What the label lists and what reports show
Amoxicillin and omeprazole and rifabutin side effects
Amoxicillin and omeprazole and rifabutin's FDA label: “Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.” FAERS holds 219 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (25 reports).
- No generic listed
Check it at the source: the amoxicillin and omeprazole and rifabutin FDA label on DailyMed (effective December 23, 2025, RedHill Biopharma Ltd); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | TALICIA (N=228) n (%) | Amoxicillin and Omeprazole (N=227) n (%) | TALICIA (N=77) n (%) | Placebo (N=41) n (%) |
|---|---|---|---|---|
| Diarrhea | 23 (10.1) | 18 (7.9) | 11 (14.3) | 4 (9.8) |
| Headache a | 17 (7.5) | 16 (7.0) | 12 (15.6) | 4 (9.8) |
| Nausea | 11 (4.8) | 12 (5.3) | 3 (3.9) | 1 (2.4) |
| Abdominal pain b | 8 (3.5) | 11 (4.8) | 3 (3.9) | 2 (4.9) |
| Chromaturia c | 0 | 0 | 10 (13.0) | 1 (2.4) |
| Rash d | 6 (2.6) | 2 (0.9) | 4 (5.2) | 0 |
| Dyspepsia e | 5 (2.2) | 3 (1.3) | 1 (1.3) | 0 |
| Vomiting | 5 (2.2) | 5 (2.2) | 1 (1.3) | 2 (4.9) |
| Oropharyngeal pain | 2 (0.9) | 2 (0.9) | 3 (3.9) | 0 |
| Vulvovaginal candidiasis f | 5 (2.2) | 5 (2.2) | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2) ] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions (5.3) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.4) ] Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.6) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.8) ] Rash in Patients with Mononucleosis [see Warnings and Precautions (5.9) ] Uveitis [see Warnings and Precautions (5.10) ] Most common adverse reactions (≥1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact RedHill Biopharma Inc. at 1-833-ADRHILL (1-833-237-4455) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience with TALICIA Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, NDA213004 (Talicia Holdings), as published by RedHill Biopharma Ltd, effective December 23, 2025 (SPL set 68c4e9dc-dbcf-4151-b6f7-5e4b9922b76f), via openFDA; the full label on DailyMed
What do FAERS reports show?
219 reports list amoxicillin and omeprazole and rifabutin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 10 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 14 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amoxicillin and omeprazole and rifabutin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions