What the label lists and what reports show

Cilastatin and imipenem side effects

Cilastatin and imipenem's FDA label lists its adverse reactions in its own words. FAERS holds 4,053 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (210 reports).

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Check it at the source: the cilastatin and imipenem FDA label on DailyMed (effective July 5, 2024, Merck Sharp & Dohme LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The following serious adverse reactions are described in greater detail in the Warnings and Precautions section. Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Seizure Potential [see Warnings and Precautions (5.2) ] Increased Seizure Potential Due to Interaction with Valproic Acid [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.4) ] Development of Drug-Resistant Bacteria [see Warnings and Precautions (5.5) ] The most frequently occurring adverse reactions (≥0.2%) in adults were phlebitis, nausea, diarrhea, vomiting, rash, pain injection site, fever, hypotension, seizures, erythema at injection site, dizziness, pruritus, vein induration, urticaria, somnolence ( 6.1 ). …

Table 4: Incidence (%) Adverse reactions with an incidence ≥0.2% of PRIMAXIN-treated adult patients. of Adverse Reactions Reported During Clinical Investigations of Adult Patients Treated with PRIMAXIN

Adverse Reactions	Frequency (%)
Phlebitis/thrombophlebitis	3.1%
Nausea	2.0%
Rash	0.9%
Hypotension	0.4%
Fever	0.5%
Seizures	0.4%

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

Source: FDA drug label, Merck Sharp & Dohme LLC, effective July 5, 2024 (SPL set f41d8abd-7792-4918-1b93-bd83ea01955e), via openFDA; the full label on DailyMed

What do FAERS reports show?

4,053 reports list cilastatin and imipenem among the medicines taken, each a report of something that happened, not proof the medicine caused it; 954 are coded as a death and 1,832 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Drug Ineffective (a use or a product term, not a reaction)351
Product Use In Unapproved Indication (a use or a product term, not a reaction)299
Off Label Use (a use or a product term, not a reaction)246
Pyrexia210
Convulsion (named in the label)191
Pneumonia160
Sepsis153
Thrombocytopenia142
Septic Shock127
Death (an outcome recorded in the report)122
Nausea (named in the label)122
Pathogen Resistance115
Anaemia112
Vomiting (named in the label)112
Respiratory Failure110
Diarrhoea (named in the label)109
Rash (named in the label)108
Platelet Count Decreased98
Dyspnoea (named in the label)96
Drug Interaction (a use or a product term, not a reaction)94
Condition Aggravated (a use or a product term, not a reaction)84
Renal Failure (named in the label)83
Multi-Organ Failure79
Hypotension (named in the label)74
Epilepsy73

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cilastatin and imipenem: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions