Aminoglycoside Antibacterial side effects compared: 5 drugs, 66,824 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Tobramycin (Bethkis) | 23,907 | 77% | 2,819 | – | Infective pulmonary exacerbation of cystic fibrosis; Pseudomonas infection; Pulmonary function test decreased | Sputum increased; Choroiditis |
| Amikacin (Arikayce) | 16,955 | 82% | 3,387 | boxed | Aphonia; Mycobacterium avium complex infection; Ototoxicity | Sputum retention; Pulmonary cavitation |
| Tobramycin (Bethkis) | 12,308 | 81% | 1,279 | – | Infective pulmonary exacerbation of cystic fibrosis; Pseudomonas infection; Pulmonary function test decreased | Choroiditis; Mycobacterium chelonae infection |
| Tobramycin (Bethkis) | 11,940 | 81% | 1,232 | – | Infective pulmonary exacerbation of cystic fibrosis; Pseudomonas infection; Pulmonary function test decreased | Choroiditis; Mycobacterium chelonae infection |
| Amikacin (Arikayce) | 1,714 | 94% | 423 | boxed | Multiple organ dysfunction syndrome; Deafness; Cardiovascular disorder | Sepsis; Febrile neutropenia |
Class-wide signals (flagged in at least 3 of 5 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Infective exacerbation of bronchiectasis | 4/5 | 98.9 | 95 | 1/4 members' labels |
| Ototoxicity | 4/5 | 80.0 | 443 | 4/4 members' labels |
| Mycobacterium chelonae infection | 4/5 | 71.4 | 133 | 1/4 members' labels |
| Increased viscosity of bronchial secretion | 4/5 | 53.6 | 122 | 1/4 members' labels |
| Respiratory tract irritation | 4/5 | 39.9 | 125 | 1/4 members' labels |
| Choroiditis | 3/5 | 350.2 | 192 | 0/3 members' labels |
| Infective keratitis | 3/5 | 313.2 | 34 | 0/3 members' labels |
| Acquired factor v deficiency | 3/5 | 245.0 | 42 | 0/3 members' labels |
| Infective pulmonary exacerbation of cystic fibrosis | 3/5 | 218.7 | 2,804 | 3/3 members' labels |
| Cystic fibrosis respiratory infection suppression | 3/5 | 189.5 | 338 | 3/3 members' labels |
| Cystic fibrosis lung | 3/5 | 177.6 | 57 | 0/3 members' labels |
| Cystic fibrosis | 3/5 | 141.3 | 2,118 | 0/3 members' labels |
| Ventilation perfusion mismatch | 3/5 | 136.9 | 63 | 0/3 members' labels |
| Keratitis fungal | 3/5 | 135.5 | 45 | 0/3 members' labels |
| Cystic fibrosis related diabetes | 3/5 | 130.2 | 46 | 0/3 members' labels |
| Keratitis bacterial | 3/5 | 125.7 | 33 | 0/3 members' labels |
| Sle arthritis | 3/5 | 101.1 | 48 | 0/3 members' labels |
| Corneal infiltrates | 3/5 | 93.0 | 52 | 0/3 members' labels |
| Corneal neovascularisation | 3/5 | 84.0 | 35 | 0/3 members' labels |
| Elbow deformity | 3/5 | 81.9 | 48 | 0/3 members' labels |
| Vitamin k deficiency | 3/5 | 80.6 | 55 | 0/3 members' labels |
| Corneal thinning | 3/5 | 77.0 | 35 | 0/3 members' labels |
| Corneal perforation | 3/5 | 73.6 | 78 | 0/3 members' labels |
| Corneal epithelium defect | 3/5 | 64.6 | 67 | 0/3 members' labels |
| Trichosporon infection | 3/5 | 57.8 | 42 | 0/3 members' labels |
| Tracheitis | 3/5 | 53.1 | 82 | 0/3 members' labels |
| Pulmonary function test decreased | 3/5 | 52.6 | 683 | 3/3 members' labels |
| Pseudomonas infection | 3/5 | 52.1 | 1,043 | 3/3 members' labels |
| Lung infection pseudomonal | 3/5 | 49.6 | 73 | 0/3 members' labels |
| Pneumonia pseudomonal | 3/5 | 43.7 | 144 | 0/3 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Mycobacterium avium complex infection | Amikacin | 383 | 208.1 | Labeled (related wording) |
| Sputum retention | Amikacin | 71 | 96.8 | Not in label — unassessed |
| Mycobacterial infection | Amikacin | 67 | 50.0 | Labeled (related wording) |
| Aphonia | Amikacin | 507 | 46.6 | Labeled adverse reaction |
| Septic shock | Amikacin | 52 | 14.8 | Not in label — unassessed |
| Febrile neutropenia | Amikacin | 61 | 11.3 | Not in label — unassessed |
| Sepsis | Amikacin | 83 | 9.1 | Not in label — unassessed |
Common questions
Which aminoglycoside antibacterial has the most FDA adverse event reports?
Tobramycin has the most FAERS co-reports in this class (23,907), followed by Amikacin (16,955). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across aminoglycoside antibacterial drugs?
Reaction terms flagged in at least half of the 5 members include infective exacerbation of bronchiectasis, ototoxicity, mycobacterium chelonae infection, increased viscosity of bronchial secretion, respiratory tract irritation. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.