Last reviewed 2026-04-20 · How we verify

Pylera

At a glance

Approved indications

No approved indications tracked.

Boxed warnings

• WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans [see Warning and Precautions (5.1) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans ( 5.1 ).

Common side effects

• Diarrhea
• Nausea
• Abnormal feces
• Headache
• Dysgeusia
• Dyspepsia
• Vomiting
• Back pain
• Tongue darkening
• Anxiety
• Gastritis
• Gastroenteritis

Serious adverse events

• Reversible neutropenia (leucopenia)
• Reversible thrombocytopenia
• QT prolongation
• Acute generalized exanthematous pustulosis (AGEP)
• Convulsive seizures
• Encephalopathy
• Aseptic meningitis
• Optic and peripheral neuropathy
• Pancreatitis
• Duodenal ulcer

Key clinical trials

• Tailored Vs. Empirical Helicobacter Pylori Infection Treatment (PHASE4)
• Helicobacter Pylori Eradication Therapy in Portugal (NA)
• Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection (EARLY_PHASE1)
• Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication (NA)
• Helicobacter Pylori and Body Iron in Adults (PHASE4)
• Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy (PHASE3)
• Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori (PHASE3)
• An Open-Label Trial Of Reduced- Dose Pylera, Amoxicillin, and Esomeprazole in the Treatment Of Helicobacter Pylori Infection (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.