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OXYTETRACYCLINE ›
Regulatory · United States
Marketing authorisations
FDA
FDA
Application: NDA050287
Marketing authorisation holder: PFIZER
Local brand name: TERRAMYCIN
Indication: TABLET — ORAL
Status: approved
Read official source →
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.
Window: 20 April 2025 – 20 April 2026
Total reports: 266
Most-reported reactions
Nausea — 37 reports (13.91%) Drug Ineffective — 28 reports (10.53%) Fatigue — 27 reports (10.15%) Rash — 27 reports (10.15%) Confusional State — 26 reports (9.77%) Acute Kidney Injury — 25 reports (9.4%) Arthralgia — 25 reports (9.4%) Headache — 25 reports (9.4%) Diarrhoea — 23 reports (8.65%) Feeling Abnormal — 23 reports (8.65%)
Source database →
OXYTETRACYCLINE 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 OXYTETRACYCLINE approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for OXYTETRACYCLINE in United States?
Marketing authorisation holder not available in our data.