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Temsirolimus Side Effects

Common Temsirolimus Side Effects


The most commonly reported Temsirolimus side effects (click to view or check a box to report):

Disease Progression (85)
Pneumonia (67)
Dyspnoea (67)
Diarrhoea (62)
Pyrexia (61)
Dehydration (59)
Anaemia (52)
Death (47)
Vomiting (45)
Fatigue (43)
Renal Cell Carcinoma (41)
Febrile Neutropenia (40)
Nausea (40)
Interstitial Lung Disease (40)
Pleural Effusion (37)
Sepsis (35)
Deep Vein Thrombosis (32)
Hyperglycaemia (32)
Pneumonitis (30)
Haemoglobin Decreased (28)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Temsirolimus Side Effects Reported to FDA

The following Temsirolimus reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Temsirolimus on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Disease Progression, Metastatic Renal Cell Carcinoma
This is a report of a 76-year-old male patient (weight: NA) from JP, suffering from the following symptoms/conditions: metastatic renal cell carcinoma, who was treated with Temsirolimus (dosage: 25 Mg, Weekly, start time: Jan 05, 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Disease Progression
  • Metastatic Renal Cell Carcinoma
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in disease progression side effect.

Diabetes Mellitus, Transaminases Increased, Dyslipidaemia
This report suggests a potential Temsirolimus Diabetes Mellitus, Transaminases Increased, Dyslipidaemia side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: renal cell carcinoma and used Temsirolimus (dosage: 25 Mg, Weekly) starting NS. Soon after starting Temsirolimus the patient began experiencing various side effects, including:
  • Diabetes Mellitus
  • Transaminases Increased
  • Dyslipidaemia
Drugs used concurrently: NA. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as diabetes mellitus, may still occur.

Osteonecrosis Of Jaw
This Osteonecrosis Of Jaw problem was reported by a health professional from BR. A 61-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: renal cell carcinoma. On NS this consumer started treatment with Temsirolimus (dosage: 25 Mg, Weekly). The following drugs were being taken at the same time:
  • Bevacizumab (10 Mg/kg, Every 2 Weeks)
  • Captopril (25 Mg, 2x/day)
  • Hydrochlorothiazide (25 Mg, 1x/day)
When commencing Temsirolimus, the patient experienced the following unwanted symptoms/side effects:
  • Osteonecrosis Of Jaw
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as osteonecrosis of jaw, may become evident only after a product is in use by the general population.

Mycobacterial Infection, Hyperglycaemia
This is a report of a 66-year-old male patient (weight: NA) from CZ. The patient developed the following symptoms/conditions: metastatic renal cell carcinoma and was treated with Temsirolimus (dosage: 25 Mg, Weekly) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Mycobacterial Infection
  • Hyperglycaemia
This opens a possibility that Temsirolimus treatment could cause the above reactions, including mycobacterial infection, and some male subjects may be more susceptible.


Erythema, Dyspnoea
A 67-year-old female patient (weight: NA) from FR with the following symptoms/conditions: non-small cell lung cancer started Temsirolimus treatment (dosage: 8 Mg, Weekly) on 201109. Soon after starting Temsirolimus treatment, the subject experienced various side effects, including:
  • Erythema
  • Dyspnoea
Concurrently used drugs:
  • Neratinib (240 Mg, Daily)
  • Neratinib (160 Mg, Daily)
  • Loperamide (Unk)
  • Tiorfan (Unk)
  • Ivabradine Hydrochloride (Unk)
  • Paracetamol With Codeine (Unk)
  • Fraxodi (Unk)
This finding indicates that some female patients could be more vulnerable to Temsirolimus.

Dehydration
A 71-year-old female patient from US (weight: NA) experienced symptoms, such as: non-small cell lung cancer and was treated with Temsirolimus(dosage: 8 Mg, Weekly). The treatment was initiated on Jul 12, 2013. After that a consumer reported the following side effect(s):
  • Dehydration
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Temsirolimus efficacy: NA.The patient was hospitalized.

Hyponatraemia, Hypokalaemia, Nausea, Diarrhoea
In this report, Temsirolimus was administered for the following condition: non-small cell lung cancer.A 38-year-old female consumer from US (weight: NA) started Temsirolimus treatment (dosage: 8 Mg, Weekly) on Sep 24, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Hyponatraemia
  • Hypokalaemia
  • Nausea
  • Diarrhoea
A possible interaction with other drugs could have contributed to this reaction:
  • Neratinib (240 Mg, Daily)
  • Docusate (Unk)
  • Senna (Unk)
  • Miralax (Unk)
  • Lorazepam (Unk)
  • Nasal Saline (Unk)
  • Benzonatate (Unk)
  • Guaifenesin W/dextromethorphan (Unk)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Temsirolimus treatment could be related to the listed above side effect(s).

Bronchopneumonia
This is a report of the following Temsirolimus side effect(s):
  • Bronchopneumonia
A 71-year-old male patient from ES (weight: NA) presented with the following condition: renal cell carcinoma,prostate cancer and received a treatment with Temsirolimus (dosage: 10 Mg/ml, Weekly) starting: Aug 19, 2010.The following concurrently used drugs could have generated interactions:
  • Zoladex (Unk)
  • Casodex (Unk)
  • Carvedilol (Unk)
  • Captopril (Unk)
  • Lovastatin (Unk)
The patient was hospitalized.This report suggests that a Temsirolimus treatment could be associated with the listed above side effect(s).

Disease Progression, Renal Cell Carcinoma
This Temsirolimus report was submitted by a 62-year-old female consumer from JP (weight: NA). The patient was diagnosed with: renal cell carcinoma,prophylaxis,cancer pain,constipation and Temsirolimus was administered (dosage: 25 Mg, Weekly) starting: Feb 14, 2011. The consumer developed a set of symptoms:
  • Disease Progression
  • Renal Cell Carcinoma
Other drugs used simultaneously:
  • Polaramine (2 Mg, Weekly)
  • Fentos (4 Mg, 1x/day)
  • Maglax (660 Mg, 3x/day)
  • Lansoprazole Od (30 Mg, 1x/day)
  • Gasmotin (5 Mg, 3x/day)
  • Loxoprofen Sodium (1 Df, 3x/day)
  • Rebamipide (1 Df, 3x/day)
  • Depas (0.5 Mg, 1x/day)
Those unexpected symptoms could be linked to a Temsirolimus treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Acute Respiratory Distress Syndrome, Pneumonia Staphylococcal
This is a report of a possible correlation between Temsirolimus use and the following symptoms/side effect(s):
  • Acute Respiratory Distress Syndrome
  • Pneumonia Staphylococcal
which could contribute to an assessment of Temsirolimus risk profile.A 75-year-old male consumer from JP (weight: NA) was suffering from renal cell carcinoma,prophylaxis and was treated with Temsirolimus (dosage: 25 Mg, Weekly) starting Dec 15, 2011.Other concurrent medications:
  • Restamin (60 Mg, 1x/day (on Temsirolimus Administration Day))
  • Fentos (1 Mg, 2x/day)
  • Opso (5 Mg, As Needed)
  • Loxonin (120 Mg, 2x/day)
  • Osteluc (400 Mg, 2x/day)
  • Antobron (15 Mg, 3x/day)
  • Eticalm (1.0 Mg, 1x/day)
  • Amoban (7.5 Mg, 1x/day)
The patient was hospitalized.

Back Pain, Pancreatitis
A 57-year-old female patient from US (weight: NA) presented with the following symptoms: renal cell carcinoma and after a treatment with Temsirolimus (dosage: NA) experienced the following side effect(s):
  • Back Pain
  • Pancreatitis
The treatment was started on 201301. Temsirolimus was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Temsirolimus consumers.

Vena Cava Thrombosis, Jugular Vein Thrombosis
In this report, a 64-year-old male patient from DE (weight: NA) was affected by a possible Temsirolimus side effect.The patient was diagnosed with NA. After a treatment with Temsirolimus (dosage: 25 Mg, Cyclic (on Day 1 And Day 8), start date: Sep 13, 2013), the patient experienced the following side effect(s):
  • Vena Cava Thrombosis
  • Jugular Vein Thrombosis
The following simultaneously used drugs could have led to this reaction:
  • Cisplatin (170 Mg, Unk)
  • Rituximab (637.5 Mg, Unk)
  • Dexamethasone (40 Mg, Unk)
  • Cytarabine (6900 Mg, 2x/day)
  • Metformin (1000 Mg, Daily)
  • Januvia (50 Mg, Unk)
  • Simvastatin (20 Mg, Daily)
  • Pantozol (40 Mg, Daily)
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Temsirolimus treatment.

Opportunistic Infection, Muscle Haemorrhage
This is a report of a 62-year-old male patient from GR (weight: NA), who used Temsirolimus (dosage: 25 Mg, Weekly) for a treatment of pancreatic carcinoma metastatic. After starting a treatment on Aug 01, 2013, the patient experienced the following side effect(s):
  • Opportunistic Infection
  • Muscle Haemorrhage
The following drugs could possibly have interacted with the Temsirolimus treatment
  • Gemzar (2000 Mg (1000mg/m2), Cyclic (every Two Weeks))
  • Norvasc (5 Mg, 1x/day)
  • Zofron
  • Zantac
  • Fenistil
  • Dexamethasone
  • Sotalol (40 Mg, 2x/day)
  • Salospir (100 Mg, 1x/day)
The patient was hospitalized.Taken together, these observations suggest that a Temsirolimus treatment could be related to side effect(s), such as Opportunistic Infection, Muscle Haemorrhage.

Pneumocystis Jirovecii Infection
This pneumocystis jirovecii infection side effect was reported by a physician from GR. A 72-year-old male patient (weight:NA) experienced the following symptoms/conditions: pancreatic carcinoma metastatic. The patient was prescribed Temsirolimus (dosage: 25 Mg, Weekly), which was started on Jul 11, 2013. Concurrently used drugs:
  • Gemzar (1850 Mg, Cyclic (every Two Weeks))
  • Zofron
  • Zantac
  • Fenistil
  • Dexamethasone
  • Sotalol (160 Mg, 1/2x2)
  • Pantoprazole (40 Mg, 1x/day)
  • Pantoprazole
When starting to take Temsirolimus the consumer reported the following symptoms:
  • Pneumocystis Jirovecii Infection
The patient was hospitalized. These side effects may potentially be related to Temsirolimus.

Neutropenic Sepsis
This is a Temsirolimus side effect report of a 60-year-old male patient (weight:NA) from GB, suffering from the following symptoms/conditions: NA, who was treated with Temsirolimus (dosage:10 Mg, Unk, start time: Jun 13, 2013), combined with:
  • Gemcitabine Hydrochloride (1700 Mg, 2x/day)
  • Cisplatin (154 Mg, Unk)
, and developed a serious reaction and a neutropenic sepsis side effect. The patient presented with:
  • Neutropenic Sepsis
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Temsirolimus treatment in male patients suffering from NA, resulting in neutropenic sepsis.

Respiratory Failure, Sepsis, Renal Failure Acute
This report suggests a potential Temsirolimus respiratory failure side effect(s) that can have serious consequences. A 68-year-old male patient from DE (weight:NA) was diagnosed with the following health condition(s): NA and used Temsirolimus (dosage: 50 Mg, Unk) starting Apr 26, 2013. Soon after starting Temsirolimus the patient began experiencing various side effects, including:
  • Respiratory Failure
  • Sepsis
  • Renal Failure Acute
Drugs used concurrently:
  • Bendamustine (179 Mg, Unk)
  • Rituximab (745 Mg, Unk)
The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as respiratory failure, may still occur.

Renal Tubular Necrosis
This renal tubular necrosis problem was reported by a health professional from FR. A 73-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): mantle cell lymphoma.On 201008 a consumer started treatment with Temsirolimus (dosage: Unk). The following drugs/medications were being taken at the same time:
  • Rituximab (Unk)
  • Dexamethasone (Unk)
  • Oxaliplatin (Unk)
  • Citarabin (Unk)
When commencing Temsirolimus, the patient experienced the following unwanted symptoms /side effects:
  • Renal Tubular Necrosis
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as renal tubular necrosis, may become evident only after a product is in use by the general population.

Cardiac Failure
This is a Temsirolimus side effect report of a 72-year-old male patient (weight: NA) from DE. The patient developed the following symptoms/conditions: acute myeloid leukaemia and was treated with Temsirolimus (dosage: 12.5 Mg, Cyclic (induction I)) starting Sep 17, 2013. Concurrently used drugs:
  • Daunorubicin Hcl (116.4 Mg, Daily)
  • Cytarabine (194 Mg, Daily)
  • Aciclovir (400 Mg, 3x/day)
  • Hydrochlorothiazide/irbesartan Hydrochloride (12.5mg/150mg, Daily)
  • Trimethoprim Comp.-ratiopharm (80 Mg Trimethoprim /10 Mg Sulfamethoxazole On Monday And Thursday)
  • Tamsulosin (0.4 Mg, Daily)
  • Torasemide (10 Mg, Daily)
  • Colistin (Unk)
Soon after that, the consumer experienced the following of symptoms:
  • Cardiac Failure
This opens a possibility that Temsirolimus could cause cardiac failure and that some male patients may be more susceptible.

Febrile Neutropenia
A 60-year-old male patient (weight: NA) from GB with the following symptoms: transitional cell carcinoma started Temsirolimus treatment (dosage: 10 Mg, Unk) on Jul 18, 2013. Soon after starting Temsirolimus treatment, the consumer experienced several side effects, including:
  • Febrile Neutropenia
. Concurrently used drugs:
  • Cisplatin (154 Mg, Unk)
  • Gemcitabine Hydrochloride (2200 Mg, Unk)
  • Calendula Cream (1 G, Daily)
  • Bonjela Complete Plus (1 Gtt, Daily)
  • Laxido (1 Df (sachet), Daily)
  • Cyclizine Hydrochloride (50 Mg, Daily)
  • Flucloxacillin (500 Mg, 4x/day)
  • Metoclopramide (10 Mg, Daily)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Temsirolimus side effects, such as febrile neutropenia.

Febrile Neutropenia
This febrile neutropenia side effect was reported by a physician from ES. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: hormone-refractory prostate cancer.The patient was prescribed Temsirolimus (dosage: 15 Mg, Cyclic (day 1 And Day 16/21 Days)), which was started on Aug 21, 2013. Concurrently used drugs:
  • Docetaxel (50 Mg/m2, Cyclic (21 Days))
.When starting to take Temsirolimus the consumer reported symptoms, such as:
  • Febrile Neutropenia
These side effects may potentially be related to Temsirolimus. The patient was hospitalized.

Disease Progression, Mantle Cell Lymphoma
This is a report of a 78-year-old male patient (weight: NA) from ES, suffering from the following symptoms/conditions: mantle cell lymphoma, who was treated with Temsirolimus (dosage: 75 Mg, Weekly (loading Dose And Maintenance Dose), start time: Dec 07, 2012), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Disease Progression
  • Mantle Cell Lymphoma
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Temsirolimus treatment in male patients, resulting in disease progression side effect.

Pyrexia
This report suggests a potential Temsirolimus Pyrexia side effect(s) that can have serious consequences. A 80-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: NA and used Temsirolimus (dosage: 25 Mg, 1x/day) starting Oct 10, 2012. Soon after starting Temsirolimus the patient began experiencing various side effects, including:
  • Pyrexia
Drugs used concurrently: NA.The patient was hospitalized. Although Temsirolimus demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as pyrexia, may still occur.

Interstitial Lung Disease, Pneumocystis Jirovecii Pneumonia
This Interstitial Lung Disease, Pneumocystis Jirovecii Pneumonia problem was reported by a physician from JP. A 48-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: metastatic renal cell carcinoma. On Jan 27, 2012 this consumer started treatment with Temsirolimus (dosage: 25 Mg, Weekly). The following drugs were being taken at the same time: NA. When commencing Temsirolimus, the patient experienced the following unwanted symptoms/side effects:
  • Interstitial Lung Disease
  • Pneumocystis Jirovecii Pneumonia
The patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as interstitial lung disease, may become evident only after a product is in use by the general population.

Atypical Pneumonia
This is a report of a 47-year-old female patient (weight: NA) from DE. The patient developed the following symptoms/conditions: NA and was treated with Temsirolimus (dosage: 50 Mg, Unk) starting May 28, 2013. Concurrently used drugs:
  • Rituximab (618.75 Mg, Unk)
  • Bendamustine (148.50 Mg, Unk)
Soon after that, the consumer experienced the following side effects:
  • Atypical Pneumonia
The patient was hospitalized. This opens a possibility that Temsirolimus treatment could cause the above reactions, including atypical pneumonia, and some female subjects may be more susceptible.

Gastric Antral Vascular Ectasia, Mucosal Haemorrhage
A 40-year-old female patient (weight: NA) from JP with the following symptoms/conditions: renal cell carcinoma started Temsirolimus treatment (dosage: 15 Mg, 1x/day) on 201206. Soon after starting Temsirolimus treatment, the subject experienced various side effects, including:
  • Gastric Antral Vascular Ectasia
  • Mucosal Haemorrhage
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Temsirolimus.

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Top 10 Temsirolimus Side Effects for Women

Women Side EffectsReports
Dyspnoea 23
Disease Progression 21
Deep Vein Thrombosis 20
Diarrhoea 16
Vomiting 16
Nausea 15
Pleural Effusion 15
Death 14
Dehydration 14
Hyperglycaemia 14

Top 10 Temsirolimus Side Effects for Men

Men Side EffectsReports
Disease Progression 63
Pneumonia 50
Pyrexia 50
Diarrhoea 46
Dehydration 45
Dyspnoea 44
Anaemia 39
Interstitial Lung Disease 38
Fatigue 34
Death 33

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    More About Temsirolimus

    Side Effects reported to FDA: 1225

    Temsirolimus safety alerts: No

    Reported deaths: 288

    Reported hospitalizations: 904

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