Table of Contents
Introduction
Drug-induced liver injury is one of the important causes of liver damage. Many prescription medicines, over-the-counter drugs, and herbal products are known to have the potential to harm the liver. In some cases, drug-related liver damage can be severe and may lead to Acute liver failure, requiring a liver transplant or even becoming life-threatening. Fortunately, such serious reactions are rare, but it is important to use medicines responsibly and under medical guidance. Early recognition of drug-induced liver damage is important. Stopping the medicine promptly can help prevent more serious complications.
Understanding Drug-Induced Liver Injury

- Drug-induced liver injury is liver or biliary system damage caused by medicines, herbal products, or dietary supplements.
- The risk and pattern of liver damage may vary geographically, depending on local disease patterns, treatment practices, and commonly used medicines or traditional remedies.
Types of Drug-Induced Liver Injury

Idiosyncratic
- Occurs in very few people: about 1 in 1,000 to 1 in 1 million exposed individuals.
- Usually unpredictable and not clearly dose-dependent.
- Symptoms may develop weeks to months later, depending on the drug and mechanism.
Direct (Intrinsic)
- Predictable and dose-dependent.
- Can affect many exposed individuals when a threshold dose or duration of exposure is exceeded.
- Symptoms usually appear within hours to days.
- Severity generally depends on the dose taken.
Indirect
- A medicine may not damage the liver directly but can cause liver injury indirectly.
- for example by changing the immune response or reactivating a hidden infection such as hepatitis B.
- Generally not dose-dependent, similar to idiosyncratic.
- Usually develops after a week to a month.
Risk Factors

- Certain patient, lifestyle, and drug-related factors may increase the risk:
- Age: Children and older adults may be more susceptible.
- Gender: Some forms may occur more frequently or be more severe in women.
- Health conditions: Hepatitis B or C, obesity, diabetes, and fatty liver disease may increase risk.
- Alcohol: Heavy alcohol use can increase the risk of liver damage.
- Nutrition: Malnutrition or overnutrition may contribute.
- Multiple medicines: Drug interactions can increase risk.
- Genetics: Certain genetic factors may increase susceptibility.
- Gut microbiota: Changes in gut bacteria may also influence liver damage.
Classic example of direct liver injury
- Paracetamol (acetaminophen) is a common medicine used for pain and fever.
- It is a classic example of a medicine that can cause liver damage when taken in excessive doses.
- Paracetamol overdose may be accidental or intentional.
- Severe overdose can lead to acute liver failure and, in some cases, the need for a liver transplant.
- Many combination medicines also contain paracetamol, increasing the risk of accidental overdose.
- Always check medicine labels before taking more than one product containing paracetamol.
Common causes of idiosyncratic Liver Injury in India
The idiosyncratic form constitutes ~99% of all liver damage cases in India. The common causes are as listed below.
Anti-Tuberculosis Drugs
- Anti-Tuberculosis Drugs are the Leading cause of drug-induced liver damage and acute liver failure in India.
- Usually occurs within the first 2 months of treatment.
- The widespread use of combination anti-tuberculosis therapy, particularly isoniazid, rifampicin, and pyrazinamide, increases the risk of liver toxicity
- Drug interactions, high doses, malnutrition, and Genetic factors may contribute.
Note: In India, acute hepatitis E should be ruled out before diagnosing drug-induced liver injury, as it can cause similar liver abnormalities.
Traditional and Complementary Medicines
- Ayurveda, Unani, Siddha, and Homeopathy are widely used in India—and sometimes taken alongside modern medicines.
- But “natural” or traditional does not always mean risk-free. Some preparations may contain undisclosed ingredients, contaminants, or heavy metals that can potentially harm the liver.
Antiepileptic Drugs
- Older antiepileptics such as phenytoin, carbamazepine, and phenobarbitone can cause liver damage.
- However, with the greater use of newer drugs with a better liver safety profile, the incidence of liver damage is decreasing.
Non-Tuberculosis Antimicrobials
- Non-Tuberculosis antimicrobials constitute the fourth-largest cause of liver damage.
- The top three drugs in this group are:
Causes of Indirect Liver Injury
- Indirect liver injury can occur with some cancer medicines, including immunotherapies, monoclonal antibodies, and targeted therapies.
- Examples
- Cancer immunotherapy: ipilimumab, nivolumab, pembrolizumab
- Monoclonal antibody Therapy: rituximab
- Targeted cancer medicines: imatinib, lapatinib, regorafenib
Recognizing Drug-Induced Liver Injury
- Liver damage due to drugs often causes no symptoms. If symptoms occur, they can vary from person to person and may include:
- In severe cases, it can lead to liver failure.
Diagnosis of Drug induced liver injury
- There is no single test. Doctors usually diagnose it by:
- Reviewing medicines: Checking which medicines or supplements the person is taking.
- Blood tests: Liver enzymes, bilirubin, international normalized ratio, and complete blood count may be checked.
- Ruling out other causes: Tests may be done for viral hepatitis and autoimmune liver disease.
- Imaging: Ultrasound or MRI may be used to check for other problems.
- Liver biopsy: Usually not needed, but may help when the diagnosis is unclear.
Managing Drug-Induced Liver Injury
- Do not restart the suspected medicine unless advised by a healthcare professional.
- Maintain adequate fluids, nutrition, and electrolyte balance.
- Regularly check liver function tests to track recovery.
- Avoid alcohol.
- Eat a balanced diet.
- Get adequate rest.
- Avoid self-medication and medicines or supplements that may further harm the liver.
Key Takeaways
- Drug-induced liver injury can be caused by prescription medicines, over-the-counter drugs, herbal products, and dietary supplements.
- Anti-tuberculosis drugs are a leading cause of drug-induced liver injury in India.
- Natural or traditional products are not always liver-safe.
- Paracetamol overdose is a classic example of predictable, dose-related liver injury.
- Drug-induced liver injury often causes no symptoms.
- Severe cases can lead to acute liver failure, although this is uncommon.
- Early recognition and appropriate medical management are important.
- Do not self-medicate or restart a suspected medicine without medical advice.
Further Reading
- Hosack, T., Damry, D., & Biswas, S. (2023). Drug-induced liver injury: A comprehensive review. Therapeutic Advances in Gastroenterology, 16, 17562848231163410. https://doi.org/10.1177/17562848231163410
- Wang, Y., & Xie, W. (2023). Drug-induced liver injury: An overview and update. Gastroenterology & Endoscopy, 1(2), 102–109. https://doi.org/10.1016/j.gande.2022.11.005
- Kozielewicz, D. M., Stalke, P., & Skrzypek, J. (2025). Drug-induced liver injury. Part I: Classification, diagnosis and treatment. Clinical and Experimental Hepatology, 11(1), 25–33. https://doi.org/10.5114/ceh.2025.148329
- Devarbhavi, H. (2021). Drug-induced liver injury unique to India. Clinical Liver Disease, 18(3), 108–110. https://doi.org/10.1002/cld.1120
- Tiwari, V., Shandily, S., Albert, J., Mishra, V., Dikkatwar, M., Singh, R., Sah, S. K., & Chand, S. (2025). Insights into medication-induced liver injury: Understanding and management strategies. Toxicology Reports, 14, 101976. https://doi.org/10.1016/j.toxrep.2025.101976
- Francis, P., & Navarro, V. J. (2024). Drug-induced hepatotoxicity. In StatPearls. StatPearls Publishing. NCBI Bookshelf
- Ozturk, N. B., Uskudar, E., Toruner, M. D., Simsek, C., & Gurakar, A. (2025). Drug-induced liver injury: Diagnosis, management and the role of liver transplantation. Hepatology Forum, 6(2), 72–76. https://doi.org/10.14744/hf.2024.2024.0003
- Rotundo, L., & Pyrsopoulos, N. (2020). Liver injury induced by paracetamol and challenges associated with intentional and unintentional use. World Journal of Hepatology, 12(4), 125–136. https://doi.org/10.4254/wjh.v12.i4.125
