Cannabis Safety in Real Life: Lessons from Literature Monitoring

Cannabis and its products, particularly cannabis oil containing CBD, are becoming increasingly common in modern therapeutic practice. People use them to relieve pain, anxiety, inflammation, and sleep disorders. As their use grows, questions about cannabis safety in real life are becoming increasingly important.

The prevailing belief holds that CBD is “natural,” “non-psychoactive,” and “well tolerated.” While this is often true in controlled clinical contexts, pharmacovigilance specialists know a critical fact: well-tolerated does not mean risk-free. Real-world use, especially with polypharmacy, comorbidities, and unregulated products, complicates the safety profile. As cannabis oil use expands outside of medical supervision, new challenges emerge for pharmacovigilance. And this is where literature monitoring plays a critical role in understanding real-world risks.

The Growing Use of CBD Worldwide

The global use of CBD and cannabis oil has expanded dramatically in recent years. Market research estimates that the cannabidiol industry reached around USD 10.68 billion in 2025 and is expected to grow to nearly USD 31 billion by 2033, with an average annual growth rate of 13.7% from 2026 to 2033. This rapid expansion is fueled by increasing public interest in the potential health benefits of CBD for conditions such as chronic pain, anxiety, insomnia, and inflammation, as well as a growing preference for natural, plant-based wellness products. With such widespread adoption, monitoring the real-world safety of these products has become more critical than ever.

Understanding Cannabis Safety in Real Life

Research indicates that cannabis and CBD may raise liver enzyme levels. CBD also interacts with CYP450 enzymes, potentially affecting the concentrations of other drugs.

Real-world clinical practice, however, is far more complex. Patients often take multiple medications simultaneously, some with hepatotoxic potential. Doses may vary, and products may lack standardisation. In these circumstances, establishing causality is exceptionally challenging.

Well-documented clinical cases in the literature help pharmacovigilance move from general assumptions to actionable safety signals, offering real-world insights into cannabis safety.

Severe Liver Injury Case and Cannabis

During literature monitoring using the DrugCard platform, a notable clinical case was identified. A 45-year-old woman presented to the emergency department with fatigue and mild discomfort in the right hypochondrium. She denied alcohol or illicit drug use.

Two weeks earlier, she had completed a five-day course of flucloxacillin and had taken paracetamol at 1–1.5 g per day for two weeks to relieve pain. She had also been using cannabis oil at 1 ml three to four times daily for 14 days.

Laboratory tests revealed severe liver enzyme elevations, including bilirubin and ALT levels, indicating hepatocellular damage. Paracetamol blood levels were subtoxic, and flucloxacillin had been discontinued two weeks earlier. The injury pattern did not match the typical hepatotoxic profile of these drugs.

After excluding other causes, the team concluded an idiosyncratic drug-induced liver injury, possibly related to cannabis oil. Following discontinuation of cannabis oil, liver function gradually improved.

Why This Case Highlights Cannabis Safety in Real Life

This case shows that even drugs considered well-tolerated can trigger severe reactions. Clinicians face particular challenges in diagnosing liver injury when patients take multiple hepatotoxic agents. Without careful analysis, one might incorrectly attribute the injury to a familiar drug.

The clinical description, laboratory dynamics, and improvement after cannabis oil withdrawal were key to the assessment. Importantly, this case was identified through literature monitoring rather than spontaneous reporting, emphasising the strategic value of systematic review in understanding cannabis safety in real life.

The Role of Literature Monitoring in Cannabis Safety

Pharmacovigilance often treats literature monitoring as routine, but in practice, it serves a strategic function. Physicians often publish clinical cases as case reports, which may not appear in spontaneous reporting systems. These reports often describe atypical drug combinations, complex diagnoses, or emerging risks.

Analysing medical literature systematically allows early detection of safety signals, identification of rare or severe reactions, and understanding of potential drug interactions. For cannabis oil, this monitoring is particularly crucial. Patients may use products without a prescription, and their use may not be documented in medical records. Literature becomes a key source of real-world safety information.

Challenges in Establishing Causality

Diagnosing liver injury is inherently tricky. Drug-induced liver injury (DILI) is a diagnosis of exclusion. Clinicians must rule out viral hepatitis, autoimmune disorders, alcohol-related damage, ischemia, and other drugs.

When patients take multiple hepatotoxic medications, assessment becomes even more challenging. Specialists must determine whether a reaction is a direct toxic effect, an idiosyncratic response, or a CYP450-mediated interaction. Publications often provide essential data on timelines, laboratory dynamics, and outcomes after drug withdrawal, supporting more accurate pharmacovigilance.

Leveraging Technology for Literature Monitoring

The growing volume of scientific publications makes systematic literature monitoring increasingly complex. Platforms like DrugCard help efficiently identify relevant cases. Automated searches do not replace expert evaluation, but they accelerate the discovery of critical publications that can influence safety assessments.

In the case of cannabis oil, literature monitoring enabled the identification of a severe hepatocellular injury that might have otherwise gone unnoticed, reinforcing the importance of vigilance in cannabis safety in real life.

Conclusion

CBD and cannabis oil are often regarded as safe. Many patients do not experience serious problems. However, pharmacovigilance relies on data rather than assumptions.

Each case described in the literature improves understanding of real risks, diagnostic complexity, and potential interactions, particularly when multiple hepatotoxic drugs are involved. Literature monitoring is not a formality; it is a key tool for early signal detection.

In a world where “natural” is often equated with “safe,” pharmacovigilance remains attentive to detail. The medical literature continues to be one of the most important sources of insight into cannabis safety in real life.