In controlled Phase 3 clinical trials with Zmax, the majority of the reported treatment-related
adverse reactions were gastrointestinal in nature and mild to moderate in severity.
Overall, the most common treatment-related adverse reactions in adult subjects receiving
a single 2.0 dose of Zmax were diarrhea/loose stools (11.6%), nausea (3.9%), abdominal
pain (2.7%), headache (1.3%), and vomiting (1.1%). The incidence of treatment-related
gastrointestinal adverse reactions was 17.2% for Zmax and 9.7% for pooled comparators.
No other treatment-related adverse events occurred in subjects on Zmax with a frequency
of ≥1%.
Treatment-related adverse reactions following Zmax treatment that occurred with
a frequency of <1% included the following:
Cardiovascular: palpitations, chest pain
Gastrointestinal: constipation, dyspepsia, flatulence, gastritis, oral moniliasis,
loose stools
Genitourinary: vaginitis
Nervous System: dizziness, vertigo
General: asthenia
Allergic: rash, pruritus, urticaria
Special Senses: taste perversion
Laboratory Abnormalities
In subjects with normal baseline values, the following clinically significant laboratory
abnormalities (irrespective of drug relationship) were reported in Zmax clinical
trials:
- with an incidence of greater than or equal to 1%: reduced lymphocytes and increased
eosinophils; reduced bicarbonate;
- with an incidence of less than 1%: leukopenia, neutropenia, elevated bilirubin,
AST, ALT, BUN, creatinine, alterations in potassium.
Where follow-up was provided, changes in laboratory tests appeared to be reversible.
Post-Marketing Experience with Azithromycin Immediate Release
Adverse events reported with azithromycin during the post-marketing period for which
a causal relationship may not be established include:
Allergic: arthralgia, edema, urticaria and angioedema
Cardiovascular: palpitations and arrhythmias including ventricular tachycardia
and hypotension. There have been rare reports of QT prolongation and
torsades de
pointes.
Gastrointestinal: anorexia, constipation, dyspepsia, flatulence, vomiting/diarrhea
rarely resulting in dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis
and rare reports of tongue discoloration
General: asthenia, paresthesia, fatigue, malaise and anaphylaxis (rarely
fatal)
Genitourinary: interstitial nephritis, acute renal failure, moniliasis and
vaginitis
Hematopoietic: thrombocytopenia, mild neutropenia
Liver/Biliary: abnormal liver function including hepatitis and cholestatic
jaundice, as well as rare cases of hepatic necrosis and hepatic failure, some of
which have resulted in death
Nervous System: convulsions, dizziness/vertigo, headache, somnolence, hyperactivity,
nervousness, agitation and syncope
Psychiatric: aggressive reaction and anxiety
Skin/Appendages: pruritus, rash, photosensitivity, rarely serious skin reactions
including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Special Senses: hearing disturbances including hearing loss, deafness and/or
tinnitus and rare reports of taste perversion and/or loss