OpenClaim

Relebactam Side Effects

The most commonly reported side effects of relebactam include off label use, death, and pathogen resistance, based on 133 FDA adverse event reports from 2011 to 2025. 10.5% of reports found the drug to be ineffective.

Relebactam side effects

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

1
Off Label Use17.3%23
2
Death11.3%15
3
Drug Ineffective10.5%14
4
Pathogen Resistance9.8%13
5
Product Use In Unapproved Indication7.5%10
6
Dyspnoea4.5%6
7
Sepsis4.5%6
8
Thrombocytopenia4.5%6
9
Cough3.8%5
10
Drug Dose Omission3.8%5
11
Arthralgia3.8%5
12
Cardio-respiratory Arrest3.8%5
13
Generalised Tonic-clonic Seizure3.8%5
14
Overdose3.8%5
15
Renal Failure3.8%5

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

Report severity

75.2%Serious100 reports
22.6%Hospitalizations30 reports
21.1%Fatal28 reports

Seriousness is determined by the reporter, not by OpenClaim.

Relebactam drug interactions

Other drugs that appear in adverse event reports alongside relebactam. 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
Imipenem66.2%88
2
Cilastatin-sodium63.9%85
3
Amikacin-sulfate8.3%11
4
Meropenem6.8%9
5
Cefiderocol-sulfate-tosylate6.0%8
6
Budesonide3.8%5
7
Formoterol3.8%5
8
Pregabalin3.8%5
9
Tigecycline3.8%5
10
Vancomycin3.8%5
11
Tiotropium-bromide3.0%4
12
Aclidinium-bromide3.0%4
13
Acyclovir3.0%4
14
Lactulose3.0%4
15
Remifentanil-hydrochloride3.0%4

Taken alongside

1
Cilastatin-sodium29.3%39
2
Imipenem29.3%39
3
Albuterol12.0%16
4
Prednisone6.8%9
5
Tiotropium-bromide6.0%8
6
Ergocalciferol6.0%8
7
Levothyroxine-sodium5.3%7
8
Fentanyl5.3%7
9
Lisinopril4.5%6
10
Furosemide4.5%6
11
Insulin4.5%6
12
Gabapentin4.5%6
13
Meropenem4.5%6
14
Vancomycin4.5%6
15
Heparin4.5%6

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 relebactam side effects

47.4% of relebactam adverse event reports involve female patients and 49.6% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.4%
Male49.6%
Unknown3.0%

Age group

< 20.0%
2–111.0%
12–170.0%
18–6461.2%
65+37.8%

What is relebactam used for

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

Abdominal AbscessAbdominal InfectionAchromobacter InfectionAnal AbscessAnti-infective TherapyAntibiotic TherapyArthritis InfectiveAsthmaBronchitis ChronicBacteraemiaBacterial InfectionBurkholderia Cepacia Complex InfectionChronic Obstructive Pulmonary DiseaseCovid-19Clostridium Difficile Infection

Showing 15 of 54 indications

Relebactam brand names and reporting trend

Relebactam is sold under the brand name Recarbrio.

Brand names

Recarbrio16

Quarterly reports (20112025)

20112016202020242025

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

Taking relebactam with another medication?

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