Drug · FAERS side-effect profile with label screen
Temsirolimus side effects: what 4,502 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Who reports
4,502 reports · 86% serious · 967 with death outcome · 32% 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) 9Reporting / coding artifact 2Lab value / disease marker 4Outcome field, not a reaction 1Not in label — unassessed 13
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. 102 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Mucosal inflammation | 112 | 20.1 16.7–24.1ROR 20.6 · χ² 2,007 / p <1e-300 | 20.0 EB05 17.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · 92% clinician | no trial data cached |
| Disease progression | 480 | 19.0 17.5–20.7ROR 21.2 · χ² 8,195 / p <1e-300 | 18.9 EB05 17.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Pneumonitis | 108 | 18.7 15.5–22.5ROR 19.1 · χ² 1,784 / p <1e-300 | 18.5 EB05 15.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 95% clinician | no trial data cached |
| Neoplasm progression | 110 | 14.6 12.2–17.6ROR 15.0 · χ² 1,382 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Lymphopenia | 37 | 12.3 8.9–16.9ROR 12.4 · χ² 371 / p 5e-83 | 11.9 EB05 8.8 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 · 94% clinician | no trial data cached |
| Hypercholesterolaemia | 25 | 12.2 8.2–18.0ROR 12.3 · χ² 245 / p 1e-55 | 11.5 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 100% clinician | no trial data cached |
| Stomatitis (mouth sores) | 156 | 12.0 10.3–14.0ROR 12.4 · χ² 1,563 / p <1e-300 | 11.9 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 93% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 89 | 11.4 9.3–14.1ROR 11.6 · χ² 837 / p 3e-184 | 11.2 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 · 91% clinician | no trial data cached |
| Interstitial lung disease | 111 | 10.7 8.9–12.9ROR 11.0 · χ² 969 / p 5e-213 | 10.6 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 94% clinician | no trial data cached |
| Proteinuria | 43 | 10.6 7.9–14.3ROR 10.7 · χ² 366 / p 8e-82 | 10.2 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 · 90% clinician | no trial data cached |
| Lung infection | 34 | 10.1 7.2–14.1ROR 10.1 · χ² 268 / p 1e-60 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Blood triglycerides increased | 37 | 9.7 7.1–13.4ROR 9.8 · χ² 281 / p 2e-63 | 9.2 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · 91% clinician | no trial data cached |
| Pleural effusion | 125 | 9.6 8.1–11.4ROR 9.8 · χ² 952 / p 2e-209 | 9.4 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 36 | 9.5 6.9–13.2ROR 9.6 · χ² 265 / p 7e-60 | 8.9 EB05 6.6 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 · 97% clinician | no trial data cached |
| Hyperlipidaemia | 24 | 9.3 6.3–13.9ROR 9.4 · χ² 170 / p 3e-39 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 95% clinician | no trial data cached |
| Hypercalcaemia | 24 | 9.1 6.1–13.5ROR 9.1 · χ² 164 / p 6e-38 | 8.2 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 19 | 8.9 5.7–13.9ROR 8.9 · χ² 125 / p 3e-29 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Febrile neutropenia | 125 | 8.8 7.4–10.5ROR 9.0 · χ² 858 / p 6e-189 | 8.6 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 97% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 81 | 8.2 6.6–10.2ROR 8.4 · χ² 508 / p 1e-112 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 57% (drug 32%) · 96% clinician | no trial data cached |
| Blood bilirubin increased | 46 | 7.9 5.9–10.6ROR 8.0 · χ² 271 / p 3e-61 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 · 93% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 26 | 7.6 5.2–11.2ROR 7.6 · χ² 142 / p 4e-33 | 6.9 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Sudden death | 17 | 7.4 4.6–11.9ROR 7.4 · χ² 88 / p 3e-21 | 6.4 EB05 4.1 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.0 | no trial data cached |
| Blood alkaline phosphatase increased | 39 | 7.3 5.3–10.0ROR 7.4 · χ² 206 / p 5e-47 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 · 92% clinician | no trial data cached |
| Blood creatinine increased | 102 | 7.3 6.0–8.8ROR 7.4 · χ² 546 / p 4e-121 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Renal failure acute | 66 | 7.2 5.6–9.1ROR 7.2 · χ² 343 / p 6e-77 | 6.9 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 92% clinician | no trial data cached |
| Intestinal perforation | 17 | 7.1 4.4–11.3ROR 7.1 · χ² 82 / p 6e-20 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Metastases to lung | 17 | 6.9 4.3–11.0ROR 6.9 · χ² 79 / p 3e-19 | 5.9 EB05 3.9 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 164 | 6.9 5.9–8.0ROR 7.1 · χ² 818 / p 3e-180 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 96% clinician | no trial data cached |
| Small intestinal obstruction | 18 | 6.8 4.3–10.9ROR 6.9 · χ² 84 / p 3e-20 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Ascites | 41 | 6.5 4.8–8.8ROR 6.5 · χ² 185 / p 2e-42 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 95% clinician | no trial data cached |
| Pericardial effusion | 32 | 6.5 4.6–9.2ROR 6.5 · χ² 143 / p 3e-33 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 96% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 26 | 6.4 4.4–9.4ROR 6.5 · χ² 114 / p 8e-27 | 5.8 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 32 | 6.0 4.2–8.5ROR 6.0 · χ² 128 / p 6e-30 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 7% (drug 32%) · 90% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 30 | 6.0 4.2–8.5ROR 6.0 · χ² 119 / p 4e-28 | 5.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 12 | 5.9 3.3–10.3ROR 5.9 · χ² 44 / p 2e-11 | 4.9 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Ileus | 15 | 5.7 3.4–9.4ROR 5.7 · χ² 53 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Dehydration | 162 | 5.7 4.9–6.6ROR 5.8 · χ² 620 / p 3e-137 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 96% clinician | no trial data cached |
| Upper gastrointestinal haemorrhage | 20 | 5.5 3.6–8.6ROR 5.5 · χ² 70 / p 4e-17 | 4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · 100% clinician | no trial data cached |
| Hypoxia (low oxygen) | 41 | 5.5 4.0–7.4ROR 5.5 · χ² 145 / p 1e-33 | 5.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 · 95% clinician | no trial data cached |
| Device related infection | 18 | 5.4 3.4–8.6ROR 5.5 · χ² 61 / p 3e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 | 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 | 480 | 19.0 17.5–20.7ROR 21.2 · χ² 8,195 / p <1e-300 | 18.9 EB05 17.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Death | 286 | 1.5 1.4–1.7ROR 1.6 · χ² 57 / p 2e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Anaemia (low red blood cells) | 188 | 4.6 4.0–5.3ROR 4.7 · χ² 529 / p 2e-117 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Thrombocytopenia (low platelets) | 164 | 6.9 5.9–8.0ROR 7.1 · χ² 818 / p 3e-180 | 6.7 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · 96% clinician | no trial data cached |
| Dehydration | 162 | 5.7 4.9–6.6ROR 5.8 · χ² 620 / p 3e-137 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 96% clinician | no trial data cached |
| Stomatitis (mouth sores) | 156 | 12.0 10.3–14.0ROR 12.4 · χ² 1,563 / p <1e-300 | 11.9 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 93% clinician | no trial data cached |
| Febrile neutropenia | 125 | 8.8 7.4–10.5ROR 9.0 · χ² 858 / p 6e-189 | 8.6 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 97% clinician | no trial data cached |
| Pleural effusion | 125 | 9.6 8.1–11.4ROR 9.8 · χ² 952 / p 2e-209 | 9.4 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 96% clinician | no trial data cached |
| Mucosal inflammation | 112 | 20.1 16.7–24.1ROR 20.6 · χ² 2,007 / p <1e-300 | 20.0 EB05 17.0 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.9 · 92% clinician | no trial data cached |
| Interstitial lung disease | 111 | 10.7 8.9–12.9ROR 11.0 · χ² 969 / p 5e-213 | 10.6 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 94% clinician | no trial data cached |
| Neoplasm progression | 110 | 14.6 12.2–17.6ROR 15.0 · χ² 1,382 / p <1e-300 | 14.5 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Pneumonitis | 108 | 18.7 15.5–22.5ROR 19.1 · χ² 1,784 / p <1e-300 | 18.5 EB05 15.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 106 | 3.6 3.0–4.4ROR 3.7 · χ² 202 / p 4e-46 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 97% clinician | no trial data cached |
| Blood creatinine increased | 102 | 7.3 6.0–8.8ROR 7.4 · χ² 546 / p 4e-121 | 7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Renal failure (kidney failure) | 96 | 3.3 2.7–4.1ROR 3.4 · χ² 156 / p 4e-36 | 3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · 91% 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.
- Neoplasm progression — n=110, PRR 14.6
- Hypercholesterolaemia — n=25, PRR 12.2
- Hypercalcaemia — n=24, PRR 9.1
- Febrile neutropenia — n=125, PRR 8.8
- Hypokalaemia — n=81, PRR 8.2
- Ascites — n=41, PRR 6.5
- Hypocalcaemia — n=26, PRR 6.4
- Osteonecrosis of jaw — n=32, PRR 6.0
- Palmar-plantar erythrodysaesthesia syndrome — n=30, PRR 6.0
- Dehydration — n=162, PRR 5.7
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, thrombocytopenia, dehydration, stomatitis, febrile neutropenia, pleural effusion. 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, fieldpatient.drug.openfda.generic_name.exact, 142 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.