Amoxicillin Side Effects: Common, Serious & FDA Warnings
Based on 99,000+ FDA adverse event reports, the most-reported amoxicillin reactions include diarrhoea, drug hypersensitivity, and nausea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.
Common Side Effects of Amoxicillin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for amoxicillin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Diarrhoea | 5,921 | 5.9% |
| Drug Hypersensitivity | 5,453 | 5.5% |
| Nausea | 5,090 | 5.1% |
| Acute Kidney Injury | 4,946 | 4.9% |
| Chronic Kidney Disease | 4,933 | 4.9% |
| Dyspnoea | 4,923 | 4.9% |
| Rash | 4,572 | 4.6% |
| Fatigue | 4,470 | 4.5% |
| Pain | 4,465 | 4.5% |
| Pyrexia | 3,990 | 4.0% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Hypersensitivity Reactions
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including Amoxicillin and Clavulanate Potassium. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Amoxicillin and Clavulanate Potassium, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Amoxicillin and Clavulanate Potassium should be discontinued, and appropriate therapy instituted.
From the FDA-approved label, Section 5.4: Clostridioides difficile Associated Diarrhea (CDAD)
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amoxicillin and Clavulanate Potassium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD.Show full Section 5.4
Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Amoxicillin Recalls
FDA enforcement actions matched to amoxicillin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
No recalls are on record for this drug in the FDA enforcement database.
Show 8 closed recalls (2013 to 2024)
Includes resolved and terminated recalls matched to amoxicillin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2024-01-03 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE | Class II | 2 units | Terminated |
| 2024-01-03 | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. CARDINAL HEALTHCARE | Class II | 3 units | Terminated |
| 2022-06-15 | cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office | Class II | 12 bottles | Terminated |
| 2016-11-30 | Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. West-Ward Pharmaceuticals Corp. | Class III | 32,102 bottles | Terminated |
| 2016-08-31 | Superpotent drug: Out of specification test result for assay during stability testing. Teva North America | Class II | 53,328 bottles | Terminated |
| 2013-07-24 | Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050. Teva Pharmaceuticals USA, Inc. | Class III | 109,080 Bottles | Terminated |
| 2013-06-19 | Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. Teva Pharmaceuticals USA, Inc. | Class III | 758,554 bottles | Terminated |
| 2013-05-01 | Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh. Sandoz Incorporated | Class II | 8286 x 30 ct, 37108 x 500 ct. bottles | Terminated |
Amoxicillin Shortages
FDA-listed shortages of amoxicillin products. Strength and dosage-form level detail.
Is Amoxicillin Safe?
Amoxicillin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers hypersensitivity reactions (Section 5.1), severe cutaneous adverse reactions amoxicillin and clavulanate (Section 5.2), hepatic dysfunction (Section 5.3), clostridioides difficile associated diarrhea (cdad) (Section 5.4), skin rash in patients with (Section 5.5), potential for microbial (Section 5.6), phenylketonurics amoxicillin and clavulanate potassium chewable tablets and amoxicillin and clavulanate potassium for oral (Section 5.7), development of drug-resistant bacteria prescribing amoxicillin and clavulanate (Section 5.8).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Amoxicillin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Amoxicillin and Clavulanate Potassium is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections - caused by beta‑lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis .Show full Indications and Usage
Sinusitis - caused by beta‑lactamase–producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections - caused by beta‑lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. Urinary Tract Infections - caused by beta‑lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. Amoxicillin and Clavulanate Potassium is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta‑lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) Lower respiratory tract infections Acute bacterial otitis media Sinusitis Skin and skin structure infections Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 ) Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium and other antibacterial drugs, Amoxicillin and Clavulanate Potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Frequently Asked Questions
What are the most-reported side effects of amoxicillin?
Is amoxicillin the same as Amoxicillin Pediatric?
Has amoxicillin been recalled?
What do FDA recall classes mean?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.