Drug
Famotidine Tablet, Film-coated
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 | End Stage Renal Disease | 89 | 18.4 | 18.7 | signal |
| 2 | Chronic Kidney Disease | 342 | 17.0 | 18.1 | signal |
| 3 | Exposure During Pregnancy | 267 | 16.4 | 17.1 | signal |
| 4 | Accidental Overdose | 111 | 11.6 | 11.8 | signal |
| 5 | Faeces Discoloured | 62 | 10.9 | 11.0 | signal |
| 6 | Impaired Quality Of Life | 41 | 10.8 | 10.9 | signal |
| 7 | Dyspepsia | 227 | 8.8 | 9.1 | signal |
| 8 | Eructation | 41 | 8.2 | 8.2 | signal |
| 9 | Colon Cancer | 24 | 6.1 | 6.1 | signal |
| 10 | Tubulointerstitial Nephritis | 30 | 6.1 | 6.1 | signal |
| 11 | Gastrooesophageal Reflux Disease | 127 | 6.0 | 6.1 | signal |
| 12 | Renal Injury | 44 | 5.6 | 5.6 | signal |
| 13 | Injury | 102 | 5.5 | 5.6 | signal |
| 14 | Flatulence | 75 | 5.0 | 5.1 | signal |
| 15 | Gastric Cancer | 30 | 4.4 | 4.5 | signal |
| 16 | Pruritus Generalised | 24 | 4.2 | 4.2 | signal |
| 17 | Acute Kidney Injury | 166 | 4.1 | 4.2 | signal |
| 18 | Incorrect Drug Administration Duration | 31 | 4.1 | 4.1 | signal |
| 19 | Renal Failure | 143 | 4.1 | 4.1 | signal |
| 20 | Renal Cancer | 51 | 4.0 | 4.0 | signal |
| 21 | Neoplasm Malignant | 66 | 3.8 | 3.8 | signal |
| 22 | Chromaturia | 21 | 3.5 | 3.5 | signal |
| 23 | Anorexia | 12 | 3.5 | 3.5 | signal |
| 24 | Anhedonia | 24 | 3.4 | 3.5 | signal |
| 25 | Bladder Cancer | 53 | 3.4 | 3.4 | signal |
| 26 | Oesophageal Carcinoma | 26 | 3.3 | 3.3 | signal |
| 27 | Nephropathy | 8 | 3.2 | 3.2 | signal |
| 28 | Rebound Effect | 9 | 3.0 | 3.0 | signal |
| 29 | Drug Ineffective | 1,038 | 3.0 | 3.5 | signal |
| 30 | Feeling Jittery | 15 | 3.0 | 3.0 | signal |
| 31 | Hiatus Hernia | 10 | 2.9 | 2.9 | signal |
| 32 | Pancreatic Carcinoma | 22 | 2.9 | 2.9 | signal |
| 33 | Product Packaging Issue | 7 | 2.9 | 2.9 | signal |
| 34 | Deformity | 7 | 2.8 | 2.8 | signal |
| 35 | Economic Problem | 11 | 2.7 | 2.7 | signal |
| 36 | Throat Tightness | 19 | 2.7 | 2.7 | signal |
| 37 | Abdominal Pain Upper | 144 | 2.7 | 2.7 | signal |
| 38 | Therapeutic Response Decreased | 41 | 2.6 | 2.6 | signal |
| 39 | Unevaluable Event | 51 | 2.6 | 2.6 | signal |
| 40 | Drug Effect Decreased | 36 | 2.5 | 2.5 | signal |
| 41 | Anxiety | 186 | 2.5 | 2.5 | signal |
| 42 | Pharyngeal Oedema | 10 | 2.4 | 2.4 | signal |
| 43 | Leukaemia | 6 | 2.4 | 2.4 | no signal |
| 44 | Dysgeusia | 47 | 2.4 | 2.4 | signal |
| 45 | Throat Irritation | 28 | 2.4 | 2.4 | signal |
| 46 | Emotional Distress | 76 | 2.4 | 2.4 | signal |
| 47 | Coeliac Disease | 6 | 2.3 | 2.3 | no signal |
| 48 | Rash Generalised | 16 | 2.3 | 2.3 | signal |
| 49 | Colorectal Cancer | 28 | 2.2 | 2.2 | signal |
| 50 | Oral Discomfort | 8 | 2.2 | 2.2 | signal |
| 51 | Lip Swelling | 19 | 2.2 | 2.2 | signal |
| 52 | Intentional Drug Misuse | 12 | 2.1 | 2.1 | signal |
| 53 | Ulcer | 9 | 2.1 | 2.1 | signal |
| 54 | Wrong Technique In Drug Usage Process | 20 | 2.1 | 2.1 | signal |
| 55 | Prostate Cancer | 44 | 2.1 | 2.1 | signal |
| 56 | Hepatic Cancer | 13 | 2.0 | 2.0 | signal |
| 57 | Product Taste Abnormal | 7 | 2.0 | 2.0 | no signal |
| 58 | Nervousness | 27 | 2.0 | 2.0 | no signal |
| 59 | Salivary Hypersecretion | 5 | 1.9 | 1.9 | no signal |
| 60 | Dry Throat | 5 | 1.9 | 1.9 | no signal |
| 61 | Glossodynia | 11 | 1.9 | 1.9 | no signal |
| 62 | Medication Error | 27 | 1.8 | 1.9 | no signal |
| 63 | Drug Administration Error | 15 | 1.8 | 1.8 | no signal |
| 64 | Impaired Work Ability | 10 | 1.8 | 1.8 | no signal |
| 65 | Drug Dispensing Error | 7 | 1.7 | 1.7 | no signal |
| 66 | Frequent Bowel Movements | 12 | 1.7 | 1.7 | no signal |
| 67 | Disability | 8 | 1.5 | 1.5 | no signal |
| 68 | Product Administration Error | 8 | 1.5 | 1.5 | no signal |
| 69 | Cold Sweat | 7 | 1.5 | 1.5 | no signal |
| 70 | Heart Rate Irregular | 9 | 1.5 | 1.5 | no signal |
| 71 | Incorrect Product Administration Duration | 8 | 1.5 | 1.5 | no signal |
| 72 | Gastric Disorder | 13 | 1.4 | 1.4 | no signal |
| 73 | Burning Sensation | 26 | 1.4 | 1.4 | no signal |
| 74 | Abnormal Dreams | 10 | 1.4 | 1.4 | no signal |
| 75 | Sneezing | 8 | 1.4 | 1.4 | no signal |
| 76 | Breast Cancer Female | 9 | 1.3 | 1.3 | no signal |
| 77 | Thyroid Cancer | 4 | 1.3 | 1.3 | no signal |
| 78 | Gastrointestinal Carcinoma | 3 | 1.2 | 1.2 | no signal |
| 79 | Extra Dose Administered | 13 | 1.2 | 1.2 | no signal |
| 80 | Ovarian Cancer | 3 | 1.2 | 1.2 | no signal |
| 81 | No Therapeutic Response | 4 | 1.2 | 1.2 | no signal |
| 82 | Overdose | 70 | 1.2 | 1.2 | no signal |
| 83 | Tooth Extraction | 4 | 1.2 | 1.2 | no signal |
| 84 | Grand Mal Convulsion | 3 | 1.2 | 1.2 | no signal |
| 85 | Increased Appetite | 6 | 1.2 | 1.2 | no signal |
| 86 | Product Availability Issue | 7 | 1.2 | 1.2 | no signal |
| 87 | Mydriasis | 4 | 1.2 | 1.2 | no signal |
| 88 | Pharmaceutical Product Complaint | 8 | 1.2 | 1.2 | no signal |
| 89 | Eye Pruritus | 10 | 1.2 | 1.2 | no signal |
| 90 | Expired Product Administered | 10 | 1.1 | 1.1 | no signal |
| 91 | Vaginal Discharge | 3 | 1.1 | 1.1 | no signal |
| 92 | Drug Toxicity | 4 | 1.1 | 1.1 | no signal |
| 93 | No Adverse Event | 51 | 1.1 | 1.1 | no signal |
| 94 | Bipolar Disorder | 3 | 1.0 | 1.0 | no signal |
| 95 | Incorrect Dose Administered | 59 | 1.0 | 1.0 | no signal |
| 96 | Breast Cancer | 21 | 0.8 | 0.8 | no signal |
| 97 | Drug Exposure During Pregnancy | 7 | 0.8 | 0.8 | no signal |
| 98 | Lung Neoplasm Malignant | 8 | 0.7 | 0.7 | no signal |
| 99 | Product Substitution Issue | 11 | 0.7 | 0.7 | no signal |
| 100 | Menorrhagia | 3 | 0.6 | 0.6 | no signal |
| 101 | Multiple Sclerosis | 6 | 0.5 | 0.5 | no signal |
| 102 | Drug Withdrawal Syndrome | 7 | 0.3 | 0.3 | no signal |
| 103 | Drug Dependence | 9 | 0.2 | 0.2 | no signal |