Drug
Amlodipine Besylate And Olmesartan Medoxomil
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 | Hiatus Hernia | 93 | 60.5 | 62.7 | signal |
| 2 | Haemorrhoids | 133 | 57.4 | 60.5 | signal |
| 3 | Coeliac Disease | 32 | 27.4 | 27.7 | signal |
| 4 | Irritable Bowel Syndrome | 67 | 26.3 | 27.0 | signal |
| 5 | Diverticulitis | 75 | 22.8 | 23.5 | signal |
| 6 | Gastrooesophageal Reflux Disease | 210 | 22.0 | 23.9 | signal |
| 7 | Gastric Ulcer | 40 | 17.6 | 17.9 | signal |
| 8 | Helicobacter Infection | 17 | 14.0 | 14.1 | signal |
| 9 | Chronic Kidney Disease | 126 | 13.8 | 14.5 | signal |
| 10 | End Stage Renal Disease | 30 | 13.7 | 13.8 | signal |
| 11 | Product Administration Error | 31 | 13.0 | 13.2 | signal |
| 12 | Cholecystitis | 16 | 11.3 | 11.4 | signal |
| 13 | Cholelithiasis | 43 | 11.0 | 11.2 | signal |
| 14 | Gastroenteritis | 18 | 10.4 | 10.4 | signal |
| 15 | Clostridium Difficile Colitis | 13 | 10.3 | 10.3 | signal |
| 16 | Small Intestinal Obstruction | 15 | 10.2 | 10.3 | signal |
| 17 | Impaired Gastric Emptying | 15 | 9.9 | 9.9 | signal |
| 18 | Acute Kidney Injury | 169 | 9.3 | 9.9 | signal |
| 19 | Drug Administration Error | 31 | 8.3 | 8.4 | signal |
| 20 | Gastroenteritis Viral | 17 | 7.9 | 7.9 | signal |
| 21 | Flushing | 93 | 7.6 | 7.9 | signal |
| 22 | Gastritis | 23 | 7.3 | 7.4 | signal |
| 23 | Cholecystectomy | 9 | 6.6 | 6.7 | signal |
| 24 | Madarosis | 9 | 6.4 | 6.5 | signal |
| 25 | Iron Deficiency Anaemia | 7 | 6.4 | 6.4 | signal |
| 26 | Tubulointerstitial Nephritis | 14 | 6.3 | 6.3 | signal |
| 27 | Ileus | 9 | 6.1 | 6.1 | signal |
| 28 | Rectal Haemorrhage | 31 | 6.0 | 6.1 | signal |
| 29 | Vitamin D Deficiency | 7 | 6.0 | 6.0 | signal |
| 30 | Pancreatitis Acute | 15 | 5.6 | 5.7 | signal |
| 31 | Renal Injury | 20 | 5.6 | 5.6 | signal |
| 32 | Oedema Peripheral | 80 | 5.5 | 5.6 | signal |
| 33 | Body Height Decreased | 7 | 5.4 | 5.4 | signal |
| 34 | Hepatic Steatosis | 12 | 5.4 | 5.4 | signal |
| 35 | Nephropathy | 6 | 5.4 | 5.4 | signal |
| 36 | Renal Failure | 83 | 5.2 | 5.3 | signal |
| 37 | Syncope | 61 | 5.1 | 5.2 | signal |
| 38 | Weight Decreased | 167 | 5.0 | 5.3 | signal |
| 39 | Gastrointestinal Haemorrhage | 49 | 4.9 | 5.0 | signal |
| 40 | Oesophagitis | 6 | 4.6 | 4.6 | signal |
| 41 | Pulmonary Mass | 8 | 4.5 | 4.5 | signal |
| 42 | Upper Gastrointestinal Haemorrhage | 9 | 4.5 | 4.5 | signal |
| 43 | Spinal Disorder | 5 | 4.4 | 4.4 | signal |
| 44 | Hair Texture Abnormal | 7 | 4.3 | 4.4 | signal |
| 45 | Sinus Bradycardia | 5 | 4.3 | 4.3 | signal |
| 46 | Inflammatory Bowel Disease | 5 | 4.3 | 4.3 | signal |
| 47 | Gout | 9 | 4.2 | 4.2 | signal |
| 48 | Haematochezia | 27 | 4.1 | 4.1 | signal |
| 49 | Temperature Intolerance | 5 | 4.1 | 4.1 | signal |
| 50 | Hair Colour Changes | 6 | 4.0 | 4.0 | signal |
| 51 | Colon Cancer | 7 | 3.9 | 3.9 | signal |
| 52 | Feeling Hot | 28 | 3.8 | 3.9 | signal |
| 53 | Local Swelling | 8 | 3.8 | 3.8 | signal |
| 54 | Peripheral Coldness | 6 | 3.6 | 3.7 | signal |
| 55 | Diarrhoea Haemorrhagic | 4 | 3.6 | 3.6 | signal |
| 56 | Thyroid Cancer | 5 | 3.5 | 3.5 | signal |
| 57 | Knee Operation | 4 | 3.5 | 3.5 | signal |
| 58 | No Therapeutic Response | 5 | 3.4 | 3.4 | signal |
| 59 | Tooth Extraction | 5 | 3.4 | 3.4 | signal |
| 60 | Coronary Artery Disease | 12 | 3.3 | 3.3 | signal |
| 61 | Economic Problem | 6 | 3.3 | 3.3 | signal |
| 62 | Middle Insomnia | 7 | 3.2 | 3.2 | signal |
| 63 | Blood Pressure Fluctuation | 9 | 3.1 | 3.1 | signal |
| 64 | Nerve Injury | 4 | 3.0 | 3.0 | no signal |
| 65 | Hypertensive Crisis | 4 | 3.0 | 3.0 | no signal |
| 66 | Blindness Unilateral | 5 | 3.0 | 3.0 | signal |
| 67 | Activities Of Daily Living Impaired | 7 | 2.9 | 2.9 | signal |
| 68 | Spinal Pain | 4 | 2.9 | 2.9 | no signal |
| 69 | Knee Arthroplasty | 7 | 2.8 | 2.8 | signal |
| 70 | Nerve Compression | 3 | 2.7 | 2.7 | no signal |
| 71 | Increased Appetite | 6 | 2.7 | 2.7 | signal |
| 72 | Pruritus Generalised | 7 | 2.7 | 2.7 | signal |
| 73 | Feeling Jittery | 6 | 2.6 | 2.6 | signal |
| 74 | Erectile Dysfunction | 8 | 2.6 | 2.6 | signal |
| 75 | Palmar-plantar Erythrodysaesthesia Syndrome | 7 | 2.5 | 2.5 | signal |
| 76 | Scratch | 3 | 2.4 | 2.4 | no signal |
| 77 | Prostatic Specific Antigen Increased | 4 | 2.4 | 2.4 | no signal |
| 78 | Impaired Driving Ability | 3 | 2.2 | 2.2 | no signal |
| 79 | Spinal Operation | 3 | 2.1 | 2.1 | no signal |
| 80 | Wrong Technique In Drug Usage Process | 9 | 2.0 | 2.0 | no signal |
| 81 | Libido Decreased | 3 | 2.0 | 2.0 | no signal |
| 82 | Injection Site Discolouration | 3 | 2.0 | 2.0 | no signal |
| 83 | Intraocular Pressure Increased | 3 | 2.0 | 2.0 | no signal |
| 84 | Abnormal Dreams | 6 | 1.8 | 1.8 | no signal |
| 85 | Injection Site Haematoma | 3 | 1.7 | 1.7 | no signal |
| 86 | Colitis Ulcerative | 9 | 1.7 | 1.7 | no signal |
| 87 | Drug Dispensing Error | 3 | 1.6 | 1.6 | no signal |
| 88 | Drug Dose Omission | 32 | 1.6 | 1.6 | no signal |
| 89 | Skin Burning Sensation | 13 | 1.5 | 1.5 | no signal |
| 90 | Application Site Pain | 4 | 1.5 | 1.5 | no signal |
| 91 | Inappropriate Schedule Of Drug Administration | 12 | 1.4 | 1.4 | no signal |
| 92 | Glycosylated Haemoglobin Increased | 4 | 1.3 | 1.3 | no signal |
| 93 | Drug Prescribing Error | 3 | 1.3 | 1.3 | no signal |
| 94 | Intentional Drug Misuse | 3 | 1.2 | 1.2 | no signal |
| 95 | Incorrect Route Of Drug Administration | 5 | 1.2 | 1.2 | no signal |
| 96 | Injection Site Haemorrhage | 9 | 0.9 | 0.9 | no signal |
| 97 | Breast Cancer Female | 3 | 0.9 | 0.9 | no signal |
| 98 | Device Malfunction | 7 | 0.9 | 0.9 | no signal |
| 99 | Renal Cancer | 5 | 0.9 | 0.9 | no signal |
| 100 | Bladder Cancer | 4 | 0.6 | 0.6 | no signal |