Prescription medication · Penicillin Antibiotic
amoxicillin
Also sold as Amoxil. This medicine treats infections like lower respiratory infections, ear infections (otitis media), sinus infections, skin infections, and urinary tract infections.
Data updated 2026-05-15
- 73,430
- FDA reportsOften reported
- 12
- InteractionsSeveral interactions
- 1
- Recall record
What the data shows
amoxicillin (Amoxil) is a prescription Penicillin Antibiotic, more reported than most tracked drugs (73,430 FDA reports), with 12 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
amoxicillin (Amoxil) is a prescription Penicillin Antibiotic. This medicine treats infections like lower respiratory infections, ear infections (otitis media), sinus infections, skin infections, and urinary tract infections.
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections. It contains amoxicillin, an antibiotic, and clavulanate, which helps the amoxicillin work better.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.02/unit
Generic Available
Yes (50 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats infections like lower respiratory infections, ear infections (otitis media), sinus infections, skin infections, and urinary tract infections.
Common side effects
Diarrhea or loose stools, Nausea, Skin rashes
Key warnings
This medicine can cause serious allergic reactions, including fatal ones.
The sections below are summarized in plain English from amoxicillin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Amoxicillin kills bacteria by stopping them from building cell walls. Some bacteria produce a substance called beta-lactamase, which can destroy amoxicillin. Clavulanate blocks beta-lactamase, allowing amoxicillin to effectively kill the bacteria.
Side Effects (from patient reports)
Based on 73,430 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for amoxicillin, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
4,661 reports
- Acute Kidney Injury
Acute Kidney Injury
4,200 reports
- Diarrhoea
Diarrhoea
4,082 reports
- Drug Hypersensitivity
Drug Hypersensitivity
3,744 reports
- Nausea
Nausea
3,700 reports
- Dyspnoea
Dyspnoea
3,623 reports
- Pain
Pain
3,571 reports
- Rash
Rash
3,539 reports
- Fatigue
Fatigue
3,270 reports
- Renal Failure
Renal Failure
3,043 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for amoxicillin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where amoxicillin sits
amoxicillin has more FDA adverse-event reports than 81% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is amoxicillin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 73,430 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
73,430
Reports Mentioning Death
4,867
6.6% of reports — not proof of cause
Hospitalization Reports
26,975
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 4,661 |
| 2 | ACUTE KIDNEY INJURY | 4,200 |
| 3 | DIARRHOEA | 4,082 |
| 4 | DRUG HYPERSENSITIVITY | 3,744 |
| 5 | NAUSEA | 3,700 |
| 6 | DYSPNOEA | 3,623 |
| 7 | PAIN | 3,571 |
| 8 | RASH | 3,539 |
| 9 | FATIGUE | 3,270 |
| 10 | RENAL FAILURE | 3,043 |
| 13 | VOMITING | 2,874 |
| 14 | HEADACHE | 2,805 |
| 15 | PRURITUS | 2,802 |
| 16 | PYREXIA | 2,648 |
| 17 | MALAISE | 2,581 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can cause serious allergic reactions, including fatal ones. Stop taking it and get medical help right away if you have any signs of an allergic reaction. This medicine can also cause severe skin reactions. Tell your doctor if you develop a rash. It can also cause liver problems and severe diarrhea.
Known Drug Interactions
Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. See Drug Interactions in prescribing information for amoxicillin.
Mechanism: Using these drugs together as part of a treatment plan can increase the risk of side effects or change how other medicines work.
Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. See Drug Interactions in prescribing information for amoxicillin.
Mechanism: Rabeprazole changes the acid levels in your stomach, which can affect how the antibiotic amoxicillin is absorbed and used by your body.
albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline,...
Mechanism: Amoxicillin does not change the way your body processes or removes theophylline.
( 7.1 ) Concomitant use of Amoxicillin and Clavulanate Potassium and oral anticoagulants may increase the prolongation of prothrombin time.( 7.2 ) Co-administration with allopurinol increases the risk of rash. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
Mechanism: Taking these two medicines at the same time increases the chance that you will develop a skin rash. It is not fully known if the drugs themselves or the high uric acid levels in the body cause this reaction.
7 DRUG INTERACTIONS Co‑administration with probenecid is not recommended. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Co-administration of probenecid is not recommended.
Mechanism: Probenecid blocks the kidneys from removing amoxicillin from the blood. This causes the antibiotic to stay in your body longer and reach higher levels than normal.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take this medicine if I am allergic to penicillin?
Can this medicine affect my birth control?
What should I do if I get diarrhea while taking this medicine?
Can I take this medicine with other medications?
How long should I take this medicine?
What if I feel sick to my stomach when I take this?
Is it okay to share this medicine with someone else?
What do I do with leftover medicine?
Can this medicine cause a rash?
What are the common side effects of amoxicillin?
Does amoxicillin interact with other medications?
What drug class is amoxicillin?
What pregnancy or breastfeeding source fields are listed for amoxicillin?
Has amoxicillin been recalled?
Active Recalls
Subpotent drug; Clavulanate Potassium component
Teva Pharmaceuticals USA, Inc
Related Medications in Penicillin Antibiotic
Other drugs grouped near amoxicillin - same-class peers and common alternatives.
amikacin
Amikin
Amikacin is an antibiotic medicine.
Compare with amoxicillin →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with amoxicillin →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with amoxicillin →
azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
Compare with amoxicillin →
cefazolin
Ancef, Kefzol
Cefazolin is an antibiotic medicine.
Compare with amoxicillin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for amoxicillin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 73,430.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.63%.
- eszopiclone Δ 0.00 pts · 24,883 reports · Non-Benzodiazepine Hypnotic (Z-Drug) 6.63%death share
- dronedarone Δ 0.02 pts · 9,899 reports · Class III Antiarrhythmic 6.65%death share
- polyethylene glycol 3350 Δ 0.02 pts · 91,655 reports · Osmotic Laxative 6.65%death share
- ketoconazole Δ 0.02 pts · 16,231 reports · Azole Antifungal 6.65%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for amoxicillin
The FDA label for amoxicillin (sold under brand names such as Amoxil) classifies it as a prescription-only medication in the Penicillin Antibiotic class. This medicine treats infections like lower respiratory infections, ear infections (otitis media), sinus infections, skin infections, and urinary tract infections. Official labeling lists 6 commonly reported side effects, including Diarrhea or loose stools, Nausea, Skin rashes.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 73,430 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.02.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: April 30, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages