Famotidine
Regulatory sources consulted
- openfda-label-41c182b7-7b97-e23a-e063-6394a90ab53f
- aemps-ft-63319
- ansm-rcp-67557907
- PubMed PMID:38610738 ↗
- PubMed PMID:35258842 ↗
- PubMed PMID:36190739 ↗
- CredibleMeds.org
- OpenFDA · A02BA03
- RxNorm rxcui 4278 ↗
Approved indications
- Treatment of active duodenal ulcer (DU).
- Treatment of active benign gastric ulcer (GU).
- Treatment of symptomatic nonerosive gastroesophageal reflux disease (GERD).
- Treatment of erosive esophagitis due to GERD, diagnosed by biopsy.
- Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome).
- Reduction of the risk of duodenal ulcer recurrence.
- Premedication to prevent hypersensitivity reactions to chemotherapeutic agents (e.g. taxanes, platinums). · off-label
Contraindications
Absolute
- Previous serious hypersensitivity (e.g., anaphylaxis) to famotidine or other H2 antagonists.
Clinical warnings
- Symptomatic improvement of a gastric ulcer does not preclude the possibility of malignancy. Appropriate diagnostic measures should be taken before starting treatment. — EMA SPC
- Major warning · Risk of CNS adverse reactions (e.g., confusion, delirium, hallucinations) and QT prolongation has been observed in patients with moderate to severe renal impairment. — FDA
Drug interactions
- HighTizanidineM03BX02
Mechanism: Famotidine is a weak CYP1A2 inhibitor, which can substantially increase concentrations of tizanidine (a CYP1A2 substrate).
Recommendation: Avoid concomitant use if possible. If necessary, monitor for hypotension, bradycardia, or excessive drowsiness.
FDA label
- ModerateKetoconazoleJ02AB02
Mechanism: Famotidine increases gastric pH, which reduces the absorption of drugs requiring an acidic environment for dissolution and absorption, such as ketoconazole.
Recommendation: Administer ketoconazole at least 2 hours before famotidine.
EMA SPC
- HighAtazanavirJ05AE08
Mechanism: Famotidine reduces the pH-dependent absorption of atazanavir, decreasing its plasma concentrations and potential efficacy.
Recommendation: Concomitant administration of famotidine with atazanavir/ritonavir in combination with tenofovir should be avoided. In other regimens, specific famotidine dose limits apply.
EMA SPC
Adverse events
Common (≥1%)
headache · dizziness · constipation · diarrhea
Rare but serious
pancytopenia · agranulocytosis · anaphylaxis · toxic epidermal necrolysis (TEN) · QT interval prolongation (in renal impairment) · hepatitis · seizures
Pregnancy and lactation
FDA category: B
Based on data from >1000 pregnancies, no malformative or fetotoxic effect has been observed. May be used during pregnancy if clinically needed. Excreted in breast milk in low amounts; may be used during breastfeeding.
Recent literature (PubMed)
Revisión exhaustiva que analiza la asociación entre el uso prolongado de inhibidores de la bomba de protones (IBP) y el riesgo de cáncer. El estudio sugiere que famotidina, un antagonista H2, podría ser una alternativa más segura para el tratamiento a largo plazo (>3 meses) en comparación con los IBP, debido a una menor asociación potencial con el riesgo de cáncer.
Revisión de la literatura sobre estrategias de premedicación para prevenir reacciones de hipersensibilidad (RHS) a la quimioterapia. Se destaca el uso de famotidina, como antagonista H2, en combinación con antihistamínicos H1 y corticosteroides, como un componente estándar y eficaz para reducir la incidencia y gravedad de las RHS.
Revisión Cochrane que evalúa intervenciones farmacológicas para prevenir el aumento de peso inducido por antipsicóticos. Se incluyeron tres estudios sobre antagonistas H2 (como famotidina), pero la evidencia fue de certeza muy baja y no mostró un efecto claro sobre el cambio de peso o IMC en comparación con placebo.