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 (amoxicillin extended-release tablets) 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 (amoxicillin extended-release tablets) -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
|Number (%) of patients|
|System Organ Class/Preferred Term*|| MOXATAG
| Pen VK
(N = 306 )
|Patients with at least one drug-related treatment-emergent adverse event Infections and infestations||32 (10.6)||45 (14.7)|
|Vulvovaginal mycotic infection||6 (2.0)||8 (2.6)|
|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.