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 Table of Contents    
Year : 2021  |  Volume : 63  |  Issue : 2  |  Page : 206-207
Adverse drug reactions with naltrexone: Experience from an addiction treatment center

Department of Psychiatry and NDDTC, AIIMS, New Delhi, India

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Date of Submission08-Feb-2020
Date of Decision01-Apr-2020
Date of Acceptance20-Apr-2020
Date of Web Publication14-Apr-2021

How to cite this article:
Sarkar S, Addagadda SS, Bhatia G, Chadda RK. Adverse drug reactions with naltrexone: Experience from an addiction treatment center. Indian J Psychiatry 2021;63:206-7

How to cite this URL:
Sarkar S, Addagadda SS, Bhatia G, Chadda RK. Adverse drug reactions with naltrexone: Experience from an addiction treatment center. Indian J Psychiatry [serial online] 2021 [cited 2021 Jul 30];63:206-7. Available from:


Naltrexone is an opioid antagonist that has been used for the long-term treatment of opioid dependence and alcohol dependence. As with other medications, this too has its own profile of adverse drug reactions (ADRs). Understanding the nature and pattern of ADRs in a treatment facility can help to inform clinicians in making decisions. The National Drug Dependence Treatment Centre, Ghaziabad has provided an opportunity to closely examine the ADRs related to medications used in the treatment of addictive disorders.[1],[2] We sought to analyze the ADRs encountered with naltrexone in a period of about 3 years (August 2016 to December 2019), given the lack of such literature on this topic.[3],[4]

This record-based audit was based on 219 ADRs reported by doctors and nurses. The mean age of the sample was 32.38 (±9.67) years. All patients were males. The profile of ADRs encountered is presented in [Table 1]. While decreased appetite was the most common ADR, other common ones were vomiting and dizziness. ADRs according to system organ classification (MedDRA) suggested gastrointestinal disorders to be the most common (n = 100, 45.7%). According to WHO UMC causality assessment, 157 reports were classified as “possible,” 48 were “probable,” 13 were “certain,” and 1 was “unclassified.” Two hundred and nine (95.4% of the ADRs) were labeled (i.e., mentioned previously in package insert), and they were non-labeled in ten (6.6%). A total of 75 patients were reported as “recovered” (n = 75, 34.3%), and it was “unknown” in 144 (65.7%).
Table 1: Adverse drug reactions reported (n=219) in patients who used naltrexone

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The profile of ADRs suggests that decreased appetite was the most common complaint in patients who receive naltrexone, while previous literature suggested nausea and weakness as the most common ADRs.[3],[4] Lack of appetite has implications for trajectory of recovery of patients with alcohol and opioid dependence, both of which are associated with weight loss during the course of active dependence, and weight gain is expected during recovery as patient cease substance use. Furthermore, treating clinicians should focus on gastrointestinal and nervous/psychiatric organ systems in practice when they prescribe naltrexone for the treatment of addictive disorders.


The authors would like to thank the Pharmacovigilance Programme of India.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

   References Top

Dhagudu NK, Erravalli A, Sarkar S, Chadda RK. Tramadol-related adverse drug reactions at an addiction psychiatry setting: A cross-sectional analysis. Indian J Psychol Med 2019;41:593-5.  Back to cited text no. 1
[PUBMED]  [Full text]  
Thota A, Thota P, Kalaiselvan V, Sarkar S, Singh GN. Pharmacovigilance in drugs used in the treatment of drug dependence. Indian J Psychiatry 2017;59:393-5.  Back to cited text no. 2
[PUBMED]  [Full text]  
Croop RS, Faulkner EB, Labriola DF. The safety profile of naltrexone in the treatment of alcoholism. Results from a multicenter usage study. The Naltrexone Usage Study Group. Arch Gen Psychiatry 1997;54:1130-5.  Back to cited text no. 3
Sinclair JM, Chambers SE, Shiles CJ, Baldwin DS. Safety and tolerability of pharmacological treatment of alcohol dependence: comprehensive review of evidence. Drug Saf 2016;39:627-45.  Back to cited text no. 4

Correspondence Address:
Siddharth Sarkar
Department of Psychiatry and NDDTC, AIIMS, New Delhi
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/psychiatry.IndianJPsychiatry_94_20

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  [Table 1]