Drug
Promethazine Hydrochloride And Codeine Phosphate
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 | Dependence | 3,495 | 395.8 | 21,956.3 | signal |
| 2 | Back Injury | 238 | 132.4 | 141.8 | signal |
| 3 | Spinal Operation | 77 | 37.7 | 38.5 | signal |
| 4 | Knee Operation | 34 | 20.7 | 20.9 | signal |
| 5 | Overdose | 680 | 18.6 | 22.7 | signal |
| 6 | Intervertebral Disc Degeneration | 27 | 17.1 | 17.3 | signal |
| 7 | Joint Injury | 48 | 13.3 | 13.4 | signal |
| 8 | Intervertebral Disc Protrusion | 48 | 12.9 | 13.1 | signal |
| 9 | Road Traffic Accident | 84 | 11.8 | 12.1 | signal |
| 10 | Back Pain | 420 | 10.7 | 12.0 | signal |
| 11 | Drug Withdrawal Syndrome Neonatal | 24 | 9.5 | 9.5 | signal |
| 12 | Ill-defined Disorder | 78 | 7.6 | 7.7 | signal |
| 13 | Limb Injury | 34 | 7.4 | 7.5 | signal |
| 14 | Neck Pain | 65 | 6.9 | 7.0 | signal |
| 15 | Withdrawal Syndrome | 46 | 6.4 | 6.5 | signal |
| 16 | Fibromyalgia | 26 | 6.3 | 6.4 | signal |
| 17 | Spinal Fracture | 21 | 6.2 | 6.2 | signal |
| 18 | Rotator Cuff Syndrome | 13 | 5.9 | 6.0 | signal |
| 19 | Toothache | 17 | 5.5 | 5.6 | signal |
| 20 | Caesarean Section | 11 | 5.5 | 5.5 | signal |
| 21 | Brain Injury | 9 | 5.3 | 5.3 | signal |
| 22 | Knee Arthroplasty | 15 | 4.2 | 4.3 | signal |
| 23 | Ankle Fracture | 11 | 4.2 | 4.2 | signal |
| 24 | Hip Arthroplasty | 10 | 3.9 | 3.9 | signal |
| 25 | Nerve Injury | 7 | 3.7 | 3.7 | signal |
| 26 | Carpal Tunnel Syndrome | 8 | 3.4 | 3.4 | signal |
| 27 | Product Prescribing Issue | 11 | 3.2 | 3.2 | signal |
| 28 | Tooth Disorder | 12 | 3.2 | 3.2 | signal |
| 29 | Fracture | 10 | 3.1 | 3.1 | signal |
| 30 | Lower Limb Fracture | 10 | 3.1 | 3.1 | signal |
| 31 | Arthritis | 37 | 2.8 | 2.8 | signal |
| 32 | Disability | 9 | 2.7 | 2.7 | signal |
| 33 | Injury | 29 | 2.4 | 2.4 | signal |
| 34 | Hepatitis C | 4 | 1.9 | 1.9 | no signal |
| 35 | Brain Neoplasm | 3 | 1.9 | 1.9 | no signal |
| 36 | Surgery | 18 | 1.8 | 1.8 | no signal |
| 37 | Foetal Exposure During Pregnancy | 25 | 1.8 | 1.8 | no signal |
| 38 | Euphoric Mood | 3 | 1.7 | 1.7 | no signal |
| 39 | Sexual Dysfunction | 3 | 1.5 | 1.5 | no signal |
| 40 | Respiratory Depression | 3 | 1.4 | 1.4 | no signal |
| 41 | Dysmenorrhoea | 3 | 1.4 | 1.4 | no signal |
| 42 | Drug Abuse | 8 | 0.6 | 0.6 | no signal |