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What is Moxatag (amoxicillin)?
Moxatag (amoxicillin) is a penicillin antibiotic used to treat bacterial infections of the middle ear, tonsils, throat, larynx (laryngitis), bronchi (bronchitis), lungs (pneumonia), urinary tract, and skin. Moxatag is also used to treat gonorrhea.
Amoxicillin is rarely associated with important drug interactions.
Penicillins such as amoxicillin are generally considered safe for use by pregnant women who are not allergic to penicillin. Small amounts of amoxicillin may be excreted in breast milk and may cause diarrhea or allergic responses in nursing infants. Amoxicillin is generally considered safe to use while breastfeeding.
What are the important side effects of Moxatag (amoxicillin)?
Side effects due to amoxicillin include
- abdominal pain,
- easy bruising,
- rash, and
- allergic reactions.
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.
Serious but rare reactions include:
- severe allergic reactions (anaphylaxis), and
- low platelet (thrombocytopenia) or red blood cell count.
Amoxicillin 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 amoxicillin (diarrhea, fever, abdominal pain, and possibly shock) should contact their physician immediately.
Moxatag (amoxicillin) side effects list for healthcare professionals
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.
Clinical Study Experience
Tonsillitis and/or Pharyngitis
In a controlled Phase 3 trial, 302 adult and pediatric patients ( ≥ 12 years) were treated with Moxatag 775 mg once-daily for 10 days and 306 adult and pediatric patients ( ≥ 12 years) were treated with penicillin VK 250 mg QID for 10 days.
In this clinical trial, the majority of treatment-emergent adverse reactions were of a mild and transient nature with similar frequency reported in both treatment groups. Discontinuation due to drug-related treatment-emergent adverse reactions occurred in 1.3% of the Moxatag-treated patients and 3.3% of the penicillin VK-treated patients.
The most frequently reported adverse reactions ( ≥ 1%) which were suspected or probably drug-related are shown in Table 1.
Table 1: Drug-Related Treatment-Emergent Adverse
Reactions by System Organ Class Experienced by ≥ 1% of Patients in Either
Treatment Group – ITT/Safety Population
|System Organ Class/
|Number (%) of patients|
(N = 306 )
|Patients with at least one drug-related treatment-emergent adverse event||32 (10.6)||45 (14.7)|
|Infections and infestations|
|Vulvovaginal mycotic infection||6 (2.0)||8 (2.6)|
|Diarrhea||5 (1.7)||6 (2.0)|
|Vomiting||2 (0.7)||5 (1.6)|
|Abdominal pain||1 (0.3)||3 (1.0)|
|Nervous system disorders|
|Headache||3 (1.0)||3 (1.0)|
|*Presented in decreasing order of frequency in the Moxatag column within each system organ class.|
Adverse Reactions For Other Amoxicillin Products
The following adverse reactions have been reported for other products containing amoxicillin:
Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Nausea, vomiting, diarrhea, and hemorrhagic/pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions: Anaphylaxis.
Serum sickness like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson Syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported. (NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.)
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Renal: Crystalluria has also been reported.
Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
What drugs interact with Moxatag (amoxicillin)?
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of Moxatag and probenecid may result in increased and prolonged blood levels of amoxicillin. The clinical relevance of this finding has not been evaluated.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
As with other antibiotics, amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and potentially resulting in reduced efficacy of combined oral estrogen/progesterone contraceptives.
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Related Disease Conditions
Sinus Infection (Sinusitis)
Sinus infection (sinusitis) is caused by allergies, infection, and chemicals or other irritants of sinuses. Signs and symptoms are headache, fever, and facial tenderness, pressure, or pain. Treatments of sinus infections are generally with antibiotics and at times, home remedies.
Inner Ear Infection (Symptoms, Signs, Treatments, Home Remedies)
An inner ear infection or otitis interna is caused by viruses or bacteria and can occur in both adults and children. An inner ear infection can cause symptoms and signs, for example, a severe ear, dizziness, vertigo, nausea and vomiting, and vertigo. An inner ear infection also may cause inflammation of the inner ear or labyrinthitis. Inner ear infections are not contagious; however, the bacteria and viruses that cause the infection can be transmitted to other people. Good hygiene practices will help decrease the chances of the infection spreading to others. Inner ear infection symptoms and signs like ear pain and nausea may be relieved with home remedies or over the counter (OTC) medication. Some inner ear infections will need to be treated and cured with antibiotics or prescription pain or antinausea medication.
Ear Infection Home Treatment
Infections of the outer, middle, and inner ear usually are caused by viruses. Most outer (swimmer's ear) and middle ear (otitis media) infections can be treated at home with remedies like warm compresses for ear pain relief, tea tree, ginger, or garlic oil drops. Symptoms of an outer ear (swimmer's ear) and middle ear infection include mild to severe ear pain, pus draining from the ear, swelling and redness in the ear, and hearing problems. Middle and inner ear infections may cause fever, and balance problems. Inner ear infections also may cause nausea, vomiting, vertigo, ringing in the ear, and labyrinthitis (inflammation of the inner ear). Most outer and middle ear infections do not need antibiotics. Inner ear infections should be treated by a doctor specializing in ear and hearing problems.
Inner Ear Infection (Labyrinthitis)
Labyrinthitis is inflammation of the labyrinth (the part of the ear responsible for balance and hearing). Doctors do not know the exact cause of labyrinthitis; however, they often are associated viral infections of the inner ear. Symptoms of labyrinthitis are ear pain or earache, ear discharge, problems with balance and walking, ringing in the ears, dizziness, nausea, vomiting, and vertigo. Viral infections associated with labyrinthitis are contagious. Home remedies may help labyrinthitis symptoms and signs. Over-the-counter (OTC) and prescription medication may treat inner ear infections, labyrinthitis symptoms like vertigo and nausea, and help ear pain.
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.
Gonorrhea In Women
Gonorrhea is a bacterial infection transmitted during sexual contact. In women, symptoms include a yellow vaginal discharge, burning or frequent urination, and redness, swelling, burning and itching of the vaginal area. Gonorrhea can be treated with injectable (penicillin) or oral medications.
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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 and drug interactions sections courtesy of the U.S. Food and Drug Administration