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Pregabalin
Overview
Source: Animal Drugs @ FDAAdverse event reports
Source: openFDA VeDDRAAttributed by active ingredient “PREGABALIN”. 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 |
|---|---|---|
| Lack of efficacy - NOS | 30 | |
| Lethargy (see also Central nervous system depression in Neurological) | 16 | |
| Ataxia | 15 | |
| Overdose | 12 | |
| Wobbliness | 10 | |
| Partial lack of efficacy | 9 | |
| Intentional misuse | 9 | |
| Sedation | 7 | |
| Vomiting | 6 | |
| Seizure NOS | 5 | |
| Medication error NOS | 5 | |
| Solution, Abnormal | 4 | |
| Drooling | 4 | |
| Sedation prolonged | 4 | |
| Walking difficulty | 4 | |
| Hard, clumping | 4 | |
| Weakness | 4 | |
| Behavioural disorder NOS | 4 | |
| Sleepiness - systemic disorder | 3 | |
| Vocalisation | 3 |
Species affected
Source: openFDA VeDDRARegulatory context
Conditional approval (CNADA). Authorised under the Minor Use and Minor Species Animal Health Act of 2004. Conditional approval requires complete demonstration of safety and manufacturing consistency but permits commercial distribution on a reasonable expectation of effectiveness while confirmatory clinical trials are completed. CNADAs are granted for one-year terms, renewable up to five years.
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 |