Statistical Analysis of Zorbium™ Adverse Event Reports as of 3.30.25
Executive Summary
This analysis examines 65 reported cases of adverse events associated with Zorbium™ (transdermal buprenorphine) administration collected through the zorbiumlawsuit.com website from March 2024 to March 2025. While self-reported data has inherent limitations, the consistency of reported symptoms and outcomes across diverse cases suggests concerning patterns that warrant further investigation.
Key Findings:
- High Fatality Rate: 32 of 65 cases (49.2%) resulted in death
- Off-label Use: 32 of 65 cases (49.2%) involved off-label use of Zorbium™ (not for post-surgical pain)
- Age-related Risk: Senior animals (8+ years) represented 70.8% of reported cases
- Consistent Symptom Pattern: A distinctive constellation of symptoms appears across reports:
- Neurological effects (dilated pupils, disorientation, hallucinations)
- Inability to sleep (often for 24-72 hours)
- Respiratory distress
- Loss of appetite and thirst
- Agitation or fear behaviors
- Timing of Death: In fatal cases, death typically occurred 1-5 days after administration
1. Demographics Analysis
1.1 Species Distribution
- Cats: 64 cases (98.5%)
- Dogs: 1 case (1.5%)
1.2 Age Distribution
| Age Group | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| <3 years | 6 | 9.2% | 3 | 50.0% |
| 3-7 years | 13 | 20.0% | 6 | 46.2% |
| 8-12 years | 15 | 23.1% | 6 | 40.0% |
| 13-16 years | 17 | 26.2% | 10 | 58.8% |
| >16 years | 14 | 21.5% | 7 | 50.0% |
Observation: While all age groups show significant fatality rates, animals over 13 years appear slightly more vulnerable (55.9% fatality rate vs. 43.8% in younger animals).
1.3 Gender Distribution
- Male: 39 (60.0%)
- Female: 26 (40.0%)
1.4 Breed Distribution
| Breed Type | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| Domestic Shorthair/Mixed | 43 | 66.2% | 21 | 48.8% |
| Specific Breeds | 22 | 33.8% | 11 | 50.0% |
Specific Breeds Represented:
- Siamese/Ragdoll/Himalayan: 5 cases (3 fatal)
- Maine Coon/Norwegian Forest Cat: 3 cases (1 fatal)
- Persian: 1 case (0 fatal)
- Chihuahua (dog): 1 case (0 fatal)
- Other/Mixed Specific Breeds: 12 cases (7 fatal)
Observation: Breed does not appear to be a significant factor in adverse outcomes, with domestic shorthair/mixed breed cats and purebreds showing similar fatality rates.
1.5 Coat Color Distribution
| Coat Color | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| Black/Black and White (Tuxedo) | 17 | 26.2% | 10 | 58.8% |
| Orange/Ginger | 9 | 13.8% | 5 | 55.6% |
| Gray/Silver/Blue | 12 | 18.5% | 4 | 33.3% |
| Tortoiseshell/Calico | 5 | 7.7% | 3 | 60.0% |
| White/Predominantly White | 7 | 10.8% | 3 | 42.9% |
| Brown/Tab | 11 | 16.9% | 5 | 45.5% |
| Other/Not Specified | 4 | 6.2% | 2 | 50.0% |
Observation: While the sample size is too small to draw definitive conclusions, black/tuxedo cats and tortoiseshell/calico cats show somewhat higher fatality rates in this dataset. This pattern is interesting given previous research suggesting associations between coat color and certain health or behavioral predispositions in cats.
1.6 Weight Distribution
| Weight Group | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| <6 lbs | 10 | 15.4% | 5 | 50.0% |
| 6-10 lbs | 27 | 41.5% | 14 | 51.9% |
| 10-15 lbs | 20 | 30.8% | 9 | 45.0% |
| >15 lbs | 8 | 12.3% | 4 | 50.0% |
Observation: No clear correlation between weight and fatal outcomes is apparent in this dataset.
2. Administration Patterns
2.1 Reason for Administration
| Reason | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| Surgery-related | 25 | 38.5% | 11 | 44.0% |
| Off-label use | 32 | 49.2% | 18 | 56.3% |
| Unknown/Not specified | 8 | 12.3% | 3 | 37.5% |
Observation: Off-label use cases had a higher fatality rate (56.3%) compared to surgery-related cases (44.0%), though both rates are alarmingly high.
2.2 Timing of Administration (for Surgery Cases)
| Timing | Number of Cases | Percentage |
|---|---|---|
| Pre-Surgery | 4 | 16.0% |
| Post-Surgery | 19 | 76.0% |
| Unknown Timing | 2 | 8.0% |
2.3 Dosage Analysis
| Dosage Color | Number of Cases | Percentage | Fatal Cases | Fatality Rate |
|---|---|---|---|---|
| Green (up to 16.5 lbs) | 29 | 44.6% | 14 | 48.3% |
| Pink (up to 6.6 lbs) | 11 | 16.9% | 6 | 54.5% |
| Unknown/Not specified | 25 | 38.5% | 12 | 48.0% |
Observation: There is no clear relationship between reported dosage color and fatality rate in this dataset.
3. Symptom Analysis
3.1 Most Frequently Reported Symptoms
| Symptom | Frequency | Percentage |
|---|---|---|
| Not eating/loss of appetite | 42 | 64.6% |
| Not drinking/dehydration | 38 | 58.5% |
| Dilated pupils | 35 | 53.8% |
| Inability to sleep/insomnia | 34 | 52.3% |
| Agitation/restlessness | 33 | 50.8% |
| Disorientation/confusion | 31 | 47.7% |
| Respiratory distress | 23 | 35.4% |
| Hiding behavior | 22 | 33.8% |
| Neurological symptoms (twitching, seizures) | 21 | 32.3% |
| Aggression/behavioral changes | 20 | 30.8% |
| Cardiac/heart issues | 15 | 23.1% |
| Urinary problems | 14 | 21.5% |
3.2 Distinctive Symptom Patterns
Multiple distinct patterns emerge from the symptom data:
Neurological Pattern:
- Dilated pupils
- Disorientation/confusion
- Hallucinations (staring at walls/ceiling)
- Twitching or seizures
- Agitation/restlessness
Physiological Pattern:
- Inability to sleep (often for 24-72 hours)
- Not eating or drinking
- Respiratory distress
- Cardiac issues
Behavioral Pattern:
- Hiding
- Aggression or fear behaviors
- Personality changes
- Hypervigilance
Observation: The consistency of these symptom patterns across diverse cases suggests a common physiological reaction rather than random adverse events.
4. Timeline Analysis
4.1 Time to Death (Fatal Cases)
| Timeframe | Number of Cases | Percentage |
|---|---|---|
| <24 hours | 7 | 21.9% |
| 1-3 days | 18 | 56.3% |
| 4-7 days | 5 | 15.6% |
| >7 days | 2 | 6.3% |
Observation: Most fatal outcomes (78.2%) occurred within 3 days of Zorbium administration, aligning with the drug’s expected duration of action (4 days).
4.2 Timing of Symptom Onset
| Timeframe | Number of Cases | Percentage |
|---|---|---|
| Immediate (<2 hours) | 18 | 27.7% |
| Within 24 hours | 41 | 63.1% |
| 24-48 hours | 6 | 9.2% |
Observation: Most adverse reactions began within 24 hours of administration (90.8%), with many occurring almost immediately.
5. Notable Patterns in Case Reports
5.1 Off-Label Use
Almost half (49.2%) of reported cases involved off-label use, including:
- Treatment for arthritis/pain management
- Constipation
- Urinary issues
- General discomfort
- Stress
5.2 Informed Consent Concerns
- 100% of cases reported “No” to being informed about potential side effects. In California and New York, this is illegal.
- Multiple reports specifically mentioned they would have declined Zorbium™ had they known the risks
- Several reports mentioned veterinarians describing side effects as “rare” even after adverse events occurred
5.3 Recovery Patterns
For non-fatal cases that reported recovery information:
- Duration of symptoms typically matched the drug’s 4-day expected duration
- Some animals experienced persistent behavioral changes even after apparent physical recovery
- Several cases reported long-term neurological effects
6. Scientific Implications
6.1 Potential Mechanisms
Based on the reported symptoms, several physiological mechanisms could be involved:
- CNS Excitation: The pattern of insomnia, agitation, and dilated pupils suggests central nervous system excitation rather than the expected opioid-related sedation.
- Respiratory Depression: A known opioid effect, but potentially exacerbated in the transdermal formulation or certain animal populations.
- Autonomic Dysfunction: The combination of cardiovascular, respiratory, and urinary symptoms suggests potential autonomic nervous system dysregulation.
- Altered Metabolism: The consistency of the pattern across different weights, ages, and breeds suggests possible issues with the drug’s metabolism or clearance.
6.2 Risk Factors
While the dataset shows high fatality rates across all demographics, potential risk factors include:
- Advanced Age: Slightly higher fatality rates in animals over 13 years (55.9% vs. 43.8%)
- Off-label Use: Higher fatality rate (56.3% vs. 44.0% for surgical use)
- Pre-existing Conditions: Several reports mentioned kidney disease or other health issues
7. Limitations of This Analysis
This analysis has several important limitations:
- Self-reported Data: Data collected via self-reporting may be biased toward more severe outcomes
- Selection Bias: Pet owners who experienced adverse events are more likely to visit the website and submit reports
- Lack of Denominator: Without knowing the total number of Zorbium™ administrations, true incidence rates cannot be calculated
- Verification Challenges: Medical details cannot be independently verified
- Limited Dog Data: With only one dog case reported, species-specific patterns cannot be reliably established
- Incomplete Follow-up: Some cases were reported while the animal was still experiencing adverse effects, without information on ultimate outcome. Some animals reported as surviving may have later died, while others may have developed long-term health issues not captured in the initial report
- Time Period Limitations: Reports span approximately one year, which may not capture longer-term patterns or delayed effects
8. Conclusions
Despite the limitations of self-reported data, the consistency of symptom patterns, high fatality rate, and clear timeline relationships strongly suggest Zorbium™ is associate with serious adverse events in a subset of animals. Of particular concern:
- The nearly 50% fatality rate in reported cases
- The high proportion of off-label use
- The distinctive neurological and physiological symptom pattern
- The rapid progression from administration to death in fatal cases
- The apparent lack of informed consent about potential risks
The patterns observed in this dataset warrant urgent investigation into:
- The drug’s safety profile in different age groups
- Appropriate dosing based on more factors than just weight
- Clear contraindications for off-label use
- Potential interactions with pre-existing conditions
- Mechanisms to identify animals at higher risk for adverse events
Most importantly, this analysis underscores the need for more transparent communication about potential risks so pet owners can make truly informed decisions about their animals’ care
This section was made with the assistance of Generative AI.