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Drug

Acetaminophen And Codeine Phosphate

126 flagged reaction(s) · 1,575 total co-reports · max PRR 22.6
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 Drug Toxicity 28 22.6 22.9 signal
2 Liver Function Test Abnormal 39 14.8 15.1 signal
3 Completed Suicide 100 13.2 13.9 signal
4 Haematemesis 29 12.7 12.9 signal
5 Poisoning 14 12.3 12.4 signal
6 Renal Failure Acute 43 11.1 11.3 signal
7 Pulmonary Fibrosis 17 9.9 10.0 signal
8 Acute Hepatic Failure 12 9.8 9.9 signal
9 Circulatory Collapse 15 9.7 9.8 signal
10 International Normalised Ratio Increased 25 9.7 9.8 signal
11 Glomerular Filtration Rate Decreased 10 9.2 9.2 signal
12 Melaena 18 9.1 9.1 signal
13 Toxic Epidermal Necrolysis 12 8.8 8.9 signal
14 Toxic Skin Eruption 8 8.8 8.8 signal
15 Myocardial Ischaemia 9 8.7 8.8 signal
16 Tenderness 8 8.5 8.5 signal
17 Hyperlipidaemia 9 8.3 8.4 signal
18 Rhabdomyolysis 31 8.3 8.4 signal
19 Gastric Ulcer 14 8.2 8.2 signal
20 Gamma-glutamyltransferase Increased 16 8.0 8.1 signal
21 Intentional Drug Misuse 15 7.9 7.9 signal
22 Multi-organ Failure 12 7.6 7.6 signal
23 Iron Deficiency Anaemia 6 7.3 7.3 signal
24 Respiratory Depression 8 7.2 7.3 signal
25 Blood Alkaline Phosphatase Increased 16 7.1 7.2 signal
26 Hepatic Encephalopathy 6 7.1 7.2 signal
27 Acute Myocardial Infarction 19 7.1 7.2 signal
28 Jaundice 17 7.0 7.1 signal
29 Blood Creatine Phosphokinase Increased 18 6.8 6.9 signal
30 Respiratory Arrest 17 6.8 6.8 signal
31 Fluid Overload 9 6.8 6.8 signal
32 Hypotonia 6 6.6 6.7 signal
33 Cardio-respiratory Arrest 25 6.6 6.7 signal
34 Upper Gastrointestinal Haemorrhage 10 6.6 6.6 signal
35 Skin Reaction 8 6.3 6.3 signal
36 Sudden Death 6 6.2 6.3 signal
37 Depressed Level Of Consciousness 22 6.2 6.3 signal
38 Gastrointestinal Haemorrhage 46 6.1 6.2 signal
39 Hyperkalaemia 19 6.0 6.1 signal
40 Unresponsive To Stimuli 14 6.0 6.1 signal
41 Platelet Count Increased 7 6.0 6.0 signal
42 Hepatic Failure 16 5.9 5.9 signal
43 Pallor 14 5.7 5.7 signal
44 Swollen Tongue 16 5.7 5.7 signal
45 Metabolic Acidosis 16 5.6 5.7 signal
46 Thirst 9 5.6 5.6 signal
47 Macular Degeneration 6 5.6 5.6 signal
48 Gout 9 5.6 5.6 signal
49 Mass 7 5.5 5.6 signal
50 Coronary Artery Disease 15 5.5 5.5 signal
51 Cerebral Infarction 12 5.5 5.5 signal
52 Neutrophil Count Increased 5 5.4 5.4 signal
53 Hypokinesia 7 5.4 5.4 signal
54 Lip Swelling 16 5.3 5.4 signal
55 Mouth Ulceration 10 5.3 5.3 signal
56 Urinary Incontinence 14 5.3 5.3 signal
57 Medication Error 26 5.2 5.3 signal
58 Haemoglobin Decreased 48 5.2 5.3 signal
59 Drug Exposure During Pregnancy 16 5.2 5.2 signal
60 Rash Generalised 12 5.1 5.1 signal
61 Cyanosis 7 4.9 4.9 signal
62 Lower Respiratory Tract Infection 20 4.9 4.9 signal
63 Scab 5 4.9 4.9 signal
64 Cardiovascular Disorder 11 4.8 4.8 signal
65 Poisoning Deliberate 4 4.8 4.8 signal
66 Vasculitis 5 4.8 4.8 signal
67 Erectile Dysfunction 11 4.7 4.8 signal
68 Caesarean Section 5 4.7 4.7 signal
69 Bronchospasm 6 4.7 4.7 signal
70 Dizziness Postural 4 4.6 4.6 signal
71 Angina Pectoris 12 4.6 4.6 signal
72 Pancreatitis 22 4.6 4.7 signal
73 Faeces Discoloured 9 4.6 4.6 signal
74 Parkinsonism 4 4.6 4.6 signal
75 Stevens-johnson Syndrome 9 4.5 4.5 signal
76 Pancreatitis Acute 9 4.5 4.5 signal
77 Anaphylactic Reaction 22 4.4 4.5 signal
78 Chromaturia 9 4.4 4.4 signal
79 Cholestasis 7 4.1 4.1 signal
80 Red Blood Cell Sedimentation Rate Increased 4 4.0 4.0 signal
81 Eosinophilia 6 3.8 3.8 signal
82 Eyelid Oedema 4 3.8 3.8 signal
83 Myoclonus 4 3.7 3.7 signal
84 Hallucination, Visual 7 3.7 3.7 signal
85 Delusion 5 3.6 3.6 signal
86 Drug Dispensing Error 5 3.6 3.6 signal
87 Erythema Multiforme 3 3.6 3.6 no signal
88 Drug Administration Error 10 3.6 3.6 signal
89 Diarrhoea Haemorrhagic 3 3.6 3.6 no signal
90 Angioedema 14 3.5 3.5 signal
91 Convulsion 18 3.4 3.5 signal
92 Ankylosing Spondylitis 4 3.4 3.4 signal
93 Sopor 4 3.3 3.3 signal
94 Pregnancy 6 3.3 3.3 signal
95 Helicobacter Infection 3 3.3 3.3 no signal
96 Lymphopenia 4 3.2 3.2 no signal
97 Irritability 17 3.1 3.2 signal
98 Aggression 14 3.1 3.1 signal
99 Extrapyramidal Disorder 7 3.1 3.1 signal
100 Pharyngitis Streptococcal 3 3.1 3.1 no signal
101 Pelvic Pain 5 3.1 3.1 signal
102 Psychotic Disorder 8 3.0 3.0 signal
103 Drug Abuse 22 2.9 2.9 signal
104 Myocardial Infarction 46 2.9 3.0 signal
105 Metastases To Lung 3 2.9 2.9 no signal
106 Dependence 14 2.8 2.8 signal
107 Abnormal Behaviour 10 2.8 2.8 signal
108 Activities Of Daily Living Impaired 5 2.8 2.8 signal
109 Thyroid Cancer 3 2.8 2.8 no signal
110 Mania 4 2.7 2.7 no signal
111 Libido Decreased 3 2.7 2.7 no signal
112 Osteonecrosis 8 2.7 2.7 signal
113 Abasia 6 2.7 2.7 signal
114 Tuberculosis 3 2.6 2.6 no signal
115 Anorexia 3 2.5 2.6 no signal
116 Hepatocellular Injury 3 2.3 2.3 no signal
117 Withdrawal Syndrome 8 2.1 2.1 no signal
118 Tardive Dyskinesia 5 1.9 2.0 no signal
119 Suicide Attempt 10 1.8 1.8 no signal
120 Intentional Overdose 10 1.7 1.7 no signal
121 Dystonia 3 1.7 1.7 no signal
122 Abortion Spontaneous 6 1.7 1.7 no signal
123 Pancreatic Carcinoma 3 1.1 1.1 no signal
124 Oesophageal Carcinoma 3 1.1 1.1 no signal
125 Drug Withdrawal Syndrome 7 0.9 0.9 no signal
126 Drug Dependence 11 0.8 0.7 no signal