No black box warning on record for Macrobid

As of the latest FDA labeling reviewed, Macrobid (nitrofurantoin monohydrate/macrocrystals) does not carry a black box warning. Standard warnings and precautions still apply — see the full Macrobid medicine page for the complete safety profile.

Other warnings & precautions

Contraindicated in patients with significant renal impairment (CrCl <45 mL/min or serum creatinine >2 mg/dL) — inadequate urinary drug levels reduce efficacy and elevated serum levels increase risk of systemic toxicity including peripheral neuropathy and pulmonary toxicity
Pulmonary toxicity — acute, subacute, and chronic pulmonary reactions have been observed; acute reactions (hypersensitivity pneumonitis) typically resolve after discontinuation but chronic reactions (pulmonary fibrosis) may be irreversible; perform pulmonary function tests if symptoms develop during long-term therapy
Hepatic toxicity — hepatitis, cholestatic jaundice, hepatic necrosis, and death have been reported; monitor liver function tests during prolonged therapy; discontinue immediately if signs of hepatotoxicity occur
Peripheral neuropathy — severe, irreversible sensorimotor polyneuropathy has been reported; risk increased in patients with renal impairment, anemia, diabetes mellitus, electrolyte imbalance, and vitamin B deficiency; discontinue at first sign of peripheral neuropathy
Hemolytic anemia — contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; hemolytic anemia of neonatal origin may occur in pregnant patients near term
Avoid use during labor, delivery, and at 38–42 weeks of pregnancy — risk of hemolytic anemia in the neonate due to immature erythrocyte enzyme systems; use with caution during first trimester
Not appropriate for upper urinary tract infections — not indicated for treatment of pyelonephritis or perinephric abscess due to insufficient tissue drug levels; use appropriate systemic antibiotics for upper UTI
Clostridioides difficile-associated diarrhea — can range from mild diarrhea to fatal colitis; consider in any patient developing diarrhea during or after therapy; discontinue if suspected
Neonates under 1 month of age — contraindicated due to risk of hemolytic anemia from immature erythrocyte enzyme systems
Resistance — use nitrofurantoin only when culture and sensitivity data indicate susceptibility; do not use empirically when local resistance rates exceed 20%

Other warnings & precautions

Contraindicated in patients with significant renal impairment (CrCl <45 mL/min or serum creatinine >2 mg/dL) — inadequate urinary drug levels reduce efficacy and elevated serum levels increase risk of systemic toxicity including peripheral neuropathy and pulmonary toxicity

Pulmonary toxicity — acute, subacute, and chronic pulmonary reactions have been observed; acute reactions (hypersensitivity pneumonitis) typically resolve after discontinuation but chronic reactions (pulmonary fibrosis) may be irreversible; perform pulmonary function tests if symptoms develop during long-term therapy

Hepatic toxicity — hepatitis, cholestatic jaundice, hepatic necrosis, and death have been reported; monitor liver function tests during prolonged therapy; discontinue immediately if signs of hepatotoxicity occur

Peripheral neuropathy — severe, irreversible sensorimotor polyneuropathy has been reported; risk increased in patients with renal impairment, anemia, diabetes mellitus, electrolyte imbalance, and vitamin B deficiency; discontinue at first sign of peripheral neuropathy

Hemolytic anemia — contraindicated in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency; hemolytic anemia of neonatal origin may occur in pregnant patients near term

Avoid use during labor, delivery, and at 38–42 weeks of pregnancy — risk of hemolytic anemia in the neonate due to immature erythrocyte enzyme systems; use with caution during first trimester

Not appropriate for upper urinary tract infections — not indicated for treatment of pyelonephritis or perinephric abscess due to insufficient tissue drug levels; use appropriate systemic antibiotics for upper UTI

Clostridioides difficile-associated diarrhea — can range from mild diarrhea to fatal colitis; consider in any patient developing diarrhea during or after therapy; discontinue if suspected

Neonates under 1 month of age — contraindicated due to risk of hemolytic anemia from immature erythrocyte enzyme systems

Resistance — use nitrofurantoin only when culture and sensitivity data indicate susceptibility; do not use empirically when local resistance rates exceed 20%

Macrobid Black Box Warning

No black box warning on record for Macrobid

Other warnings & precautions

Macrobid Black Box Warning

No black box warning on record for Macrobid

Other warnings & precautions