ERTAPENEM: 4,069 Adverse Event Reports & Safety Profile
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4,069
Total FAERS Reports
223 (5.5%)
Deaths Reported
1,617
Hospitalizations
4,069
As Primary/Secondary Suspect
266
Life-Threatening
68
Disabilities
Apr 16, 2018
FDA Approved
Merck Sharp & Dohme LLC
Manufacturer
Prescription
Status
Yes
Generic Available
Active Ingredient: ERTAPENEM SODIUM · Drug Class: Carbapenems [CS] · Route: INTRAMUSCULAR · Manufacturer: Merck Sharp & Dohme LLC · FDA Application: 021337 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20070417 · Latest Report: 20250911
What Are the Most Common ERTAPENEM Side Effects?
#1 Most Reported
Drug ineffective
1,001 reports (24.6%)
#2 Most Reported
Macular degeneration
776 reports (19.1%)
#3 Most Reported
Off label use
372 reports (9.1%)
All ERTAPENEM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 1,001 | 24.6% | 38 | 302 |
| Macular degeneration | 776 | 19.1% | 0 | 220 |
| Off label use | 372 | 9.1% | 14 | 245 |
| Product use in unapproved indication | 346 | 8.5% | 6 | 51 |
| Pyrexia | 279 | 6.9% | 14 | 258 |
| Nausea | 277 | 6.8% | 2 | 230 |
| Confusional state | 263 | 6.5% | 8 | 185 |
| Pain | 255 | 6.3% | 1 | 216 |
| Malaise | 220 | 5.4% | 3 | 210 |
| Weight decreased | 220 | 5.4% | 2 | 207 |
| Therapeutic product effect incomplete | 208 | 5.1% | 0 | 203 |
| Paraesthesia oral | 206 | 5.1% | 0 | 201 |
| Chronic sinusitis | 204 | 5.0% | 0 | 201 |
| Seizure | 200 | 4.9% | 17 | 102 |
| Infusion related reaction | 198 | 4.9% | 1 | 189 |
| Anaemia | 188 | 4.6% | 16 | 181 |
| Dyspepsia | 186 | 4.6% | 0 | 182 |
| Procedural pain | 182 | 4.5% | 0 | 179 |
| Headache | 177 | 4.4% | 1 | 161 |
| Hallucination | 172 | 4.2% | 5 | 98 |
Who Reports ERTAPENEM Side Effects? Age & Gender Data
Gender: 54.5% female, 45.5% male. Average age: 64.1 years. Most reports from: US. View detailed demographics →