Imipenem and cilastatin adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Imipenem and cilastatin
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Penem antibacterial
Also reported as: Imipenem/Cilastatin

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From March 2005 to June 2026, FDA received 1,229 adverse event reports that name Imipenem and cilastatin. In these reports the drug is a suspect or interacting product.

In the same period, 498 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 59 reports in the 12 months to June 2026 and 63 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 59 (under 0.1%) name Imipenem and cilastatin. Reports from other health professionals were 58.6% of the reports that name Imipenem and cilastatin and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Imipenem and cilastatin is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 15 reports that name Imipenem and cilastatin.
In January to March 2026, FDA received 15.
In April to June 2025, FDA received 5.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 131 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,198 of the 1,229 reports (97.5%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 131 terms.

Reaction terms in the reports that name Imipenem and cilastatin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,229 reports
Drug ineffectivethe medicine did not work as expected	182	14.8%
Off label useused for a purpose or in a way not on the label	80	6.5%
Pathogen resistance	73	5.9%
Product use in unapproved indicationused for a purpose not on the label	65	5.3%
Pyrexiafever	51	4.1%
Epilepsy	41	3.3%
Vomitingbeing sick	41	3.3%
Condition aggravatedthe condition being treated got worse	38	3.1%
Septic shockshock arising from infection	37	3%
Drug resistance	36	2.9%
Electrocardiogram QT prolongeda QT prolongation on the ECG	36	2.9%
Thrombocytopenialow platelets	34	2.8%
Anaemialow red blood cells	33	2.7%
Diarrhoealoose or frequent stools	33	2.7%
Dyspnoeashortness of breath	33	2.7%
Nauseafeeling sick	33	2.7%
Respiratory failurethe lungs could not supply enough oxygen	33	2.7%
Treatment failurethe treatment did not work	32	2.6%
Acute kidney injurysudden loss of kidney function	27	2.2%
Seizurea fit or convulsion	25	2%
Deaththe patient died; cause not stated by this term	23	1.9%
Klebsiella infection	22	1.8%
Rash maculo-papulara rash of flat and raised spots	22	1.8%
Sepsisa severe body-wide response to infection	22	1.8%
Infectionan infection, type not specified	20	1.6%
Platelet count decreasedlow platelet count	20	1.6%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	19	1.5%
Hepatotoxicityliver injury	19	1.5%
Multiple organ dysfunction syndromeseveral organs failing	19	1.5%
Confusional stateconfusion	18	1.5%
Pneumonialung infection	18	1.5%
Toxic skin eruption	18	1.5%
Acute generalised exanthematous pustulosis	17	1.4%
Drug interactionan interaction between medicines	17	1.4%
General physical health deteriorationgeneral decline in health	16	1.3%
Rashskin rash	16	1.3%
Haemoglobin decreasedlow haemoglobin	15	1.2%
Hypokalaemialow blood potassium	15	1.2%
Neuropathy peripheralnerve damage in hands or feet	15	1.2%
Aspartate aminotransferase increasedraised liver enzyme (AST)	14	1.1%
Drug-induced liver injury	14	1.1%
Decreased appetitereduced appetite	13	1.1%
Intentional product use issuedeliberate use not as intended	13	1.1%
Neutropenialow neutrophils, a type of white blood cell	13	1.1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	12	1%
Eosinophilia	12	1%
Loss of consciousnesspassing out	12	1%
Mycobacterium abscessus infection	12	1%
Astheniaweakness or lack of energy	11	0.9%
Clostridium difficile infection	11	0.9%

Download all 131 terms of Imipenem and cilastatin (CSV)

The counts add to more than 1,229 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Imipenem and cilastatin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Imipenem and cilastatin (this page)	Generic name	1,229
Imipenem and cilastatin sodium	Generic name	1,276

Sum of the separately reported names: 2,505. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Imipenem and cilastatin, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2005	2	1	0	1	1	0	0	0	1
2006	4	1	0	1	0	0	0	0	3
2009	2	1	0	0	1	0	0	0	1
2010	27	27	4	1	20	1	0	11	0
2011	2	2	0	0	2	0	0	1	0
2012	8	8	2	1	6	0	0	4	0
2013	13	13	0	1	7	0	0	7	0
2014	22	22	4	1	10	1	0	12	0
2015	52	46	13	4	24	1	0	23	6
2016	79	78	10	14	43	0	0	43	1
2017	104	102	28	12	47	1	0	66	2
2018	199	197	55	13	73	6	1	137	2
2019	194	191	54	16	102	11	0	131	3
2020	117	116	34	8	48	7	0	86	1
2021	88	85	23	8	36	0	0	64	3
2022	70	68	17	14	17	2	0	47	2
2023	65	64	9	2	25	1	1	48	1
2024	77	73	25	4	33	1	0	46	4
2025	67	64	18	9	27	0	1	48	3
2026	37	33	9	2	17	0	0	21	4

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Imipenem and cilastatin, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Imipenem and cilastatin, by the year in which FDA received them
Year	Reports
2005	2
2006	4
2009	1
2010	26
2011	5
2012	11
2013	19
2014	23
2015	52
2016	89
2017	112
2018	203
2019	202
2020	114
2021	84
2022	63
2023	63
2024	76
2025	50
2026	30

Reports that name Imipenem and cilastatin, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Imipenem and cilastatin
Age	Reports	Share
Under 2	14	1.1%
2 to 11	45	3.7%
12 to 17	22	1.8%
18 to 44	283	23%
45 to 64	367	29.9%
65 to 74	190	15.5%
75 and over	173	14.1%
Age not given	135	11%

Sex of the patient in the reports that name Imipenem and cilastatin
Sex	Reports	Share
Female	492	40%
Male	660	53.7%
Unknown or not given	77	6.3%

Type of reporter in the reports that name Imipenem and cilastatin
Reporter	Reports	Share
Physician	292	23.8%
Pharmacist	77	6.3%
Other health professional	720	58.6%
Lawyer	1	0.1%
Consumer or non-health professional	129	10.5%
Not given	10	0.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 10.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Imipenem and cilastatin record
Indication as recorded (MedDRA)	Reports	Share
Tuberculosis	121	9.8%
Infection	85	6.9%
Antibiotic therapy	59	4.8%
Anti-infective therapy	57	4.6%
Pneumonia	47	3.8%
Pulmonary tuberculosis	44	3.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,229 reports.

Drugs in the same reports

Other drugs that the reports of Imipenem and cilastatin name, in any role, in order of name
Drug	Reports that name the two
Amikacin	180
Bedaquiline	148
Ciprofloxacin	69
Clofazimine	212
Linezolid	297
Meropenem	123
Moxifloxacin	85
Piperacillin and tazobactam	90
Tigecycline	83
Vancomycin	239

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Imipenem and cilastatin sodium same ingredient
Ertapenem sodium same class
Ertapenem same class
Invanz same class
Meropenem same class
Imipenem next in the A to Z list
Imigran next in the A to Z list
Imipramine next in the A to Z list
Imiglucerase next in the A to Z list
Imipramine hydrochloride next in the A to Z list
Imfinzi next in the A to Z list
Imiquimod next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Imipenem and cilastatinThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Imipenem and cilastatin: adverse event reports that FDA received. https://reportedreactions.com/drug/imipenem-and-cilastatin/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Imipenem and cilastatin as a suspect or interacting product. The 498 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Imipenem and cilastatin was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Imipenem and cilastatin?

No. It is a count of what people reported to FDA: 1,229 reports from March 2005 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (58.6%), physician (23.8%) and consumer or non-health professional (10.5%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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