Drug

Temsirolimus Injection

68 flagged reaction(s) · 2,143 total co-reports · max PRR 25.4

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Pneumonitis	69	25.4	26.2	signal
2	Mucosal Inflammation	66	25.2	26.0	signal
3	Hypercholesterolaemia	22	22.9	23.1	signal
4	Lymphopenia	27	19.1	19.3	signal
5	Lymphocyte Count Decreased	32	18.0	18.2	signal
6	Hyperglycaemia	65	17.8	18.3	signal
7	Stomatitis	106	17.4	18.2	signal
8	Febrile Neutropenia	107	16.1	16.9	signal
9	Proteinuria	30	15.8	16.0	signal
10	Sudden Death	17	15.8	15.9	signal
11	Hypokalaemia	72	15.6	16.1	signal
12	Blood Bilirubin Increased	37	13.6	13.8	signal
13	Disease Progression	149	12.6	13.4	signal
14	Hypercalcaemia	15	12.1	12.2	signal
15	Upper Gastrointestinal Haemorrhage	20	11.8	11.9	signal
16	Lung Infection	18	11.3	11.4	signal
17	Small Intestinal Obstruction	14	11.3	11.4	signal
18	Posterior Reversible Encephalopathy Syndrome	10	10.4	10.5	signal
19	Metastases To Lung	12	10.3	10.4	signal
20	Pleural Effusion	62	10.1	10.4	signal
21	Hyperlipidaemia	12	9.9	10.0	signal
22	Device Related Infection	15	9.7	9.7	signal
23	Hypocalcaemia	18	9.5	9.5	signal
24	Thrombocytopenia	101	9.0	9.4	signal
25	Gastroenteritis	13	8.9	8.9	signal
26	Neutrophil Count Decreased	36	8.8	9.0	signal
27	Osteonecrosis Of Jaw	22	8.8	8.8	signal
28	Urosepsis	8	8.6	8.6	signal
29	Dehydration	115	8.6	9.0	signal
30	Neoplasm Progression	30	8.5	8.6	signal
31	Blood Alkaline Phosphatase Increased	21	8.4	8.5	signal
32	Pericardial Effusion	19	8.2	8.3	signal
33	Blood Lactate Dehydrogenase Increased	13	8.1	8.1	signal
34	Intestinal Perforation	9	8.0	8.0	signal
35	Hypoxia	27	7.6	7.7	signal
36	Hyponatraemia	42	7.4	7.6	signal
37	Ileus	9	7.3	7.3	signal
38	Palmar-plantar Erythrodysaesthesia Syndrome	17	7.2	7.3	signal
39	Renal Failure Acute	31	7.2	7.2	signal
40	Ascites	21	7.1	7.1	signal
41	Acute Myeloid Leukaemia	11	7.0	7.0	signal
42	Interstitial Lung Disease	34	7.0	7.1	signal
43	Neutropenia	94	6.9	7.2	signal
44	Aspartate Aminotransferase Increased	36	6.7	6.8	signal
45	Colitis	25	6.6	6.7	signal
46	Peritonitis	13	6.2	6.3	signal
47	Myelodysplastic Syndrome	9	6.2	6.2	signal
48	Anaemia	117	6.1	6.4	signal
49	Renal Tubular Necrosis	6	6.1	6.1	signal
50	Epistaxis	42	5.6	5.7	signal
51	Metastases To Bone	9	5.5	5.5	signal
52	Fistula	6	5.3	5.3	signal
53	Leukopenia	26	5.2	5.2	signal
54	Multi-organ Failure	9	5.1	5.1	signal
55	Melaena	10	4.5	4.5	signal
56	Blood Triglycerides Increased	8	4.5	4.5	signal
57	Osteomyelitis	8	4.4	4.4	signal
58	Platelet Count Decreased	46	4.3	4.4	signal
59	Pneumocystis Jirovecii Pneumonia	4	4.0	4.0	signal
60	Metastases To Central Nervous System	5	3.9	3.9	signal
61	International Normalised Ratio Increased	11	3.8	3.8	signal
62	Malignant Neoplasm Progression	38	3.7	3.8	signal
63	Gastric Haemorrhage	4	3.4	3.4	signal
64	Metastases To Liver	6	3.4	3.4	signal
65	Tuberculosis	4	3.1	3.1	no signal
66	Anorexia	4	3.0	3.0	no signal
67	Neoplasm Malignant	20	3.0	3.0	signal
68	Myelosuppression	9	2.6	2.6	signal