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Osphos®
Clodronate
Overview
Source: Animal Drugs @ FDAAdverse event reports
Source: openFDA VeDDRAAttributed by active ingredient “CLODRONATE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.
Reported reactions
Source: openFDA VeDDRAClinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.
| Reaction (VeDDRA term) | Reports | Relative frequency |
|---|---|---|
| Polyuria | 1 | |
| Polydipsia | 1 | |
| Anorexia | 1 | |
| Depression | 1 | |
| Elevated creatinine | 1 | |
| Elevated blood urea nitrogen (BUN) | 1 | |
| Dehydration | 1 | |
| Hyponatremia | 1 | |
| Hypercalcaemia | 1 | |
| Hyperglycaemia | 1 | |
| Elevated creatine-kinase (CK) | 1 | |
| Decreased urine concentration | 1 | |
| Glucosuria | 1 | |
| Active urine sediment | 1 | |
| Acute renal failure | 1 |
Species affected
Source: openFDA VeDDRARegulatory context
New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.
Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.
Sources for this page
| Animal Drugs @ FDA | FDA CVM | Applications, sponsor, status, withdrawal |
| Animal & Veterinary Events | FDA CVM | VeDDRA adverse event aggregates by active ingredient |