A STUDY OF ADVERSE EVENTS OF PSYCHOTROPIC MEDICATIONS ON PATIENTS ADMITTED IN PSYCHIATRY WARD – A NATURALISTIC STUDY

A STUDY OF ADVERSE EVENTS OF PSYCHOTROPIC MEDICATIONS ON PATIENTS ADMITTED IN PSYCHIATRY WARD - A NATURALISTIC STUDY

Anil Dokhale, Vivek Chincholkar, Chinmay Deshpande, Himanshi Shirmali *, Vemparala Subrahmanya Sastry and Sushma Sonavane

Department of Psychiatry, Lokmanya Tilak Municipal Medical College, Mumbai, Maharashtra, India.

ABSTRACT: Background: Psychiatric disorders requiring chronic use of psychotropic drugs can cause a wide range of potential adverse effects that can have life-threatening outcomes if not detected and treated on time. This study is aimed towards monitoring and assessing Adverse Drug Events caused by psychotropic drugs. Methods: A prospective observational study was done among 100 patients in Psychiatry Indoor Patients Department from January 2019 to August 2020 using convenient consecutive consenting samples to perform the tests. Results: The study included 100 psychiatric patients, majority suffering from schizophrenia, followed by bipolar mood disorder, major depressive disorder and obsessive-compulsive disorder. Among antipsychotics, maximum side effects were seen in patients who were on haloperidol and least in patients on olanzapine. Extrapyramidal reactions were most common with haloperidol. Clozapine caused the most sedation and hypersalivation. Among SSRIs, escitalopram had the highest side effects, including the most sexual side effects among all antidepressants. Valproate caused the most side effects, including confusion and more weight gain, tremor, and nausea than lithium. Conclusion: Haloperidol and risperidone caused extrapyramidal symptoms; SSRIs/TCAs led to autonomic effects; and metabolic side effects were common with second-generation antipsychotics, SSRIs, TCAs, and SNRIs. Though statistically significant, these effects lacked clinical relevance.

Keywords: Psychotropics, side effects, Adverse events, Antipsychotics, Antidepressants

INTRODUCTION: Antidepressants, anti-psychotics, and mood stabilizers make up a significant portion of commonly prescribed psychotropic medications. Each class is associated with its own profile of adverse effects.

Selective serotonin reuptake inhibitors (SSRIs) are frequently linked to symptoms such as headache, sedation, insomnia, nausea, sexual dysfunction, and hyponatremia ¹.

Tricyclic antidepressants (TCAs) often lead to side effects like dry mouth, constipation, sedation, orthostatic hypotension, and cardiac arrhythmias ². Mirtazapine is known for causing weight gain and sedation ³. First-generation antipsychotics (FGAs) are commonly associated with extrapyramidal side effects ⁴. Antipsychotic medications, in general, have been implicated in the development of obesity and metabolic syndrome, both of which increase the risk of cardiovascular disease and type 2 diabetes contributing factors to the reduced life expectancy observed in this patient population ^{5, 6}. Among mood stabilizers, lithium is notable for potential side effects such as increased urine output, hypothyroidism, hyperparathyroidism, tremors, cognitive slowing, and elevated serum calcium levels ⁷.

These side effects can have serious outcomes if not detected and treated on time. As a tertiary care centre and the indoor unit, we routinely prescribe different classes of psychotropic medications to our patients. Therefore, the present study was undertaken to investigate the frequency and types of adverse events reported in indoor patients receiving psychotropic medications and to study the correlation of these side effects with various demographic and phenomenological factors.

METHODS: A prospective observational study was done among 100 patients in Psychiatry Indoor Patients Department from January 2019 to August 2020 using convenient consecutive consenting samples to perform the tests.

The study was carried out after obtaining Institutional Ethics committee approval (IEC/928/18) and taking written informed consent from the participants. 100 patients above 18 years admitted in psychiatry ward and newly started on psychotropics were included. Also those patients who had stopped medications for more than 3 months and were restarted medications were also included. Those patients who did not have reliable informant, or discharged before 7 days and having medical comorbidities were excluded.

Semi-structure proforma was used to collect demographic and phenomenological details and also to assess the side effects patients had with use of psychotropic medications. Details regarding side effects were recorded at 7^th day of admission and then every 7 days till discharge.  Data collected was entered in excel sheet and subjected to analysis using computerized software.

RESULTS: Table 1 describes the demographic details of study population. Diagnosis of these patients was Schizophrenia and related disorders in 35% followed by bipolar mood disorder in 33%. 21% of them suffered from Major Depressive Disorder and 11% had Obsessive and Compulsive Disorder.

In our study, the mean age of patients was 32.39 years with a standard deviation of 6.70 years. The gender distribution revealed a slight male predominance with 55% males as opposed to 45% females. Our study assessed the effect of 15 medications, distributed among antidepressants, antipsychotics, and mood stabilizers.

TABLE 1: DEMOGRAPHIC DETAILS OF STUDY SAMPLE

Table 2 shows that among antipsychotics haloperidol most frequently used drug (n=27) followed by olanzapine (n=25), risperidone (n=21), and clozapine (n=17).

Maximum side effects were seen in patients who were on haloperidol and least in patients on olanzapine. Extrapyramidal reactions were maximum with haloperidol. Sedation and hypersalivation was seen maximum with clozapine. Risperidone had the maximum sexual side effects. Increased appetite was seen with both risperidone and olanzapine.

TABLE 2: SIDE EFFECTS WITH ANTIPSYCHOTICS

In our study, among SSRIs, most frequently used escitalopram (n=33), followed by paroxetine (n=11), fluoxetine (n=11) and sertraline (n=5). Amongst SSRI maximum side effects were seen with escitalopram. Sexual side effects were maximum with escitalopram amongst all antidepressants. Overall maximum side effects were with mirtazapine. Sedation ad constipation was seen maximum with mirtazapine Table 3.

TABLE 3: SIDE EFFECTS WITH ANTIDEPRESSANTS

Table 4 shows that maximum side effects were seen with valproate. Confusion was the side effect seen only in patients on valproate. Weight gain, tremor and nausea was seen more commonly with valproate than lithium. Polyuria was seen only in patients on lithium. Oxcarbazepine had side effects of headache, nausea, dizziness and diminished sexual desire.

TABLE 4: SIDE EFFECTS WITH MOOD STABILIZERS

DISCUSSION: Our study was unique in that, unlike earlier research which focused on a single diagnosis or medication group such as the studies by Hergovich et al., Tham et al., Demet et al., and Tielens et al. ⁸, which included only patients with major depressive disorder our study encompassed a broader clinical spectrum by including individuals with multiple psychiatric diagnoses.

The broader inclusion of multiple drug classes distinguishes our study from previous research, such as that by Tham et al., Demet et al., and Tielens et al .⁸, which focused on individual drugs or specific drug groups like venlafaxine, mirtazapine, and paroxetine, respectively. Notably, the dosages used in our study remained within the FDA-approved range.

Our study highlighted the incidence and nature of adverse drug events which were associated with psychotropic medication so that a correlation between the adverse drug events and the pattern of psychotropic use could be established. It was noticed that the adverse events were more pronounced from 2 weeks after starting medications. Igor Schillevoort et al. study revealed that patients on risperidone and olanzapine had lower risks of EPS when compared to haloperidol in the majority of subgroups with similar treatment histories ⁹. These findings are consistent with our own. Patients on risperidone who had previously experienced EPS, however, did not exhibit this. Our study did not take into account EPS's prior history. In our study, erectile dysfunction was observed in 24% of patients treated with risperidone and 15% of those on haloperidol, aligning with previous findings. Bobes et al. reported lower sexual dysfunction rates with quetiapine (18.2%, mean dose 360.5 mg/day) compared to risperidone (43.2%, 5.3 mg/day), haloperidol (38.1%, 10.6 mg/day), and olanzapine (35.3%, 13.5 mg/day) ¹⁰. Clozapine was associated with improved sexual function, including orgasm frequency and satisfaction, when compared to conventional antipsychotics ¹¹. Another study found sexual dysfunction prevalent in patients on typical neuroleptics, regardless of prolactin levels, though hyperprolactinemia appeared to be a major contributing factor, particularly in both genders ¹². 76% of clozapine-using trial participants experienced hypersalivation. 92% of subjects exhibited hypersalivation brought on by clozapine ¹³. Alpha-2 antagonism, clozapine agonism at the M4 muscarinic receptor, and unopposed beta adrenoceptor activity consequent to alpha-1 and alpha-2 antagonism are some of the hypothesized causes and reduced peristalsis of the larynx ¹⁴. The weight increase pattern we saw with antipsychotics is consistent with a research by Jan Volavka et al. that found that the average weight gains (in kilograms) were 4.2 for clozapine, 5.4 for olanzapine, 2.3 for risperidone, and 0.2 for haloperidol. Research indicates that H1 Blockade is the cause of metabolic adverse effects ¹⁵.

Most research have evaluated sexual dysfunction with SSRIs, however because study methods differ greatly, it is challenging to interpret the results. The tiny sample size of those studies prevented a firm conclusion; however previous research has not demonstrated substantial differences between one specific class of SSRI-related sexual dysfunction. We believe that as the sample size is larger, certain variations across SSRIs may become apparent. Of the patients taking fluoxetine, 45% experienced nausea. Additionally, it has been documented that fluoxetine reduces appetite and food intake in rats and humans in a dose-dependent manner, resulting in weight loss. It is unknown how SSRIs cause gastrointestinal side effects, but elevated serotonin levels in the brain and GIT are probably to blame.

The enterochromaffin cells of the GIT contain 90% of the body's serotonin stores, hence it is not surprising that these medications negatively impact this system. Hyper Serotonin syndromes, like those brought on by cancerous tumors, are also known to cause effects on the gastrointestinal tract, such as anorexia, nausea, vomiting, and diarrhea ¹⁶. Paroxetine tends to be more sedating and constipating in some patients, perhaps due to its high anticholinergic activity. Grosu et al. recently showed a dosage association between valproate and weight gain liability in this issue of the Journal. By further quantifying dose-related risk (approximately ½ of 1% weight increase per 500 mg dose, and especially when total dosing is above 1,300 mg/d), their retrospective, naturalistic study of 215 patients with a variety of major psychiatric disorders during a year of valproate treatment adds nuance to previous studies of valproate weight gain. For males, but not for women, weight increase was substantially correlated with the length of treatment and the dosage of valproate. Although it remained throughout the research period, the most rapid weight increase happened in the first three months ¹⁷.

Within a month of beginning treatment, valproate tremor developed, which was comparable to essential tremor. It existed while at rest and was made worse by movement or antigravity posture. Plasma valproate levels and tremor intensity did not correlate well, however tremor typically manifested at concentrations exceeding 750 mg daily. In research by B. J. Karas, this tremor was observed in 20 out of 25 individuals ¹⁸.

With rates as high as 70% in long-term patients, excessive thirst and urination (polyuria and polydipsia) are regularly shown to be among the most common side effects related with lithium. Lithium interferes with the collecting tubules' ability to produce cyclic adenosine monophosphate in response to stimulation from antidiuretic hormones, which is how it causes polyuria. As a result, the kidneys' ability to retain free water is diminished, which impairs concentration and causes urine to become too diluted ⁷. About 25% of treated people have lithium tremor ¹⁹.

CONCLUSION: Extra pyramidal side effects like akathisia and dystonia were seen with use of haloperidol and risperidone. Autonomic side effects like dry mouth, constipation, orthostatic hypotension, diminished sexual desire, erectile dysfunction were seen with use of SSRIs/TCAs.

Increase salivation, sleepiness, weight gain, increased appetite, commonly occurs with second generation antipsychotics, SSRIs, TCAs and SNRIs. Although statistically significant changes were noted with use of psychotropic drugs, none had clinical manifestations hence changes were not clinically significant.

Limitations of the Study: It was carried out in a tertiary care center and hence the results cannot be generalized. Also long term follow up was not done to check for late onset side effects.

ACKNOWLEDGEMENTS: Nil

CONFLICTS OF INTEREST: Nil 

REFERENCES:

1. Rosenblum D and Elias H: Selective Serotonin Reuptake Inhibitors (SSRIS). Basic Anesthesia Review 2024; 397.
2. Munoz-Acuna R and Munoz-Acuna R: Tricyclic antidepressants. Basic Anesth Rev 2024; 3: 395.
3. Alam MT, Sarkar AA, Khan MZ, Ahmed HU, Mamun AA, Hasan M, Hossain R, Zahangir TI, Afroz N, Lopa AR and Abbassi NA: Therapeutic effects and safety of mirtazapine for insomnia in major depressive disorder: findings from a 6-week open-label pre-and post-intervention study. Neuropsychobiology 2025.
4. Ali T, Sisay M, Tariku M, Mekuria AN and Desalew A: Antipsychotic-induced extrapyramidal side effects: A systematic review and meta-analysis of observational studies. PloS one 2021; 16(9): 0257129.
5. Iqbal S, McDeavitt K, Han JY, Li BT, Beal LL, Zaidi M and Shah AA: Metabolic issues side effects of antipsychotics. Psychiatric Annals 2025; 55(1): 19-23.
6. Fonseca M, Carmo F and Martel F: Metabolic effects of atypical antipsychotics: Molecular targets. Journal of Neuroendocrinology 2023; 35(12): 13347.
7. Gitlin M and Bauer M. Lithium: current state of the art and future directions. International Journal of Bipolar Disorders 2024; 12(1): 40.
8. Hergovich N, Aigner M, Eichler HG, Entlicher J, Drucker C and Jilma B: Paroxetine decreases platelet serotonin storage and platelet function in human beings. Clinical Pharmacology & Therapeutics 2000; 68(4): 435-42.
9. Schillevoort I, De Boer A, Herings RM, Roos RA, Jansen PA and Leufkens HG: Risk of extrapyramidal syndromes with haloperidol, risperidone, or olanzapine. Annals of Pharmacotherapy 2001; 35(12): 1517-22.
10. Bobes J, Garc A-Portilla MP, Rejas J, Hern Ndez G, Garcia-Garcia M, Rico-Villademoros F and Porras A: Frequency of sexual dysfunction and other reproductive side-effects in patients with schizophrenia treated with risperidone, olanzapine, quetiapine, or haloperidol: the results of the EIRE study. Journal of Sex & Marital Therapy 2003; 29(2): 125-47.
11. Montejo AL, de Alarcón R, Prieto N, Acosta JM, Buch B and Montejo L: Management strategies for antipsychotic-related sexual dysfunction: a clinical approach. Journal of Clinical Medicine 2021; 10(2): 308.
12. Arabaci İ, Ozkan B and Karakaş Uğurlu G: A look at the concept of “sexual dysfunction” through psychotropic drugs: a review. Discover Public Health 2025; 22(1): 1-8.
13. Sanagustin D, Martin-Subero M, Hogg B, Fortea L, Gardoki I, Guinart D, Roldán M, Angelats M, Cerro L, Navas D and Jiménez JD: Prevalence of clozapine-induced sialorrhea and its effect on quality of life. Psychopharmacology 2023; 240(1): 203-11.
14. Prljača E, Bećirović E, Hasanović M, Pajević I and Brigić A: Clozapine-induced hypersalivation treated with sulpiride-is it a solution?. Psychiatria Danubina 2021; 33(4): 1230-2.
15. Miedlich SU and Lamberti JS: Connecting the dots: Understanding and addressing the metabolic impact of antipsychotic and antidepressant medications. Annals of the New York Academy of Sciences 2025; 1546(1): 35-57.
16. McManis PG and Talley NJ: Nausea and vomiting associated with selective serotonin reuptake inhibitors: incidence, mechanisms and management. CNS Drugs 1997; 8(5): 394-401.
17. Goldberg JF: Valproate and Weight Gain: A New Look at an Old Problem. The Journal of Clinical Psychiatry 2024; 85(2): 53864.
18. Zhang CQ, He BM, Hu ML, Sun HB. Risk of valproic acid-related tremor: a systematic review and meta-analysis. Frontiers in Neurology 2020; 11:
19. FRACGP VN: Tremor: A systematic approach. Australian Journal of General Practice 2024 Dec 1; 53: 61-7.
    

    ---

    How to cite this article:

    Dokhale A, Chincholkar V, Deshpande C, Shirmali H, Sastry VS and Sonavane S: A study of adverse events of psychotropic medications on patients admitted in psychiatry ward - a naturalistic study. Int J Pharm Sci & Res 2026; 17(2): 654-59. doi: 10.13040/IJPSR.0975-8232.17(2). 654-59.

    ---

    All © 2026 are reserved by International Journal of Pharmaceutical Sciences and Research. This Journal licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported License.