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What is Augmentin (amoxicillin and clavulanic acid)?
Augmentin (amoxicillin and clavulanic acid) contains a penicillin antibiotic and a beta-lactamase inhibitor used to treat infections of the middle ear (otitis media), tonsillitis, throat infections (pharyngitis), laryngitis, bronchitis, sinusitis, and pneumonia. It is also used in treating urinary tract infections, and skin infections.
Common side effects of Augmentin include abdominal discomfort, bloating, diarrhea, gas, headache, heartburn, nausea, vomiting, bloody or prolonged diarrhea, easy bruising or bleeding, reversible hepatitis, rash, and allergic reactions.
Use of Augmentin in pregnant women has not been well studied. Penicillins are generally considered safe for use by pregnant women who are not allergic to penicillin. Augmentin is excreted in breast milk and may cause diarrhea in the infant.
What are the important side effects of Augmentin (amoxicillin and clavulanic acid)?
Common side effects are:
Other important side effects include:
- bloody or prolonged diarrhea,
- easy bruising or bleeding,
- reversible hepatitis,
- rash, and
- allergic reactions.
Serious but rare reactions include seizures, severe allergic reactions (anaphylaxis), and low platelet or red blood cell count.
Antibiotics can alter the normal bacteria in the colon and encourage overgrowth of some bacteria such as Clostridium difficile which causes inflammation of the colon (pseudomembranous colitis). Patients who develop signs of pseudomembranous colitis after starting Augmentin (diarrhea, fever, abdominal pain, and possibly shock) should contact their physician immediately.
People who are allergic to the cephalosporin class of antibiotics, which are related to the penicillins, for example, cefaclor (Ceclor), cephalexin (Keflex), and cefprozil (Cefzil), may or may not be allergic to penicillins.
Augmentin (amoxicillin and clavulanic acid) side effects list for healthcare professionals
The following are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions
- Hepatic Dysfunction
Clinical Trial 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.
The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.
In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of Augmentin for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of Augmentin for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes.
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of Augmentin. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Augmentin.
Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported.
Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with Augmentin. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported.
Interstitial nephritis, hematuria, and crystalluria have been reported.
Hemic And Lymphatic Systems
Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with Augmentin. There have been reports of increased prothrombin time in patients receiving Augmentin and anticoagulant therapy concomitantly.
Central Nervous System
Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
What drugs interact with Augmentin (amoxicillin and clavulanic acid)?
Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with Augmentin may result in increased and prolonged blood concentrations of amoxicillin. Coadministration of probenecid is not recommended.
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 with Augmentin. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
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.
Augmentin may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
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 Augmentin, 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.
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Related Disease Conditions
Tonsillitis is a contagious infection with symptoms of bad breath, snoring, congestion, headache, hoarseness, laryngitis, and coughing up blood. Tonsillitis can be caused acute infection of the tonsils, and several types of bacteria or viruses (for example, strep throat or mononucleosis). There are two types of tonsillitis, acute and chronic. Acute tonsillitis lasts from one to two weeks while chronic tonsillitis can last from months to years. Treatment of tonsillitis and adenoids include antibiotics, over-the-counter medications, and home remedies to relieve pain and inflammation, for example, salt water gargle, slippery elm throat lozenges, sipping warm beverages and eating frozen foods (ice cream, popsicles), serrapeptase, papain, and andrographism Some people with chronic tonsillitis may need surgery (tonsillectomy or adenoidectomy).
Middle Ear Infection (Otitis Media)
Middle ear infection (otitis media) is inflammation of the middle ear. There are two forms of this type of ear infection, acute and chronic. Acute otitis media is generally short in duration, and chronic otitis media generally lasts several weeks. Babies, toddlers, and children with a middle ear infection may be irritable, pull and tug at their ears, and experience numerous other symptoms and signs. Treatment depends upon the type of ear infection.
Sore throat (throat pain) usually is described as pain or discomfort in the throat area. A sore throat may be caused by bacterial infections, viral infections, toxins, irritants, trauma, or injury to the throat area. Common symptoms of a sore throat include a fever, cough, runny nose, hoarseness, earaches, sneezing, and body aches. Home remedies for a sore throat include warm soothing liquids and throat lozenges. OTC remedies for a sore throat include OTC pain relievers such as ibuprofen or acetaminophen. Antibiotics may be necessary for some cases of sore throat.
Laryngitis is an inflammation of the voice box (vocal cords). The most common cause of acute laryngitis is infection, which inflames the vocal cords. Symptoms may vary from degree of laryngitis and age of the person (laryngitis in infants and children is more commonly caused by croup). Common symptoms include a "barky" cough, a hoarse cough, fever, cold, runny nose, dry cough, and loss of voice. Chronic laryngitis generally lasts more than three weeks. Causes other than infection include smoking, excess coughing, GERD, and more. Treatment depends on the cause of laryngitis.
Is Pneumonia Contagious?
Pneumonia is inflammation of the lung usually caused by bacterial or viral infection (rarely, also by fungi) that causes the air sacs to fill with pus. If inflammation affects both lungs, the infection is termed double pneumonia. If it affects one lung, it is termed single pneumonia. If it affects only a certain lobe of a lung it's termed lobar pneumonia. Most pneumonias are caused by bacteria and viruses, but some pneumonias are caused by inhaling toxic chemicals that damage lung tissue.
Is Tonsillitis Contagious?
Tonsillitis is a common infection, especially in kids. Tonsillitis is caused by viruses and bacteria like the flu and herpes simplex virus, and Streptococcus bacteria. These viruses and bacterium are spread person to person. Symptoms of tonsillitis are a yellow or white coating on the tonsils, throat pain, pain when swallowing, and hoarseness.
Bronchitis is inflammation of the airways in the lung. Acute bronchitis is short in duration (10-20 days) in comparison with chronic bronchitis, which lasts for months to years. Causes of acute bronchitis include viruses and bacteria, which means it can be contagious. Acute bronchitis caused by environmental factors such as pollution or cigarette smoke is not contagious. Common symptoms for acute bronchitis include nasal congestion, cough, headache, sore throat, muscle aches, and fatigue. Acute bronchitis in children also my include runny nose, fever, and chest pain. Treatment for acute bronchitis are OTC pain relievers, cough suppressants (although not recommended in children), and rest. Infrequently antibiotics may be prescribed to treat acute bronchitis.
Is Sore Throat (Pharyngitis) Contagious?
The medical term for a sore throat is pharyngitis. There are many causes of a sore throat such as medications, diseases (GERD, cancer, AIDS), infections (Streptococcus or strep, mononucleosis), allergies, and smoking. Symptoms are a red, swollen throat; fever, and swollen lymph nodes. Treatment for sore throat depends on the cause.
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Medications & Supplements
- Augmentin (amoxicillin and clavulanic acid, Augmentin XR, Augmentin ES-600, Amoclan
- Amoxicillin vs. Augmentin (Comparison of Side Effects and Antibiotic Uses)
- amoxicillin/clavulanic acid suspension - oral, Augmentin
- amoxicillin/clavulanic acid extended-release - oral, Augmentin XR
- amoxicillin/clavulanic acid chewable tablet - oral, Augmentin
- amoxicillin/clavulanic acid 875 mg/125 mg - oral, Augmentin
- amoxicillin/clavulanic acid 500 mg/125 mg - oral, Augmentin
- Suprax (cefixime) vs. Augmentin
Prevention & Wellness
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects list and drug interactions sections courtesy of the U.S. Food and Drug Administration