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Moxatag

Last reviewed on RxList: 6/27/2017
Moxatag Side Effects Center

Last reviewed on RxList 6/27/2017

Moxatag (amoxicillin extended-release) is a penicillin antibiotic used to treat different types of infections caused by bacteria, such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or salmonella infection. Moxatag is sometimes used with another antibiotic called clarithromycin (Biaxin) to treat stomach ulcers caused by Helicobacter pylori infection. This combination may be used with a stomach acid reducer called lansoprazole (Prevacid). Common side effects of Moxatag include nausea, vomiting, stomach pain, diarrhea, vaginal itching or discharge, headache, or swollen, black or "hairy" tongue.

The recommended dose of Moxatag is 775 mg once daily taken within 1 hour of finishing a meal for 10 days. Moxatag may interact with probenecid, blood thinners, other antibiotics, or sulfa drugs. Tell your doctor all medications and supplements you use. During pregnancy, Moxatag should be used only if prescribed. Moxatag passes into breast milk. Consult your doctor before breastfeeding.

Our Moxatag (amoxicillin extended-release) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Moxatag Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • white patches or sores inside your mouth or on your lips;
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • pale or yellowed skin, yellowing of the eyes, dark colored urine, fever, confusion or weakness;
  • severe tingling, numbness, pain, muscle weakness;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • stomach pain, nausea, vomiting;
  • vaginal itching or discharge;
  • headache; or
  • swollen, black, or "hairy" tongue.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Moxatag (Amoxicillin Extended-Release Tablets)

Moxatag Professional Information

SIDE EFFECTS

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/
Preferred Term*
Number (%) of patients
MOXATAG
(N =302)
Penicillin VK
(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)
Gastrointestinal disorders
  Diarrhea 5 (1.7) 6 (2.0)
  Nausea 4(1.3) 2 (0.7)
  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 (See WARNINGS AND PRECAUTIONS).

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.

Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported rarely.

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.

Read the entire FDA prescribing information for Moxatag (Amoxicillin Extended-Release Tablets)

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© Moxatag Patient Information is supplied by Cerner Multum, Inc. and Moxatag Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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