Summary of published case reports of ranitidine hepatoxicity
Blank entries indicate no report in the cited reference.
| Reference | Patient Information | Clinical Chemistry | Biopsy (Inflammation) | Prodromal Inflammatory Signs | Rechallenge (Result) | Concurrent Ethanol | Viral Hepatitis | Autoantibodies | Other Underlying Disease | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age | Gender | Onset | ALT | AST | ALP | GGT | Bilirubin | ||||||||
| years | U/l | U/l | U/l | U/l | mg/dl | ||||||||||
| Barr and Piper, 1981 | 63 | F | 2 wk | 870 | 705 | 470 | 16 | No | No | Hep A (IgG, No IgM) | Positive sm. muscle Ab (1:20) | Duodenal ulcer | |||
| Black et al., 1984 | 63 | M | 3 wk | 207 | 157 | 152 | 164 | 0.7 | No | No | Negative | Ulcer | |||
| Black et al., 1984 | 59 | F | 3 wk | 89 | 65 | 724 | 2.1 | No | inf,f | No | Negative | Ulcer | |||
| Black et al., 1984 | 19 | F | 4 wk | 100 | 167 | 148 | 8.8 | No | f,n | No | Negative | Diabetes, ulcer | |||
| Bredfeldt, 1984 | 42 | M | 3 wk | 196 | 708 | 2.1 | No | No | Negative | Duodenal ulcer | |||||
| Cohen and Fabre, 1983 (CT) | M | 239 | 109 | No | Negative | ||||||||||
| Colin-Jones et al., 1984 | 51 | F | 2 wk | 85 | 290 | 3.6 | Yes (no) | No | No | ||||||
| Desaint et al., 1985 (T) | 27 | M | 2 wk | 1100 | 830 | 205 | 17 | 22 | Yes (yes) | No | No | Negative | Negative | ||
| Devuyst et al., 1993 | 58 | M | 2 wk | 398 | 305 | 398 | 520 | 4.4 | No | n | No | No | Negative | Negative | |
| Graham et al., 1985 | 50 | M | 6 wk | 185 | 203 | 1680 | 2.6 | Yes (no injury) | Negative | Gastric ulcer | |||||
| Halparin, 1984 | 62 | F | 8 mo | 225 | 427 | 1218 | 26 | Yes (yes) | m,ap,d | No | Yes | Hep A (IgG, No IgM) | Duodenal ulcer | ||
| Hiesse et al., 1985 | 38 | M | 1 wk | 530 | 100 | 84 | 3.5 | Yes (yes) | Yes (repeat injury) | Negative | Negative | Kidney transplant | |||
| Hirschowitz et al., 1986 | 70 | M | 4 wk | 349 | 131 | 130 | Yes (yes) | Negative | Duodenal ulcer | ||||||
| Jones et al., 1982 (CT) | 2 wk | 54 | No | Yes | |||||||||||
| Jones et al., 1982 (CT) | 4 wk | 45 | No | No | |||||||||||
| Jones et al., 1982 (CT) | 4 wk | 196 | 159 | ||||||||||||
| Kantarceken et al., 2006 | 39 | F | 2 days | 1153 | 742 | 88 | 196 | 3.7 | No | ap | No | GERD | |||
| Karachalios, 1985 | 65 | M | 3 wk | 920 | 145 | 11.9 | Yes (yes) | f | No | Negative | Negative | ||||
| Lauritsen et al., 1984 | 81 | M | 6 wk | 650 | 724 | 16 | Yes (yes) | No | No | Hep A (IgG, No IgM) | Negative | Ulcer | |||
| Lee et al., 1986 | 60 | M | 4 wk | 287 | 61 | ||||||||||
| Lee et al., 1986 | 34 | M | 4 wk | 57 | 1.3 | ||||||||||
| Lee et al., 1986 | 82 | M | 4 wk | 220 | 3 | ||||||||||
| Liberopoulos et al., 2002 | 73 | F | 3 wk | 78 | 76 | 299 | 15.6 | Yes (yes) | No | No | No | Negative | Negative | ||
| Luparini et al., 2000 (T) | 46 | F | 2739 | 1167 | 90 | 107 | 3 | Yes (yes) | Yes | Yes (repeat injury) | Yes | Negative | Multiple sclerosis | ||
| Offit and Sojka, 1984 | 66 | M | 5 wk | 145 | 128 | 466 | 535 | Yes (yes) | f,m | No | Chronic ulcer | ||||
| Proctor, 1984 | 50 | F | 2 wk | 304 | 87 | 209 | 1.3 | m,n,ap | No | Negative | GERD, hiatal hernia | ||||
| Ramrakhiani et al., 1998 | 29 | M | 2 wk | 51 | 43 | 10–30 | Yes (yes) | No | No | Negative | Negative | GERD | |||
| Ribeiro et al., 2000 (fatal) | 66 | F | 1–3 wk | 1020 | 1000 | 150 | 588 | 11.4 | Yes (yes) | No | Negative | Negative | Flu/dyspepsia | ||
| Souza Lima, 1984 | 77 | F | 2 wk | 132 | 430 | 384 | 0.3 | Yes (yes) | f,n | No | Negative | Negative | |||
| Valois et al., 2003 | 51 | M | 2–3 wk | 1457 | 819 | 13 | Yes (yes) | f, | No | Yes | Negative | Negative | Protein S-deficiency | ||
| van Bommel and Meyboom, 1992 (T) | 69 | F | 3 wk | 710 | 387 | 104 | 317 | 5 | m,la,ap,n | No | Negative | Negative | |||
| van Bommel and Meyboom, 1992 (T) | 43 | M | 3 mo | 354 | 88 | 600 | 954 | 12 | f,m,la,ap,n | Yes (repeat injury) | Negative | ||||
| van Bommel and Meyboom, 1992 (T) | 49 | F | 1 wk | 930 | 425 | 322 | 454 | 6 | m,la,ap | Negative | |||||
| van Bommel and Meyboom, 1992 (T) | 64 | M | 3 wk | 321 | 91 | 197 | 356 | 1 | m,la | Negative | |||||
| van Bommel and Meyboom, 1992 (T) | 61 | M | 3 wk | 267 | 195 | 222 | 822 | 2 | f,m,la,ap,n | Yes (repeat injury) | Negative | Negative | |||
| van Bommel and Meyboom, 1992 (T) | 61 | M | 5 wk | 1150 | 940 | 433 | 1 | m,la,n | Negative | Negative | |||||
| Varriale et al., 2004 | 79 | M | 3 wk | 75 | 55 | 891 | 38 | 22.4 | Yes (yes) | ap | No | No | Negative | Negative | Epigastric pain |
CT, results were observed during a clinical trial; T, original article not in English (where translation not possible, entries are left blank); F, fatal, mortality associated with ranitidine treatment; wk, week(s); mo, month(s); ALT, alanine aminotransferase; ALP, alkaline phosphatase; AST, aspartate aminotransferase; GGT, γ-glutamyltransferase; f, fever; m, malaise; la, loss of appetite; ap, abdominal pain; n, nausea/vomiting; d, diarrhea; inf, infection; GERD, gastroesophageal reflux disease.