CILASTATIN\IMIPENEM: 4,873 Adverse Event Reports & Safety Profile
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4,873
Total FAERS Reports
643 (13.2%)
Deaths Reported
1,798
Hospitalizations
4,873
As Primary/Secondary Suspect
456
Life-Threatening
111
Disabilities
Active Ingredient: CILASTATIN SODIUM\IMIPENEM ·
First Report: 19911104 · Latest Report: 20250923
What Are the Most Common CILASTATIN\IMIPENEM Side Effects?
#1 Most Reported
Epilepsy
615 reports (12.6%)
#2 Most Reported
Product use in unapproved indication
385 reports (7.9%)
#3 Most Reported
Drug ineffective
321 reports (6.6%)
All CILASTATIN\IMIPENEM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Epilepsy | 615 | 12.6% | 3 | 128 |
| Product use in unapproved indication | 385 | 7.9% | 25 | 53 |
| Drug ineffective | 321 | 6.6% | 133 | 122 |
| Delirium | 309 | 6.3% | 1 | 53 |
| Off label use | 248 | 5.1% | 58 | 81 |
| Pyrexia | 168 | 3.5% | 47 | 104 |
| Seizure | 155 | 3.2% | 15 | 59 |
| Nausea | 145 | 3.0% | 12 | 52 |
| Vomiting | 133 | 2.7% | 16 | 48 |
| Diarrhoea | 122 | 2.5% | 27 | 64 |
| Drug reaction with eosinophilia and systemic symptoms | 122 | 2.5% | 12 | 90 |
| Pathogen resistance | 122 | 2.5% | 39 | 54 |
| Dyspnoea | 115 | 2.4% | 32 | 60 |
| Condition aggravated | 103 | 2.1% | 31 | 62 |
| Pneumonia | 98 | 2.0% | 37 | 59 |
| Confusional state | 96 | 2.0% | 6 | 65 |
| Thrombocytopenia | 96 | 2.0% | 19 | 58 |
| Mental disorder | 95 | 2.0% | 0 | 29 |
| Septic shock | 94 | 1.9% | 62 | 48 |
| Muscle twitching | 93 | 1.9% | 0 | 25 |
Who Reports CILASTATIN\IMIPENEM Side Effects? Age & Gender Data
Gender: 41.1% female, 58.9% male. Average age: 58.4 years. Most reports from: CN. View detailed demographics →
Is CILASTATIN\IMIPENEM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 0 | 2 |
| 2001 | 1 | 0 | 1 |
| 2002 | 2 | 1 | 2 |
| 2003 | 1 | 0 | 1 |
| 2004 | 4 | 4 | 1 |
| 2005 | 2 | 1 | 2 |
| 2006 | 4 | 1 | 3 |
| 2007 | 2 | 0 | 1 |
| 2008 | 9 | 0 | 8 |
| 2009 | 18 | 4 | 15 |
| 2010 | 18 | 6 | 15 |
| 2011 | 11 | 2 | 4 |
| 2012 | 29 | 1 | 19 |
| 2013 | 42 | 9 | 34 |
| 2014 | 104 | 9 | 65 |
| 2015 | 166 | 15 | 87 |
| 2016 | 202 | 22 | 108 |
| 2017 | 273 | 32 | 132 |
| 2018 | 379 | 119 | 140 |
| 2019 | 337 | 46 | 149 |
| 2020 | 266 | 32 | 96 |
| 2021 | 363 | 28 | 132 |
| 2022 | 496 | 20 | 139 |
| 2023 | 536 | 7 | 173 |
| 2024 | 242 | 1 | 85 |
| 2025 | 124 | 4 | 41 |
What Is CILASTATIN\IMIPENEM Used For?
| Indication | Reports |
|---|---|
| Pneumonia | 587 |
| Anti-infective therapy | 556 |
| Infection | 537 |
| Product used for unknown indication | 277 |
| Mycobacterium abscessus infection | 197 |
| Sepsis | 185 |
| Tuberculosis | 177 |
| Antibiotic therapy | 170 |
| Nocardiosis | 116 |
| Lung infection | 104 |
CILASTATIN\IMIPENEM vs Alternatives: Which Is Safer?
CILASTATIN\IMIPENEM vs CILAZAPRIL ANHYDROUS
CILASTATIN\IMIPENEM vs CILGAVIMAB\TIXAGEVIMAB
CILASTATIN\IMIPENEM vs CILOSTAZOL
CILASTATIN\IMIPENEM vs CILTACABTAGENE AUTOLEUCEL
CILASTATIN\IMIPENEM vs CIMETIDINE
CILASTATIN\IMIPENEM vs CIMZIA
CILASTATIN\IMIPENEM vs CINACALCET
CILASTATIN\IMIPENEM vs CINNARIZINE
CILASTATIN\IMIPENEM vs CINRYZE
CILASTATIN\IMIPENEM vs CIPRO
Official FDA Label for CILASTATIN\IMIPENEM
Official prescribing information from the FDA-approved drug label.