Temsirolimus Injection side effects: what 2,113 FDA adverse event reports show

Temsirolimus Injection · 68 reaction terms · 2,143 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase inhibitor

FDA label, Indications wording

Who reports

2,113 reports · 98% serious · 455 with death outcome · 33% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Temsirolimus injection is indicated for the treatment of advanced renal cell carcinoma. Temsirolimus injection is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma. ( 1 )

FDA label, Indications and Usage

What it is

Temsirolimus, an inhibitor of mTOR, is an antineoplastic agent. Temsirolimus is a white to off-white powder with a molecular formula of C 56 H 87 NO 16 and a molecular weight of 1030.30. It is non-hygroscopic. Temsirolimus is practically insoluble in water and soluble in alcohol.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 11Labeled (related wording) 5Reporting / coding artifact 2Lab value / disease marker 5Outcome field, not a reaction 1Not in label — unassessed 16

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 28 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pneumonitis	69	25.4 20.1–32.0ROR 26.2 · χ² 1,590 / p <1e-300	25.2 EB05 20.6 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3 · 94% clinician	no trial data cached
Mucosal inflammation	66	25.2 19.9–32.0ROR 26.0 · χ² 1,507 / p <1e-300	25.0 EB05 20.3 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 91% clinician	no trial data cached
Hypercholesterolaemia	22	22.9 15.1–34.7ROR 23.1 · χ² 438 / p 2e-97	22.4 EB05 15.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.3 · 100% clinician	no trial data cached
Lymphopenia	27	19.1 13.1–27.8ROR 19.3 · χ² 444 / p 7e-99	18.8 EB05 13.5 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.1 · 92% clinician	no trial data cached
Lymphocyte count decreased	32	18.0 12.7–25.4ROR 18.2 · χ² 496 / p 4e-110	17.7 EB05 13.1 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 13.0 · 97% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	65	17.8 14.0–22.6ROR 18.3 · χ² 1,013 / p 1e-222	17.7 EB05 14.3 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.8 · 94% clinician	no trial data cached
Stomatitis (mouth sores)	106	17.4 14.4–20.9ROR 18.2 · χ² 1,621 / p <1e-300	17.3 EB05 14.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3 · 96% clinician	no trial data cached
Febrile neutropenia	107	16.1 13.3–19.3ROR 16.9 · χ² 1,498 / p <1e-300	16.0 EB05 13.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 97% clinician	no trial data cached
Proteinuria	30	15.8 11.1–22.6ROR 16.0 · χ² 401 / p 1e-89	15.5 EB05 11.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.1 · 93% clinician	no trial data cached
Sudden death	17	15.8 9.8–25.4ROR 15.9 · χ² 221 / p 3e-50	15.1 EB05 9.5 · IC025 +2.7 3/3 methods agree	Outcome field, not a reaction	serious PRR 9.3	no trial data cached
Hypokalaemia (low potassium)	72	15.6 12.4–19.6ROR 16.1 · χ² 969 / p 4e-213	15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · ♀ 58% (drug 33%) · 96% clinician	no trial data cached
Blood bilirubin increased	37	13.6 9.9–18.7ROR 13.8 · χ² 418 / p 3e-93	13.3 EB05 9.9 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 9.2 · 95% clinician	no trial data cached
Disease progression	149	12.6 10.8–14.7ROR 13.4 · χ² 1,580 / p <1e-300	12.5 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 96% clinician	no trial data cached
Hypercalcaemia	15	12.1 7.3–20.0ROR 12.2 · χ² 141 / p 6e-33	10.8 EB05 6.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Upper gastrointestinal haemorrhage	20	11.8 7.6–18.2ROR 11.9 · χ² 186 / p 1e-42	10.9 EB05 7.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.9 · 100% clinician	no trial data cached
Lung infection	18	11.3 7.2–18.0ROR 11.4 · χ² 160 / p 7e-37	10.3 EB05 6.4 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1	no trial data cached
Small intestinal obstruction	14	11.3 6.7–19.1ROR 11.4 · χ² 122 / p 1e-28	9.9 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 6.7	no trial data cached
Posterior reversible encephalopathy syndrome	10	10.4 5.6–19.4ROR 10.5 · χ² 76 / p 1e-18	8.3 EB05 4.4 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.1	no trial data cached
Metastases to lung	12	10.3 5.9–18.2ROR 10.4 · χ² 92 / p 5e-22	8.6 EB05 4.8 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6	no trial data cached
Pleural effusion	62	10.1 7.9–12.9ROR 10.4 · χ² 501 / p 3e-111	9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 95% clinician	no trial data cached
Hyperlipidaemia	12	9.9 5.7–17.5ROR 10.0 · χ² 88 / p 4e-21	8.2 EB05 4.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Device related infection	15	9.7 5.8–16.0ROR 9.7 · χ² 108 / p 1e-25	8.3 EB05 5.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.8	no trial data cached
Hypocalcaemia (low calcium)	18	9.5 6.0–15.0ROR 9.5 · χ² 128 / p 6e-30	8.3 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Thrombocytopenia (low platelets)	101	9.0 7.4–10.9ROR 9.4 · χ² 713 / p 2e-157	8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5 · 96% clinician	no trial data cached
Gastroenteritis	13	8.9 5.2–15.2ROR 8.9 · χ² 83 / p 4e-20	7.3 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Neutrophil count decreased	36	8.8 6.4–12.2ROR 9.0 · χ² 242 / p 6e-55	8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree	Lab value / disease marker	serious PRR 6.0 · 97% clinician	no trial data cached
Osteonecrosis of jaw (jawbone death)	22	8.8 5.8–13.3ROR 8.8 · χ² 144 / p 2e-33	7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Dehydration	115	8.6 7.2–10.2ROR 9.0 · χ² 765 / p 1e-168	8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 96% clinician	no trial data cached
Neoplasm progression	30	8.5 5.9–12.1ROR 8.6 · χ² 191 / p 1e-43	7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.2	no trial data cached
Blood alkaline phosphatase increased	21	8.4 5.5–12.8ROR 8.5 · χ² 129 / p 3e-30	7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree	Lab value / disease marker	serious PRR 5.7 · 95% clinician	no trial data cached
Pericardial effusion	19	8.2 5.2–12.8ROR 8.3 · χ² 113 / p 1e-26	7.2 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.9	no trial data cached
Blood lactate dehydrogenase increased	13	8.1 4.7–13.9ROR 8.1 · χ² 74 / p 4e-18	6.7 EB05 4.0 · IC025 +1.7 3/3 methods agree	Lab value / disease marker	serious PRR 5.1	no trial data cached
Hypoxia (low oxygen)	27	7.6 5.3–11.1ROR 7.7 · χ² 150 / p 1e-34	6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6 · 96% clinician	no trial data cached
Hyponatraemia (low sodium)	42	7.4 5.5–10.0ROR 7.6 · χ² 227 / p 1e-51	7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 93% clinician	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	17	7.2 4.5–11.6ROR 7.3 · χ² 85 / p 2e-20	6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.6	no trial data cached
Renal failure acute	31	7.2 5.0–10.1ROR 7.2 · χ² 158 / p 1e-36	6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Ascites	21	7.1 4.6–10.9ROR 7.1 · χ² 104 / p 1e-24	6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · 95% clinician	no trial data cached
Acute myeloid leukaemia	11	7.0 3.9–12.6ROR 7.0 · χ² 51 / p 5e-13	5.6 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.2	no trial data cached
Interstitial lung disease	34	7.0 5.0–9.8ROR 7.1 · χ² 169 / p 7e-39	6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1 · ♀ 9% (drug 33%) · 94% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	94	6.9 5.7–8.4ROR 7.2 · χ² 470 / p 2e-104	6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · 97% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Disease progression	149	12.6 10.8–14.7ROR 13.4 · χ² 1,580 / p <1e-300	12.5 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 96% clinician	no trial data cached
Anaemia (low red blood cells)	117	6.1 5.1–7.3ROR 6.4 · χ² 497 / p 3e-110	6.0 EB05 5.1 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.9 · 90% clinician	no trial data cached
Dehydration	115	8.6 7.2–10.2ROR 9.0 · χ² 765 / p 1e-168	8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 96% clinician	no trial data cached
Febrile neutropenia	107	16.1 13.3–19.3ROR 16.9 · χ² 1,498 / p <1e-300	16.0 EB05 13.6 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · 97% clinician	no trial data cached
Stomatitis (mouth sores)	106	17.4 14.4–20.9ROR 18.2 · χ² 1,621 / p <1e-300	17.3 EB05 14.7 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3 · 96% clinician	no trial data cached
Thrombocytopenia (low platelets)	101	9.0 7.4–10.9ROR 9.4 · χ² 713 / p 2e-157	8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5 · 96% clinician	no trial data cached
Neutropenia (low neutrophils (infection-fighting cells))	94	6.9 5.7–8.4ROR 7.2 · χ² 470 / p 2e-104	6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.2 · 97% clinician	no trial data cached
Hypokalaemia (low potassium)	72	15.6 12.4–19.6ROR 16.1 · χ² 969 / p 4e-213	15.5 EB05 12.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · ♀ 58% (drug 33%) · 96% clinician	no trial data cached
Pneumonitis	69	25.4 20.1–32.0ROR 26.2 · χ² 1,590 / p <1e-300	25.2 EB05 20.6 · IC025 +4.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.3 · 94% clinician	no trial data cached
Mucosal inflammation	66	25.2 19.9–32.0ROR 26.0 · χ² 1,507 / p <1e-300	25.0 EB05 20.3 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 91% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	65	17.8 14.0–22.6ROR 18.3 · χ² 1,013 / p 1e-222	17.7 EB05 14.3 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.8 · 94% clinician	no trial data cached
Pleural effusion	62	10.1 7.9–12.9ROR 10.4 · χ² 501 / p 3e-111	9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.2 · 95% clinician	no trial data cached
Platelet count decreased	46	4.3 3.2–5.7ROR 4.4 · χ² 113 / p 1e-26	4.1 EB05 3.2 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.1 · 91% clinician	no trial data cached
Epistaxis (nosebleed)	42	5.6 4.1–7.5ROR 5.7 · χ² 153 / p 2e-35	5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.9 · 100% clinician	no trial data cached
Hyponatraemia (low sodium)	42	7.4 5.5–10.0ROR 7.6 · χ² 227 / p 1e-51	7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.5 · 93% clinician	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Hypercholesterolaemia — n=22, PRR 22.9
Febrile neutropenia — n=107, PRR 16.1
Hypokalaemia — n=72, PRR 15.6
Osteonecrosis of jaw — n=22, PRR 8.8
Dehydration — n=115, PRR 8.6
Neoplasm progression — n=30, PRR 8.5
Hyponatraemia — n=42, PRR 7.4
Ascites — n=21, PRR 7.1
Neutropenia — n=94, PRR 6.9

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Temsirolimus?

In FDA FAERS, the most frequently co-reported reaction terms for Temsirolimus are anaemia, dehydration, febrile neutropenia, stomatitis, thrombocytopenia, neutropenia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Temsirolimus have an FDA boxed warning?

No. The FDA label retrieved for Temsirolimus has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Temsirolimus causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 1c207bed-10e3-46f0-ad2c-69d5e5c97736, effective 20200330; matched on openfda.generic_name.exact:"TEMSIROLIMUS")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 68 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.