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Leuprolide Side Effects

The most commonly reported side effects of leuprolide include hot flush, death, and intercepted product preparation error, based on 90,643 FDA adverse event reports from 2004 to 2025. 3.0% of reports found the drug to be ineffective.

Leuprolide side effects

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

1
Hot Flush11.4%10,304
2
Death9.9%8,942
3
Intercepted Product Preparation Error9.8%8,862
4
Syringe Issue8.7%7,876
5
Fatigue7.4%6,673
6
Device Leakage6.6%6,019
7
Wrong Technique In Product Usage Process5.8%5,256
8
Injection Site Pain5.4%4,861
9
Prostatic Specific Antigen Increased3.3%2,959
10
Asthenia3.2%2,938
11
Drug Ineffective3.0%2,730
12
Off Label Use2.9%2,645
13
Arthralgia2.6%2,360
14
Pain2.6%2,349
15
Fall2.5%2,275

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

Report severity

47.5%Serious43,080 reports
16.2%Hospitalizations14,726 reports
14.6%Fatal13,241 reports

Seriousness is determined by the reporter, not by OpenClaim.

Leuprolide drug interactions

Other drugs that appear in adverse event reports alongside leuprolide. 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
Enzalutamide6.7%6,062
2
Abiraterone-acetate3.1%2,781
3
Bicalutamide1.7%1,506
4
Norethindrone1.3%1,164
5
Docetaxel1.3%1,134
6
Prednisone1.1%993
7
Denosumab1.0%940
8
Apalutamide0.8%715
9
Zoledronic-acid0.7%677
10
Palbociclib0.6%539
11
Letrozole0.5%445
12
Follitropin-alfa-beta0.4%335
13
Cabazitaxel0.4%325
14
Relugolix0.3%263
15
Acetaminophen0.3%256

Taken alongside

1
Aspirin4.5%4,073
2
Ergocalciferol4.2%3,825
3
Acetaminophen4.1%3,705
4
Bicalutamide3.6%3,220
5
Calcium3.3%3,025
6
Prednisone3.2%2,910
7
Atorvastatin-calcium3.1%2,788
8
Tamsulosin-hydrochloride3.0%2,747
9
Amlodipine2.9%2,627
10
Denosumab2.5%2,310
11
Metoprolol2.5%2,295
12
Metformin2.5%2,257
13
Omeprazole2.2%1,970
14
Lisinopril2.2%1,957
15
Levothyroxine-sodium2.1%1,892

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 leuprolide side effects

22.1% of leuprolide adverse event reports involve female patients and 68.5% involve male patients. The largest age group is elderly at 65%. These figures reflect who reports side effects, not underlying risk.

Sex

Female22.1%
Male68.5%
Unknown9.5%

Age group

< 20.1%
2–114.2%
12–171.3%
18–6429.3%
65+65.1%

What is leuprolide used for

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

Abdominal AdhesionsAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbnormal BehaviourAccidental ExposureAccidental Exposure To ProductAccidental Needle StickAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma MetastaticAdenocarcinoma Of Salivary GlandAdenoma BenignAdenomyosis

Showing 15 of 872 indications

Leuprolide brand names and reporting trend

Leuprolide is sold under brand names including Fensolvi Kit, Camcevi Etm.

Brand names

Fensolvi Kit7,810
Camcevi Etm1,562

Quarterly reports (20042025)

20052010201520202025

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

Taking leuprolide with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.