Chills
11 (1.51%)
Condition Aggravated
9 (1.24%)
Respiratory Failure
9 (1.24%)
Anaemia
8 (1.1%)
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Weight Decreased
8 (1.1%)
Idiopathic Pulmonary Fibrosis
7 (.96%)
Nausea
7 (.96%)
Asthenia
6 (.83%)
Back Pain
6 (.83%)
Cough
6 (.83%)
Fatigue
6 (.83%)
General Physical Health Deteriorati...
6 (.83%)
Oxygen Saturation Decreased
6 (.83%)
Renal Failure
6 (.83%)
Cellulitis
5 (.69%)
Headache
5 (.69%)
Hypoxia
5 (.69%)
Pleural Effusion
5 (.69%)
Pulmonary Embolism
5 (.69%)
Pulmonary Fibrosis
5 (.69%)
Small Intestinal Obstruction
5 (.69%)
Thrombocytopenia
5 (.69%)
Tremor
5 (.69%)
Vomiting
5 (.69%)
Abdominal Pain
4 (.55%)
Acute Respiratory Distress Syndrome
4 (.55%)
Arthralgia
4 (.55%)
Chest Pain
4 (.55%)
Deep Vein Thrombosis
4 (.55%)
Dehydration
4 (.55%)
Diarrhoea
4 (.55%)
Drug Ineffective
4 (.55%)
Dyspnoea Exertional
4 (.55%)
Heart Rate Increased
4 (.55%)
Hypersensitivity
4 (.55%)
Hypotension
4 (.55%)
Infection
4 (.55%)
Malaise
4 (.55%)
No Therapeutic Response
4 (.55%)
Restlessness
4 (.55%)
Acute Respiratory Failure
3 (.41%)
Atrial Fibrillation
3 (.41%)
Bladder Cancer
3 (.41%)
Cardiac Failure
3 (.41%)
Cerebrovascular Accident
3 (.41%)
Colonic Stenosis
3 (.41%)
Device Failure
3 (.41%)
Fall
3 (.41%)
Gastroenteritis
3 (.41%)
Hiatus Hernia
3 (.41%)
Leukopenia
3 (.41%)
Liver Abscess
3 (.41%)
Loss Of Consciousness
3 (.41%)
Lymphoma
3 (.41%)
Medication Error
3 (.41%)
Metastases To Lymph Nodes
3 (.41%)
Myalgia
3 (.41%)
Myositis
3 (.41%)
Neutropenia
3 (.41%)
Neutropenic Colitis
3 (.41%)
Pain
3 (.41%)
Pleural Fibrosis
3 (.41%)
Pneumothorax
3 (.41%)
Renal Failure Acute
3 (.41%)
Tachycardia
3 (.41%)
Tachypnoea
3 (.41%)
Therapeutic Response Decreased
3 (.41%)
Treatment Noncompliance
3 (.41%)
Upper Respiratory Tract Infection
3 (.41%)
White Blood Cell Count Decreased
3 (.41%)
Anorexia
2 (.28%)
Anxiety
2 (.28%)
Aortic Aneurysm
2 (.28%)
Benign Duodenal Neoplasm
2 (.28%)
Bladder Obstruction
2 (.28%)
Blood Glucose Increased
2 (.28%)
Body Temperature Increased
2 (.28%)
Bronchitis
2 (.28%)
Cardiac Arrest
2 (.28%)
Cardiac Failure Congestive
2 (.28%)
Cardio-respiratory Arrest
2 (.28%)
Cardiomegaly
2 (.28%)
Catheter Related Infection
2 (.28%)
Central Line Infection
2 (.28%)
Completed Suicide
2 (.28%)
Convulsion
2 (.28%)
Decreased Appetite
2 (.28%)
Disease Recurrence
2 (.28%)
Dizziness
2 (.28%)
Feeling Cold
2 (.28%)
Gait Disturbance
2 (.28%)
Gastritis
2 (.28%)
Haematemesis
2 (.28%)
Haemoglobin Decreased
2 (.28%)

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

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

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

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

Interstitial Lung Disease
112
Idiopathic Pulmonary Fibrosis
58
Hepatitis C
30
Chronic Granulomatous Disease
20
Hepatic Cirrhosis
19
Hepatic Fibrosis
18
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Ovarian Cancer
11
Pulmonary Fibrosis
9
Alveolitis Fibrosing
7
Metastases To Bone
6
Hepatitis C Virus
5
Neoplasm Malignant
5
Renal Cell Carcinoma Stage Unspecif...
4
Lung Disorder
4
Neutrophil Function Disorder
3
Retinoblastoma
3
Asthma
3
Metastatic Renal Cell Carcinoma
2
Adenocarcinoma Pancreas
2
Osteopetrosis
2
Fungal Infection
2
Jc Virus Infection
1
Cystic Fibrosis
1
Endocarditis Q Fever
1
Lung Infection
1
Non-hodgkins Lymphoma
1
Ovarian Cancer Recurrent
1
Pneumonitis
1
Progressive Multifocal Leukoencepha...
1
Mycobacterium Avium Complex Infecti...
1
Zygomycosis
1
Asbestosis
1
Glioma
1
Systemic Sclerosis
1
Ill-defined Disorder
1
Pulmonary Hypertension
1
Mycobacterium Abscessus Infection
1
Inflammation
1
Pyogenic Granuloma
1
Skin Papilloma
1
Bovine Tuberculosis
1
Mycobacterial Infection
1
Rheumatoid Arthritis
1
Tuberculosis
1

Drug Labels

LabelLabelerEffective
ActimmuneInterMune, Inc.03-JAN-13

Actimmune Case Reports

What Actimmune 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 Actimmune. 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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