ALIMTA: 187 Adverse Event Reports & Safety Profile

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187

Total FAERS Reports

62 (33.2%)

Deaths Reported

103

Hospitalizations

187

As Primary/Secondary Suspect

Life-Threatening

Disabilities

First Report: 2009 · Latest Report: 20140518

What Are the Most Common ALIMTA Side Effects?

#1 Most Reported

Off label use

39 reports (20.9%)

#2 Most Reported

Thrombocytopenia

20 reports (10.7%)

#3 Most Reported

Anaemia

20 reports (10.7%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Off label use	39	20.9%	12	22
Anaemia	20	10.7%	9	17
Thrombocytopenia	20	10.7%	10	14
Renal failure	16	8.6%	9	10
Renal failure acute	16	8.6%	4	14
Pancytopenia	15	8.0%	7	11
Pyrexia	15	8.0%	5	11
Diarrhoea	14	7.5%	6	12
Malignant neoplasm progression	12	6.4%	4	5
Bone marrow failure	11	5.9%	9	6
Dyspnoea	11	5.9%	5	6
General physical health deterioration	11	5.9%	4	9
Neutropenia	11	5.9%	5	9
Vomiting	11	5.9%	4	10
Febrile neutropenia	10	5.4%	7	3
Decreased appetite	8	4.3%	5	7
Asthenia	7	3.7%	3	7
Confusional state	7	3.7%	4	4
Death	7	3.7%	7	3
Hypotension	7	3.7%	3	5

Average age: 64.1 years. Most reports from: FR. View detailed demographics →

Year	Reports	Deaths	Hosp.
2009	1	0	0
2010	4	4	4
2011	3	0	2
2012	11	1	6
2013	55	20	37
2014	55	18	35

Indication	Reports
Non-small cell lung cancer	27
Lung neoplasm malignant	25
Product used for unknown indication	21
Lung adenocarcinoma	20
Lung adenocarcinoma stage iv	17
Pleural mesothelioma malignant	10
Lung adenocarcinoma metastatic	9
Bronchial carcinoma	7
Lung cancer metastatic	6
Mesothelioma	6

Official prescribing information from the FDA-approved drug label.