Zithromax Side Effects

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Zithromax Side Effects

In clinical trials, most of the reported Zithromax side effects were mild to moderate in severity and were reversible upon discontinuation of the drug. Approximately 0.7% of the patients (adults and children) from the multiple-dose clinical trials discontinued azithromycin therapy because of treatment-related side effects. Most of the Zithromax side effects leading to discontinuation were related to the gastrointestinal tract, e.g., nausea, vomiting, diarrhea, or abdominal pain. Potentially serious side effects of angioedema and cholestatic jaundice were reported rarely.

Multiple-Dose Regimen: Overall, the most common Zithromax side effects in adult patients receiving a multiple-dose regimen of azithromycin were related to the gastrointestinal system with diarrhea/loose stools (5%), nausea (3%), and abdominal pain (3%) being the most frequently reported.

No other Zithromax side effects occurred in patients on the multiple-dose regimen of azithromycin with a frequency greater than 1%. Side effects that occurred with a frequency of 1% or less included the following:

Cardiovascular:

• palpitations
• chest pain.

Gastrointestinal:

• dyspepsia
• flatulence
• vomiting
• melena
• cholestatic jaundice

Genitourinary:

• monilia
• vaginitis
• nephritis

Nervous System:

• dizziness
• headache
• vertigo
• somnolence

General:

• fatigue

Allergic:

• rash
• photosensitivity
• angioedema

Single 1-gram Dose Regimen: Overall, the most common side effects in patients receiving a single-dose regimen of 1 gram of azithromycin were related to the gastrointestinal system and were more frequently reported than in patients receiving the multiple-dose regimen.

Side effects that occurred in patients on the single one-gram dosing regimen of azithromycin with a frequency of 1% or greater included diarrhea/loose stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%), and vaginitis (1%).

Single 2-gram Dose Regimen: Overall, the most common side effects in patients receiving a single 2-gram dose of azithromycin were related to the gastrointestinal system. Side effects that occurred in patients in this study with a frequency of 1% or greater included nausea (18%), diarrhea/loose stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), dyspepsia (1%), and dizziness (1%). The majority of these complaints were mild in nature.

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