Pharmacologic class (EPC) · 6 drug pages

Penem antibacterial: adverse event reports filed with FDA

23,429 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

23,429
reports across the class: 0.1% of all reports; 1,980
reports, 12 months to June 2026: 2,330 in the 12 months before; 94.1%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Penem antibacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 23,429 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,980 reports arrived in the 12 months to June 2026, down 15% from 2,330 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 94.1% of the class's reports are marked serious, 22.4% record death among the outcomes and 48.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (19%), off label use (9.2%) and pyrexia (5.1%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Meropenem	generic	15,365	1,505	97.6%	Drug ineffective
InvanzErtapenem sodium	brand	2,800	94	74.6%	Product use in unapproved indication
Ertapenem	generic	1,686	276	90.1%	Drug ineffective
Imipenem and cilastatin sodium	generic	1,276	10	96.2%	Convulsion
Imipenem and cilastatin	generic	1,229	59	97%	Drug ineffective
Ertapenem sodium	generic	1,073	36	96.2%	Drug ineffective

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected19%4,441
Off label useused for a purpose or in a way not on the label9.2%2,162
Pyrexiafever5.1%1,198
Condition aggravatedthe condition being treated got worse4.1%949
Product use in unapproved indicationused for a purpose not on the label3.6%844
Macular degenerationa disease of the central retina3.5%817
Septic shockshock arising from infection3.4%787
Multiple organ dysfunction syndromeseveral organs failing3%709
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.9%687
Drug interactionan interaction between medicines2.9%685
Drug resistance2.9%671
Thrombocytopenialow platelets2.8%645
Nauseafeeling sick2.6%608
Rashskin rash2.6%607
Sepsisa severe body-wide response to infection2.6%601
Diarrhoealoose or frequent stools2.5%596
Acute kidney injurysudden loss of kidney function2.5%595
Anaemialow red blood cells2.4%556
Confusional stateconfusion2.3%528
Pathogen resistance2.2%507
Pneumonialung infection2.1%503
Respiratory failurethe lungs could not supply enough oxygen2%467
Neutropenialow neutrophils, a type of white blood cell1.9%451
Convulsion1.9%445
Dyspnoeashortness of breath1.9%435

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death22.4%5,245

Life-threatening13.8%3,242

Hospitalisation (initial or prolonged)48.7%11,412

Disability1.8%425

Congenital anomaly0.2%47

Other serious61%14,297

Not serious5.9%1,378

Patient age

Under 22.5%585

2 to 113.3%770

12 to 172.4%565

18 to 4417%3,989

45 to 6424.7%5,793

65 to 7416.5%3,872

75 and over16.3%3,817

Age not given17.2%4,038

Who reported

Physician31.6%7,404

Pharmacist10.7%2,502

Other health professional48%11,236

Lawyer0%7

Consumer or non-health professional7.8%1,829

Not given1.9%451

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Penem antibacterial reports

Which drugs are in the Penem antibacterial class on this site?

Meropenem, Invanz, Ertapenem, Imipenem and cilastatin sodium, Imipenem and cilastatin and Ertapenem sodium. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

23,429 reports through June 2026, 1,980 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (19%), off label use (9.2%), pyrexia (5.1%), condition aggravated (4.1%) and product use in unapproved indication (3.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.