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OXYTETRACYCLINE CALCIUM ›
Regulatory · United States
Marketing authorisations
FDA
FDA
Application: ANDA060595
Marketing authorisation holder: PFIZER
Local brand name: TERRAMYCIN
Indication: SYRUP — 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: 14
Most-reported reactions
Dizziness — 3 reports (21.43%) Cystitis — 2 reports (14.29%) Dyspnoea — 2 reports (14.29%) Abdominal Pain Upper — 1 report (7.14%) Abscess Sterile — 1 report (7.14%) Acute Kidney Injury — 1 report (7.14%) Alopecia — 1 report (7.14%) Anaemia — 1 report (7.14%) Anxiety — 1 report (7.14%) Arrhythmia — 1 report (7.14%)
Source database →
OXYTETRACYCLINE CALCIUM 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 CALCIUM approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for OXYTETRACYCLINE CALCIUM in United States?
Marketing authorisation holder not available in our data.