🇺🇸 BACAMPICILLIN HYDROCHLORIDE in United States

FDA authorised BACAMPICILLIN HYDROCHLORIDE on 23 March 1982 · 11 US adverse-event reports

Marketing authorisations

FDA — authorised 23 March 1982

  • Application: NDA050556
  • Marketing authorisation holder: PFIZER
  • Local brand name: SPECTROBID
  • Indication: FOR SUSPENSION — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Diarrhoea — 2 reports (18.18%)
  2. Blood Lactate Dehydrogenase Increased — 1 report (9.09%)
  3. Diffuse Alveolar Damage — 1 report (9.09%)
  4. Dyspnoea Exertional — 1 report (9.09%)
  5. Hypoglycaemia — 1 report (9.09%)
  6. Hypokalaemia — 1 report (9.09%)
  7. Interstitial Lung Disease — 1 report (9.09%)
  8. Leukoencephalopathy — 1 report (9.09%)
  9. Pulmonary Fibrosis — 1 report (9.09%)
  10. Rhabdomyolysis — 1 report (9.09%)

Source database →

BACAMPICILLIN HYDROCHLORIDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is BACAMPICILLIN HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 23 March 1982; FDA has authorised it.

Who is the marketing authorisation holder for BACAMPICILLIN HYDROCHLORIDE in United States?

PFIZER holds the US marketing authorisation.