Drug
Omadacycline
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Incorrect Product Administration Duration | 88 | 55.6 | 58.7 | signal |
| 2 | Drug Resistance | 39 | 19.4 | 19.9 | signal |
| 3 | Electrocardiogram Qt Prolonged | 43 | 15.3 | 15.7 | signal |
| 4 | Hepatic Function Abnormal | 42 | 14.5 | 14.8 | signal |
| 5 | Cytopenia | 13 | 13.9 | 14.0 | signal |
| 6 | Aspartate Aminotransferase Increased | 54 | 13.0 | 13.4 | signal |
| 7 | Dermatitis Allergic | 11 | 11.3 | 11.3 | signal |
| 8 | Drug Ineffective For Unapproved Indication | 48 | 11.0 | 11.3 | signal |
| 9 | Deafness | 22 | 10.7 | 10.9 | signal |
| 10 | Alanine Aminotransferase Increased | 46 | 9.6 | 9.8 | signal |
| 11 | Skin Discolouration | 34 | 9.5 | 9.6 | signal |
| 12 | Blood Bilirubin Increased | 20 | 9.4 | 9.5 | signal |
| 13 | Tinnitus | 32 | 8.9 | 9.0 | signal |
| 14 | Haemoptysis | 19 | 8.7 | 8.8 | signal |
| 15 | Sputum Discoloured | 6 | 8.1 | 8.1 | signal |
| 16 | Blood Alkaline Phosphatase Increased | 15 | 7.7 | 7.8 | signal |
| 17 | Aphonia | 8 | 7.3 | 7.4 | signal |
| 18 | Drug Eruption | 10 | 7.2 | 7.3 | signal |
| 19 | Poor Quality Sleep | 12 | 7.2 | 7.2 | signal |
| 20 | Osteomyelitis | 10 | 7.1 | 7.1 | signal |
| 21 | Off Label Use | 437 | 6.4 | 8.4 | signal |
| 22 | Secretion Discharge | 6 | 6.2 | 6.2 | signal |
| 23 | Therapy Interrupted | 33 | 6.1 | 6.2 | signal |
| 24 | Skin Lesion | 13 | 6.1 | 6.1 | signal |
| 25 | Transaminases Increased | 10 | 5.8 | 5.8 | signal |
| 26 | Internal Haemorrhage | 5 | 5.6 | 5.6 | signal |
| 27 | Dysphonia | 25 | 5.5 | 5.5 | signal |
| 28 | Rash Erythematous | 19 | 5.2 | 5.2 | signal |
| 29 | Insurance Issue | 6 | 5.2 | 5.2 | signal |
| 30 | Eosinophilia | 7 | 5.1 | 5.1 | signal |
| 31 | Hospitalisation | 59 | 4.9 | 5.1 | signal |
| 32 | Respiratory Tract Congestion | 6 | 4.8 | 4.8 | signal |
| 33 | Unevaluable Event | 28 | 4.7 | 4.8 | signal |
| 34 | Cholestasis | 7 | 4.7 | 4.7 | signal |
| 35 | Intentional Dose Omission | 10 | 4.7 | 4.7 | signal |
| 36 | Eye Inflammation | 3 | 4.1 | 4.1 | signal |
| 37 | Incorrect Dose Administered | 68 | 3.9 | 4.0 | signal |
| 38 | Drug Level Decreased | 3 | 3.7 | 3.8 | no signal |
| 39 | Accidental Underdose | 3 | 2.6 | 2.6 | no signal |
| 40 | Sickle Cell Anaemia With Crisis | 3 | 2.4 | 2.4 | no signal |
| 41 | Myelosuppression | 4 | 1.5 | 1.5 | no signal |
| 42 | Drug Dose Omission By Device | 5 | 0.8 | 0.8 | no signal |