· Brand: Amoxicillin Pediatric, Amoxil
Amoxicillin Side Effects: Common, Serious & FDA Warnings
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FDA-Approved For
Quick answer
Based on 101,000+ 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.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
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 | 6,008 | 5.9% |
| Drug Hypersensitivity | 5,482 | 5.4% |
| Nausea | 5,157 | 5.1% |
| Acute Kidney Injury | 4,989 | 4.9% |
| Chronic Kidney Disease | 4,938 | 4.9% |
| Dyspnoea | 5,003 | 4.9% |
| Rash | 4,648 | 4.6% |
| Fatigue | 4,549 | 4.5% |
| Pain | 4,505 | 4.4% |
| Pyrexia | 4,040 | 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 |
|---|---|
| Serious reports (any flag) | 80,597 |
| Hospitalization | 40,325 |
From the FDA-approved label, Section 5.1: Serious Allergic Reactions, including Anaphylaxis
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL. 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 for oral suspension, 600 mg/42.9 mg per 5 mL, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and institute appropriate therapy.
From the FDA-approved label, Section 5.4: Hepatic Dysfunction
Use amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL with caution in patients with evidence of hepatic dysfunction. Hepatic toxicity associated with the use of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is usually reversible. Deaths have been reported (fewer than one death reported per estimated four million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications [see Contraindications (4.2) and Adverse Reactions (6.2) ].
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.
No active or recent shortages of amoxicillin are listed. We refresh this view daily.
Is Amoxicillin Safe?
Amoxicillin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers serious allergic reactions, including anaphylaxis (Section 5.1), severe cutaneous adverse reactions (Section 5.2), drug-induced enterocolitis syndrome (dies) (Section 5.3), hepatic dysfunction (Section 5.4), clostridioides difficile -associated diarrhea (cdad) (Section 5.5), skin rash in patients with (Section 5.6), potential for microbial (Section 5.7), phenylketonurics (Section 5.8), development of drug-resistant bacteria (Section 5.9).
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 for oral suspension, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4) ] .Show full Indications and Usage
Limitations of Use Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S . pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the beta-lactamase-producing organisms listed above. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL 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. Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is a combination of amoxicillin, a penicillin-class antibacterial and clavulanate potassium, a beta-lactamase inhibitor, indicated for the treatment of pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors (1): Antibacterial exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) daycare attendance. Limitations of Use Amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MIC greater than or equal to 4 mcg/mL. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Therapy may be instituted prior to obtaining the results from bacteriological studies when there is reason to believe the infection may involve both S. pneumoniae (penicillin MIC less than or equal to 2 mcg/mL) and the beta-lactamase-producing organisms listed above. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, 600 mg/42.9 mg per 5 mL should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Frequently Asked Questions
What are the most-reported side effects of amoxicillin?
Diarrhoea, drug hypersensitivity, and nausea are among the most-reported reactions in FDA FAERS data for amoxicillin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is amoxicillin the same as Amoxicillin Pediatric?
Amoxicillin is the generic name; Amoxicillin Pediatric is a brand name for the same active ingredient. Other brand names include Amoxil. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has amoxicillin been recalled?
Yes. Amoxicillin has closed recalls on record in the FDA enforcement database; no recalls are currently active. Reasons are dominated by mislabeling, packaging defects, and CGMP deviations. See the recalls table on this page for dates, firm names, and lot quantities.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
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.