Regulatory product record
RECONCILE
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Owner information handout
Plain-language medication information to review with the owner. Open the handout to print it or download a PDF.
Product identity
- Brand name
- RECONCILE
- DIN
- 02307960
- DPD drug code
- 79362
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- ORAL
- Pharmaceutical form(s)
- TABLET (CHEWABLE)
- Ingredients
- FLUOXETINE (FLUOXETINE HYDROCHLORIDE) (16 MG)
- Species (DPD record)
- DOGS
- Company
- PEGASUS LABORATORIES INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 79362
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Pending clinical review (PROPOSED)— applies to the facts and dose entries in this species selection; individual source records retain their own status.
Indications2
Separation anxiety (FDA-approved w/ behavior modification), compulsive/OCD behaviors, aggression
DogExtra-label (EXTRA_LABEL)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Separation anxiety (FDA-approved w/ behavior modification), compulsive/OCD behaviors, aggression — Reconcile: labeled for separation anxiety; other uses extra-label
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Urine spraying/marking, aggression, anxiety, compulsive behaviors
CatExtra-label (EXTRA_LABEL)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Original excerpt: Urine spraying/marking, aggression, anxiety, compulsive behaviors — Extra-label
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Indications table · Not applicable · Extra-label (EXTRA_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens5
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
Select a species above to calculate a dose.
Adverse effects206
Anorexia (often transient), lethargy, GI effects, irritability/hyperactivity, panting — Common
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Aggression in previously non-aggressive dogs — Reported
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Seizures — Reported in field trials, causality unclear
DogNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Dog · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Anxiety/irritability, sleep disturbance, anorexia, altered elimination — Reported
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Side Effects / Adverse Effects table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Appetite suppression
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Table 1 (p.630), row: Fluoxetine, Adverse Effects column · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Manual
- Cat · Table 1 (p.630), row: Fluoxetine, Adverse Effects column · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Manual
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Lack of efficacy - NOS347 reports
- Vomiting322 reports
- Anorexia309 reports
- Depression219 reports
- Diarrhoea170 reports
- Seizure NOS131 reports
- Behavioural disorder NOS125 reports
- Accidental exposure120 reports
- Decreased appetite119 reports
- Lethargy (see also Central nervous system depression in Neurological)112 reports
- Lethargy (see also Central nervous system depression in 'Neurological')105 reports
- Aggression102 reports
Cat
- Lack of efficacy - NOS34 reports
- Vomiting32 reports
- Behavioural disorder NOS22 reports
- Anorexia21 reports
- Lethargy (see also Central nervous system depression in Neurological)21 reports
- Not eating21 reports
- Weight loss21 reports
- Ataxia18 reports
- Death by euthanasia15 reports
- Diarrhoea13 reports
- Hyperglycaemia13 reports
- Intentional misuse12 reports
Monitoring1
Behavior response, appetite/weight; onset of action may take 2+ weeks due to long half-life/accumulation
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Monitoring Parameters · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Contraindications3
Known hypersensitivity; concurrent MAO inhibitors (5-week washout after fluoxetine, 2-week before starting selegiline)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
MAOIs, seizures
DogCatNot applicable (NOT_APPLICABLE)2 source records · View provenance
- Dog · Table 1 (p.630), row: Fluoxetine, Contraindications column · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Manual
- Cat · Table 1 (p.630), row: Fluoxetine, Contraindications column · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Manual
Precautions4
Dogs with epilepsy/seizure history (label warning); do not combine with seizure-threshold-lowering drugs (acepromazine, chlorpromazine); caution in diabetes mellitus; reduce dose in severe hepatic impairment
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Contraindications & Warnings table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Always pair with a structured behavior-modification program — medication alone is not expected to resolve the underlying behavioral issue.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not stop abruptly after long-term use — taper.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Do not use in dogs with a seizure history without careful risk discussion — this is an explicit label caution, not just a general one.
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Clinical pearl · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Interactions7
MAO inhibitors (amitraz, selegiline) — Contraindicated — high serotonin syndrome risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Tramadol — ↓ conversion to active metabolite, ↑ serotonin syndrome/seizure risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
TCAs (clomipramine, amitriptyline) — ↑ TCA levels, ↑ serotonin syndrome risk
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Trazodone — ↑ trazodone plasma levels
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Diazepam, alprazolam — ↑ benzodiazepine levels
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Drug Interactions table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics4
Bioavailability — ~70% (dog); ~100% (cat, oral); only ~10% transdermal (cat)
Other speciesNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Other species · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Protein binding — ~95% (human data)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Half-life — ~6–10h parent (dog); norfluoxetine (active metabolite) 48–57h (dog), 2 days (Plumb's)
CatNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Cat · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Metabolism — Hepatic → norfluoxetine (active)
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Pharmacokinetics table · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Pregnancy / lactation considerations1
Human FDA category C. Safety not established in breeding/pregnant/lactating dogs per label. Appears safe early pregnancy but caused pulmonary hypertension in experimental animals late in pregnancy. Excreted in milk (20–30% of plasma levels).
Species not recordedNot applicable (NOT_APPLICABLE)1 source record · View provenance
- Species not recorded · Plumb's Veterinary Drug Handbook, 7th ed., p. 545–546; Saunders Handbook of Veterinary Drugs (Papich), 4th ed., p. 339–341 — Pregnancy & Lactation · Not applicable · Not applicable (NOT_APPLICABLE) · Pending clinical review (PROPOSED) · Rule-based
Literature references14
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Owner-Directed Canine Aggression in Thailand: Triggers, Associated Factors and Clinical Interventions.
Study summary not available in the imported record. Open the original citation to review the study.
- Adjunctive Huperzine A for owner-directed aggression associated with hypersensitivity-hyperactivity syndrome in a dog: a case report.
Study summary not available in the imported record. Open the original citation to review the study.
- Concurrent Use of Tasipimidine Oral Solution and Fluoxetine in Dogs.
Study summary not available in the imported record. Open the original citation to review the study.
- Evaluation of a Young Dog for Escalating Aggression Toward Both Familiar and Unfamiliar People.
Study summary not available in the imported record. Open the original citation to review the study.
- An unwanted prescription: Trace fluoxetine exposure disrupts the enteric nervous system, gut-liver axis and somatic growth in zebrafish (Danio rerio).
Study summary not available in the imported record. Open the original citation to review the study.
Sources: PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration; Perrin C, Seksel K, Landsberg GM. Appendix: Drug Dosage Chart. Vet Clin Small Anim 2014;44:629-632.; Plumb DC. Plumb's Veterinary Drug Handbook. 7th ed. PharmaVet Inc; 2011.