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Gemcitabine Side Effects

The most commonly reported side effects of gemcitabine include off label use, disease progression, and thrombocytopenia, based on 64,202 FDA adverse event reports from 2004 to 2025. 4.3% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: CisplatinDrug interactions ↓52% of Reports Are AdultDemographics ↓

Gemcitabine side effects

Percentages show how often each reaction appears relative to total reports for gemcitabine.

1
Off Label Use7.5%4,807
2
Disease Progression7.4%4,755
3
Thrombocytopenia5.6%3,616
4
Malignant Neoplasm Progression5.0%3,208
5
Neutropenia4.9%3,128
6
Anaemia4.7%2,994
7
Drug Ineffective4.3%2,734
8
Death4.2%2,724
9
Nausea4.1%2,648
10
Pyrexia3.8%2,454
11
Fatigue3.6%2,321
12
Diarrhoea3.3%2,097
13
Vomiting3.2%2,030
14
Febrile Neutropenia2.7%1,728
15
Dyspnoea2.5%1,619

These are voluntary reports and do not establish that gemcitabine caused these reactions.

Report severity

96.4%Serious61,873 reports
41.3%Hospitalizations26,505 reports
21.1%Fatal13,552 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gemcitabine drug interactions

Other drugs that appear in adverse event reports alongside gemcitabine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Cisplatin19.2%12,303
2
Paclitaxel17.9%11,479
3
Carboplatin14.6%9,377
4
Oxaliplatin9.8%6,319
5
Doxorubicin-hydrochloride8.8%5,675
6
Rituximab8.1%5,198
7
Cyclophosphamide7.4%4,763
8
Bevacizumab6.5%4,200
9
Vincristine-sulfate6.0%3,821
10
Dexamethasone5.9%3,798
11
Docetaxel5.6%3,593
12
Capecitabine5.2%3,320
13
Etoposide4.6%2,941
14
Prednisone4.3%2,773
15
Vinorelbine-tartrate3.8%2,421

Taken alongside

1
Dexamethasone8.1%5,170
2
Ondansetron5.8%3,734
3
Cisplatin5.7%3,666
4
Acetaminophen5.6%3,603
5
Carboplatin4.5%2,899
6
Paclitaxel3.5%2,259
7
Pantoprazole-sodium3.5%2,234
8
Omeprazole3.5%2,231
9
Oxycodone3.2%2,025
10
Aspirin3.0%1,906
11
Metoclopramide-hydrochloride2.8%1,784
12
Furosemide2.8%1,783
13
Prochlorperazine2.3%1,500
14
Docetaxel2.3%1,484
15
Amlodipine2.3%1,473

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports gemcitabine side effects

41.6% of gemcitabine adverse event reports involve female patients and 42.5% involve male patients. The largest age group is adult at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.6%
Male42.5%
Unknown15.9%

Age group

< 20.1%
2–110.4%
12–171.1%
18–6451.8%
65+46.5%

What is gemcitabine used for

Conditions and purposes for which patients were taking gemcitabine when the adverse event was reported.

Abdominal NeoplasmAbdominal PainAbdominal Wall NeoplasmAbdominal Wall Neoplasm MalignantAccidental Exposure To ProductAcinar Cell Carcinoma Of PancreasAcquired Gene MutationAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma LungAdenocarcinoma MetastaticAdenocarcinoma Of Colon

Showing 15 of 1,670 indications

Gemcitabine brand names and reporting trend

Gemcitabine is sold under brand names including Gemcitabine, Inlexzo.

Brand names

Gemcitabine67,834
Inlexzo30

Quarterly reports (2004–2025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking gemcitabine with another medication?

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