TEMOCILLIN: 77 Adverse Event Reports & Safety Profile

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Total FAERS Reports

11 (14.3%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Disabilities

First Report: 20120730 · Latest Report: 20230903

What Are the Most Common TEMOCILLIN Side Effects?

#1 Most Reported

Toxicity to various agents

15 reports (19.5%)

#2 Most Reported

Confusional state

13 reports (16.9%)

#3 Most Reported

Liver injury

12 reports (15.6%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Toxicity to various agents	15	19.5%	4	11
Confusional state	13	16.9%	0	11
Liver injury	12	15.6%	4	9
Cholestasis	9	11.7%	0	5
Acute kidney injury	8	10.4%	0	6
Off label use	8	10.4%	2	5
Clostridium difficile infection	7	9.1%	0	7
Drug ineffective	7	9.1%	5	5
Encephalopathy	7	9.1%	0	7
Product use in unapproved indication	7	9.1%	1	3
Hallucination, visual	6	7.8%	0	6
Hyponatraemia	6	7.8%	0	6
Miosis	6	7.8%	0	6
Neurotoxicity	6	7.8%	0	5
Status epilepticus	6	7.8%	0	5
Drug-induced liver injury	5	6.5%	0	5
Hepatic cytolysis	5	6.5%	0	5
Pruritus	5	6.5%	0	5
Pyrexia	5	6.5%	0	4
Septic shock	5	6.5%	2	2

Gender: 21.4% female, 78.6% male. Average age: 65.3 years. Most reports from: FR. View detailed demographics →

Year	Reports	Deaths	Hosp.
2012	1	1	1
2014	2	0	1
2015	2	0	1
2016	1	0	1
2017	1	0	1
2018	3	0	3
2019	12	0	12
2020	11	3	10
2021	1	0	1
2023	8	0	8

Indication	Reports
Urinary tract infection	15
Enterobacter infection	11
Escherichia infection	7
Pneumonia	6
Antibiotic therapy	5
Sepsis	5
Stenotrophomonas infection	5

Official prescribing information from the FDA-approved drug label.