Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium)

What Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Amoxicillin and clavulanate potassium extended-release tablets is indicated for the treatment of infections in adults and pediatric patients weighing greater than or equal to 40 kg who are able to swallow tablets with: community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase-producing pathogens (i.e., H. influenzae, M. catarrhalis, H. parainfluenzae, K. …

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →

Label quoted: the one for the most common form (tablet, multilayer, extended release, oral), Amoxicillin and Clavulanate Potassium, Sportpharm LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.

The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

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Boxed warning

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The label quoted above has no boxed warning.

0 of 3 FDA labels for this medicine have a boxed warning.

Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) side effects

Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.

The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylactic reactions [se e 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)] Hepatic Dysfunction [see Warnings and Precautions (5.4)] Clostridioides difficile -associated diarrhea (CDAD) [se e Warnings and Precautions (5.5)] Skin Rash in Patients with Mononucleosis [see Warnings and Precautions (5.6)] The most frequently reported adverse reactions were (incidence > 2%), diarrhea, vaginal mycosis, nausea, and loose stools.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. In clinical trials, 5,643 patients have been treated with amoxicillin and clavulanate potassium extended-release tablets. The most frequently reported adverse reactions which were suspected or probably drug- related were diarrhea (15%), vaginal mycosis (3%), nausea (2%), and loose stools (2%). Amoxicillin and clavulanate potassium extended-release tablets had a higher rate of diarrhea which required corrective therapy (4% versus 3% for amoxicillin and clavulanate potassium extended-release tablets and all comparators, respectively). Two percent of patients discontinued therapy because of drug-related adverse reactions. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-marketing use of amoxicillin and clavulanate potassium products, including amoxicillin and clavulanate potassium extended-release tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3, 5.5)]. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)]. Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis [see Warnings and Precautions (5.1, 5.2, 5.6)]. Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibacterials, but the significance of these findings is unknown.

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. This is part of the section. Read the full label on DailyMed →

Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) drug interactions

Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.

Co-administration with probenecid is not recommended. (7.1) Concomitant use of amoxicillin and clavulanate potassium extended-release tablets and oral anticoagulants may increase the prolongation of prothrombin time. (7.2) Co-administration with allopurinol increases the risk of rash. (7.3) Amoxicillin and clavulanate potassium extended-release tablets may reduce efficacy of oral contraceptives.

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(7.4) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use with amoxicillin and clavulanate potassium extended-release tablets may result in increased and prolonged blood levels of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin substantially 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. In controlled clinical trials of amoxicillin and clavulanate potassium extended-release tablets, 25 patients received concomitant allopurinol and amoxicillin and clavulanate potassium extended-release tablets. No rashes were reported in these patients. However, this sample size is too small to allow for any conclusions to be drawn regarding the risk of rashes with concomitant amoxicillin and clavulanate potassium extended-release tablets and allopurinol use. 7.4 Oral Contraceptives Amoxicillin and clavulanate potassium extended-release tablets may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium extended release tablets, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →

Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) dosage

Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.

Adults and Pediatric Patients weighing greater than or equal to 40 kg who are able to swallow tablets: The recommended dosage of amoxicillin and clavulanate potassium extended-release tablets is 4,000 mg/250 mg daily in divided doses at the start of a meal according to the following table (2): Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg) tablets every 12 hours 7 to 10 days 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium extended-release tablets should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance.

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Amoxicillin and clavulanate potassium extended-release tablets is not recommended to be taken with a high-fat meal because clavulanate absorption is decreased [see Clinical Pharmacology (12.3)]. 2.2 Dosage in Adult Patients The recommended dosage of amoxicillin and clavulanate potassium extended-release tablets is 4,000 mg/250 mg daily in divided doses according to the following table: Table 1: Recommended Dosage of Amoxicillin and Clavulanate Potassium Extended-Release Tablets in Adult Patients Indication Dose Duration Acute bacterial sinusitis Two (1,000 mg/62.5 mg) tablets every 12 hours 10 days Community-acquired pneumonia Two (1,000 mg/62.5 mg) tablets every 12 hours 7 to 10 days Amoxicillin and clavulanate potassium extended-release tablets can be split in half along the score line for patients with difficulty swallowing the tablets whole. Both halves of the tablet must be taken immediately. 2.3 Dosage in Pediatric Patients Pediatric patients who weigh 40 kg or more and can swallow tablets should receive the adult dose [see Dosage and Administration (2.2) and Use in Specific Populations (8.4)]. 2.4 Dosage in Patients with Hepatic Impairment Hepatically impaired patients should be dosed with caution and hepatic function monitored at regular intervals [see Warnings and Precautions (5.4)]. 2.5 Switching between Dosage Forms and between Strengths Amoxicillin and clavulanate potassium extended-release tablet is NOT substitutable on a mg-to-mg basis with other formulations of amoxicillin and clavulanate potassium. In addition, the extended-release tablets provide an extended time course of plasma amoxicillin concentrations compared to immediate-release tablets. Thus, two amoxicillin and clavulanate potassium 500 mg tablets are not equivalent to one amoxicillin and clavulanate potassium extended-release 1,000 mg tablet.

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. This is part of the section. Read the full label on DailyMed →

Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) in pregnancy

Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.

Risk Summary Available data from published epidemiologic studies and pharmacovigilance case reports over several decades of use with amoxicillin and clavulanate during pregnancy have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes.

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A study in women with preterm prelabor rupture of membranes (PPROM) reported that prophylactic treatment with amoxicillin and clavulanate may be associated with an increased risk of necrotizing enterocolitis in neonates (see Data). Reproduction studies performed in pregnant rodents, given oral doses up to approximately 1.6 times the amount of amoxicillin and 13 times the amount of clavulanate in the Maximum Human Recommended Dose (MHRD) of amoxicillin and clavulanate potassium extended-release tablets, revealed no evidence of harm to the fetus (see Data). The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Human Data One randomized, controlled trial included 4,826 pregnant women with premature rupture of fetal membranes who were randomly assigned to 250 mg erythromycin (n=1,197), 250 mg amoxicillin and 125 mg clavulanic acid (amoxicillin and clavulanate, n=1,212), amoxicillin and clavulanate and erythromycin (n=1,192), or placebo (n=1,225) four times daily for 10 days or until delivery. Amoxicillin and clavulanate was associated with a significantly increased rate of proven neonatal necrotizing enterocolitis: 1.9% (n = 24) in the amoxicillin and clavulanate only group versus 0.5% (n = 6) in the placebo group (p = 0.001), and 1.8% (n = 44) in the any amoxicillin and clavulanate group versus 0.7% (n =17) in the no amoxicillin and clavulanate group (p = 0.0005). Animal Data Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate (2:1 ratio formulation) at oral doses up to 1,200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate. In terms of body surface area, the doses in rats were 1.6 times the Maximum Human Recommended Dose (MHRD) of amoxicillin and 13 times the MHRD for clavulanate in amoxicillin and clavulanate potassium extended-release tablets. For mice, these doses were 0.9 and 7.4 times the MHRD of amoxicillin and clavulanate, respectively.

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →

When Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) should not be used

Quoted from the “Contraindications” section of the FDA-approved label.

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium extended-release tablets or to other β‑lactams (e.g., penicillins or cephalosporins). (4.1) History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium extended-release tablets. (4.2) In patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients.

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(4.3) 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium extended-release tablets is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium extended-release tablets is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with treatment with amoxicillin/clavulanate potassium. 4.3 Renal Impairment Amoxicillin and clavulanate potassium extended-release tablets is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min) and in hemodialysis patients.

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →

Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium) overdose

Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients. In the case of overdosage, discontinue amoxicillin and clavulanate potassium extended-release tablets, treat symptomatically, and institute supportive measures as required.

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If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. A prospective study of 51 pediatric patients at a poison control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms and do not require gastric emptying 1. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In the case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis.

— FDA label: Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026. Read the full label on DailyMed →

Forms and how it is given

Same medicine, other forms and combinations

Prescription medicine pages on this site that share an active ingredient with this one, from the FDA NDC Directory. A combination is a different medicine: ask your pharmacist before you switch.

The same medicine as another salt or form

• Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)amoxicillin / clavulanate · 196 products
• Amoxicillin and clavulanate potassium (amoxicillin / clavulanic acid)amoxicillin / clavulanic acid · 6 products

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Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

• Sportpharm LLC1 product
• Sandoz Inc1 product
• USAntibiotics, LLC1 product

FDA approval history

• NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
• ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (1)

• ANDA090227Sandoz · April 21, 2010

Shortage status

The FDA drug shortage list does not show these products.

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Recalls

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Official identifiers

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• Sandoz IncMaker or distributor
• USAntibiotics, LLCMaker or distributor
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Sources

1. FDA-approved label on DailyMed (National Library of Medicine) — Amoxicillin and Clavulanate Potassium, Sportpharm LLC, effective April 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

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