OpenClaim

Cilastatin Side Effects

The most commonly reported side effects of cilastatin include product use in unapproved indication, off label use, and convulsion, based on 4,109 FDA adverse event reports from 2004 to 2025. 7.1% of reports found the drug to be ineffective.

Cilastatin side effects

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

1
Product Use In Unapproved Indication7.3%302
2
Drug Ineffective7.1%290
3
Off Label Use6.3%259
4
Convulsion4.3%177
5
Pyrexia2.9%118
6
Pathogen Resistance2.7%110
7
Nausea2.5%101
8
Vomiting2.4%98
9
Pyrexia2.3%95
10
Sepsis2.3%94
11
Pneumonia2.1%86
12
Thrombocytopenia2.1%85
13
Drug Ineffective2.0%81
14
Diarrhoea2.0%81
15
Dyspnoea2.0%81

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

Report severity

87.5%Serious3,595 reports
43.6%Hospitalizations1,791 reports
23.5%Fatal966 reports

Seriousness is determined by the reporter, not by OpenClaim.

Cilastatin drug interactions

Other drugs that appear in adverse event reports alongside cilastatin. 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
Imipenem71.0%2,917
2
Vancomycin11.1%458
3
Linezolid11.0%454
4
Amikacin-sulfate6.8%279
5
Clofazimine6.4%264
6
Ciprofloxacin5.0%207
7
Bedaquiline-fumarate4.6%189
8
Meropenem3.9%159
9
Moxifloxacin-hydrochloride3.4%139
10
Methylprednisolone3.1%129
11
Azithromycin3.0%125
12
Tigecycline3.0%125
13
Piperacillin2.9%121
14
Amoxicillin2.9%118
15
Fluconazole2.8%114

Taken alongside

1
Imipenem24.3%999
2
Vancomycin10.3%422
3
Amikacin-sulfate8.4%347
4
Furosemide6.9%283
5
Acetaminophen6.7%274
6
Fluconazole5.6%229
7
Omeprazole5.3%216
8
Pantoprazole-sodium4.9%203
9
Linezolid4.7%195
10
Insulin4.5%185
11
Ciprofloxacin4.4%181
12
Prednisone4.3%178
13
Methylprednisolone4.2%171
14
Sulfamethoxazole4.1%168
15
Heparin4.0%164

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 cilastatin side effects

40.0% of cilastatin adverse event reports involve female patients and 53.4% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female40.0%
Male53.4%
Unknown6.6%

Age group

< 21.6%
2–113.5%
12–172.1%
18–6455.5%
65+37.2%

What is cilastatin used for

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

Abdominal AbscessAbdominal InfectionAbdominal RigidityAbdominal SepsisAbdominal Wall InfectionAbscessAbscess BacterialAbscess LimbAchromobacter InfectionAcinetobacter BacteraemiaAcinetobacter InfectionActinomycosisAcute Febrile Neutrophilic DermatosisAcute Graft Versus Host DiseaseAcute Lymphocytic Leukaemia

Showing 15 of 556 indications

Cilastatin brand names and reporting trend

Cilastatin is sold under the brand name Primaxin.

Brand names

Primaxin417

Quarterly reports (20042025)

20052010201520202025

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

Taking cilastatin with another medication?

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