Impact Of Pharmacovigilance in Polycystic Ovary Syndrome and Identification of Its Risk Factors: In Ernakulam District [Four Regions: Perumbavoor, Cherukunnam, Odakkali, Nellikuzhi]

Alphonsa Mathew , Aleena Jose, Anuja S. Babu, Sampoornna S., Sreekutty S., Dr. J. Nandhakumar,

doi:10.5281/zenodo.15957897

Research Paper | Open Access
Volume 03 | Issue 07 | Article Id IJPS/250307140

Impact Of Pharmacovigilance in Polycystic Ovary Syndrome and Identification of Its Risk Factors: In Ernakulam District [Four Regions: Perumbavoor, Cherukunnam, Odakkali, Nellikuzhi]
Alphonsa Mathew * Aleena Jose Anuja S. Babu Sampoornna S. Sreekutty S. Dr. J. Nandhakumar
Indira Gandhi Institute of Pharmaceutical Sciences, Perumbavoor, Ernakulam, Kerala.

Abstract

Polycystic ovary syndrome (PCOS) is one of the most common endocrine disorders occurring in women of reproductive age, presented by a combination of reproductive and metabolic abnormalities that arise from hormonal dysregulation. Pharmacovigilance is essential in monitoring the safety and efficacy of drugs for treatment of PCOS, emphasizing comprehensive monitoring of both early detection of ADRS and associated limiting factors with ADRS. The prospective cross-sectional study was conducted to evaluate the effectiveness of pharmacovigilance in the management of PCOS and to determine the possible risk factors for PCOS in women of Ernakulam District. Participants were belonging to age group 16-45 years. Data were statistically analyzed using the software IBM SPSS version 20.0, and the categorical variables were reported as frequencies and percentages. Chi-square tests were employed to validate the association between the use of a medication and ADRs. Results were observed that various risk factors are associated with the development of PCOS. The results also depicts that proper pharmacovigilance methods is essential to ensure the safety of drugs while prescribing drugs for treatment of PCOS.

Keywords

Polycystic Ovary Syndrome, Risk Factors, Adverse Drug Reactions

Introduction

Polycystic ovary syndrome was originally identified by Stein and Leventhal in 1935 as a syndrome characterized by amenorrhea, hirsutism and obesity related with enlarged polycystic ovaries. This endocrine disorder is most prevalent in women of reproductive age ^[1]. The most widely accepted diagnostic criteria for PCOS is Rotterdam Consensus (2003) which requires the presence of at least two of the following characteristics which are clinical and/or biochemical hyperandrogenism, oligo ovulation or anovulation and polycystic ovaries on ultrasound, with elimination of secondary causes of increased androgen level. While the etiology of PCOS is unknown, it is likely to be complex, the two key hormonal abnormalities that underpin PCOS are Insulin Resistance (IR) and hyperandrogenism along with the contribution of obesity, genetic inheritance, lifestyle and environment for the development of the disease. Ovarian dysfunction is the most common characteristic of PCOS driven by hyperandrogenism resulting in chronic oligo ovulation or anovulation and menstrual irregularities. Dermatological issues such as hirsutism, acne and male pattern alopecia is also caused due to increased androgen level in the body ^[2]. PCOS has been found to affect 28 percent obese and 5 percent lean women. The exact pathophysiology of PCOS is complicated and is unclear, the underlying hormonal imbalance caused by combination of increased androgens and insulin is the basis for developing PCOS. Among the genetic and environmental contributors to hormonal disturbances it also includes other factors such as plumpness, ovarian insufficiency, and hypothalamic pituitary disorders^[3]. According to studies, students have less knowledge about PCOS and its symptoms and signs, and that lifestyle preferences will make a person more susceptible to PCOS.Any delay in the diagnosis of PCOS may lead to metabolic disorders and congenital abnormalities associated with it^[4].The prevalence of PCOS was six percent in women from rural and urban area of Chennai which was diagnosed by the Rotterdam criteria. The estimated prevalence of PCOS in International studies reports range from 4-10 percent.It is challenging to reach a definite conclusion because the prevalence of PCOS must be higher or lower based on the criteria employed in these studies, which may be the clear reason for the discrepancies in prevalence rates among the Indian studies. In India, the prevalence of PCOS range from “3.7-22.5 percent” ^[5].

Review of Literature:

According to a cross-sectional clinical study conducted by Mohammad Abid Keen, Iffat Hassan Shah, Gousia Sheikh to study the incidence and prevalence of various cutaneous manifestations in patients with Polycystic Ovary Syndrome and to correlate these skin manifestations with hormonal changes which was carried out at a Dermatology Centre(2017).The study showed “the prevalence of hirsutism(78%),acne(48%),femalepattern hair loss(31%),Acanthosisnigricans(30%),Seborrhoea(29%), striae (13%),acrochordons(9%)”.^[6] Budharam S, Veeramreddy S, et al. (2020) employed a survey of 805 participants in Sangareddy, India, ages 16 to 30, to determine the risk factors for polycystic ovarian syndrome (PCOS) and its effects on the quality of life of young women. The findings indicated that “26.9% of people aged 16–20 had PCOS symptoms, followed by 21–25 (36.4%) and 26–30 (31.2%). Across all age categories, the main symptoms were irregular menstruation (12–20% oligo ovulation), anovulation (6–7%), and hirsutism (8.8–12.5%)”. Sedentary lifestyle choices and obesity were important contributing causes. The study emphasized how crucial it is to treat symptoms and enhance quality of life through early diagnosis, lifestyle changes, and patient counselling.^[8] The review by Anadu Ndefo U, Eaton A et.al. (2013): Polycystic Ovary Syndrome is estimated to affect “5–10%” of women. Hyperandrogenism, irregular menstruation, and ovarian cysts were important symptoms. Genetic and environmental factors frequently contribute to the pathophysiology, which includes insulin resistance, obesity, and hormonal abnormalities in the hypothalamic-pituitary-ovarian axis. Infertility, metabolic diseases, and long-term concerns like diabetes and cardiovascular disease are all associated with PCOS, according to studies. Antiandrogens or oral contraceptives are used to treat hyper androgenic symptoms, pharmaceutical therapies such as metformin and clomiphene for ovulation induction, and lifestyle modifications like exercise and weight loss.^[9]The prevalence and treatment of menstruation abnormalities and polycystic ovarian syndrome (PCOS) are highlighted in the literature review by Fatima N., Perween S., et al. (2023), with particular attention to the potential risks of prescription drugs. Hyperandrogenism, irregular menstruation, and ovarian dysfunction are some of symptoms of PCOS and it is linked to comorbid conditions including diabetes and obesity. In addition to pharmacological treatments like clomiphene citrate, oral contraceptives, and antidiabetic medications, management options often involve non-pharmacological measures including lifestyle modifications. In order to improve patient outcomes, the study emphasizes the significance of pharmacovigilance to track adverse medication reactions and customized treatment techniques.^[10]“A Consensus Statement on the Use of Oral Contraceptive Pills in Polycystic Ovary Syndrome Women in India” by Duru Shah, Madhuri Patil (2018): Regarding the application of OCP in PCOS-affected women, this consensus statement offers suggestions or guidelines for Indian practitioners. OCPs inhibit the production of androgens, decrease luteinizing hormone, and increase SHBG, which binds to androgens. The indications, contraindications, and issues concerning its short term, intermediate and long-term use were also discussed.^[11]Ruiqin Zhang and Jing Zeng conducted an observational and prospective study on the treatment of PCOS patients (2020), evaluating the safety and efficacy of drospirenone/ethinylestradiol tablets: BMI and waist-to-hip ratio considerably dropped during therapy compared to baseline. Following treatment, sex-hormones like testosterone, luteinizing hormone, and free androgen index were decreased significantly (p < 0.001).More follicular stimulating hormone (FSH) was produced. Comparing plasma insulin, fasting, and two-hour blood glucose levels to baseline revealed no changes. Bilateral ovarian volume (left and right) was visibly reduced following therapy (p < 0.05) in comparison to baseline. Dizziness, headaches, gastrointestinal disorders, and breast swelling and pain were the most commonly reported discomforts.^[12]

Objectives:

1. To evaluate the impact of pharmacovigilance on the management and treatment outcomes of PCOS.

2. To identify potential drug-related problems and adverse reactions associated with PCOS treatment.

3. To identify the demographic, clinical, and lifestyle risk factors associated with PCOS.

4. To assess the awareness and knowledge of PCOS among women in Ernakulam district.

METHODOLOGY:

Study site

The questionnaire were collected from community of Ernakulam district (Odakkali, Perumbavoor, Nellikuzhy, Cherukunnam)

Study design

Prospective cross-sectional research design

Sample size

We had collected 529 questionnaires of PCOS from the population, out of which 111 patients were diagnosed with PCOS.

Study period

We had conducted the study for a period of 4 months November 2024-February 2025.

Study criteria

Inclusion criteria

Age group 15-45, women residing in urban and rural area of Ernakulam district.

Women with PCOS diagnosed

Exclusion criteria

Women who are not willing to participate in the study
Women with endometrial cancer
Women with breast cancer
Menopausal women

Source of Data

Participant data that are relevant to the study is obtained from the following sources

Patient data collection proforma.
Informed consent form
Patient information leaflet

Method of data collection

This cross sectional study was carried out after getting the permission from Institutional Head, IGIPS, Perumbavoor and approval from Institutional Ethical Committee. Survey was conducted in girls or women of reproductive age group (16-45years) in the urban and rural area of Ernakulam District. A specially designed questionnaire has been used for data collection which included participant’s demographics, age of menarche and menopause, family history, menstrual history, lifestyle practices, treatment and management, emotional and social factors, common ADR that have occurred in patients taking medications.

Statistical method

All the data were collected from the participants after obtaining their consent. Statistical analysis was done using IBM SPSS version 20.0 software. Categorical variables were expressed as frequency and percentage. Continuous variable age was presented by mean±SD. Chi-Square test was used to test the statistical significance of the association between different medications with ADR.

RESULTS:

We have included 529 samples in our study. The mean age of the patients was 20.5±6.2 years and ranged from 16 years to 65 years. The mean age at menarche was 12.8±1.2 years. The mean BMI of subjects was 21.1±4.2.

Distribution of age class

Majority of the subjects were aged between 15-25 years, 26(439%) of subjects were aged between 25-35years, 13(2.5%) of subjects aged between 35-45 years, 9(1.7%) of cases were aged between 45-55 years and only 3(0.6%) were aged between 55-65 years.

Fig: 1.

Distribution of marital status

Among the total subjects, 56(10.6%) were married. 473(89.4%) were unmarried individuals.

Fig: 2.

Risk factors seen in participants

The graph below(fig.3) showing the distribution of various symptoms and experiences.239(45.2%) of subjects have Acne /Body tags,143(27%) have neck hump/ darkness around neck,112(21.2%) of cases have hair thinning/male pattern hair,216(40.8%) of subjects have irregular periods,439(83%) have premenstrual symptoms, 70(13.2%) of subjects have high flow of bleeding, 403(76.2%) have moderate and 56(10.6%) of cases have low flow of bleeding,101(19%) subjects were experiencing sudden weight gain,15(2.8%) were obese and 324(61.2%) of subjects have stress.

Fig: 3. Risk factors

Distribution of different premenstrual symptoms.

The graph shows the distribution of different premenstrual symptoms observed in the subjects. Among the subjects with premenstrual symptoms, 120(27.3%) of subjects have breast tenderness, 94(21.4%) have blotting, 338(77%) have period cramps and 190(43.3%) have weakness.

Fig: 4

Table: 1.1 Junk food consumption of participants

Junk food	Frequency	Times	Frequency	Percent
No	47	-	-
Yes	482	Daily	24	5.0
		monthly	281	58.3
		Twice in a week	4	0.8
		Weekly	173	35.9

Among the 482 subjects consuming junk foods, 24(5%) consume junk food daily, 281(58.3%) monthly and 173(35.9%) weekly.

Diagnosis of PCOS in participants

Out of the total subjects, 111(21%) were diagnosed with PCOS.

Fig: 5

Table 1.2: Distribution of diagnosis and medication

Diagnosis

(PCOS)

Medication

Yes n (%)

No n (%)

Yes

52(78.6)

25(21.4)

Among the patients who have PCOS, 92(78.6%) patients were taking treatment

Distribution of comorbidities

Among the total subjects, 66(12.5%) of cases have various comorbidities. Among the total participants, 13(2.5%) have diabetes, 3(0.6%) have hyperlipidemia, 14(2.6%) have hypertension and 43(8.1%) have thyroid.

Fig:6

Distribution of Family history of PCOS in participants

Among the total subjects, 166(31.4%) have family history of comorbidities and 18(3.4%) of cases have family history of PCOS.

Fig: 7

Table: 1.3: Emotional and social support in participants

Variables		Frequency	Percent
Mood symptoms	Yes	430	81.3
	Sometimes	1	0.2
	No	98	18.5
Sleep 6-8 hours daily basis	Yes	378	71.5
Sleep 6-8 hours daily basis	No	151	28.5

The above table showing the distribution of emotional and social support in participants. Among the total subjects, 430(81.3%) of subjects have experienced mood swings, 378(71.5%) have sleep of 6-8 hours daily basis.

Distribution of medications administered for PCOS

Out of total subjects, 52 (17.4%) of subjects were taken medication for PCOS/PCOD treatment. Among the 52 subjects, 18(34.6%) were taking nutritional supplements,19(36.65%) were taking hypoglycaemic medicines, 19(36.65%) were using oral contraceptives,3(5.8%) were taking anti-androgen medicines, 3(5.8%) were taking hematinics, 2(3.8%) were taking selective estrogen receptors modulators, 2(3.8%) were taking non-steroidal competitive aromatase inhibitors and 5(9.6%) were taking both hypoglycaemic medications and nutritional supplements.

Fig: 8.

Adverse drug reaction of medication in participants

Among the 52 subjects taking treatment for PCOS, 47 (90.4%) have adverse drug reactions on medicines.

Fig: 9

Distribution of different medications with gastrointestinal problem

The above table showing distribution of different medications with gastrointestinal problem in participants. There was statistically significant association between medications with gastrointestinal problem.

Fig: 10. Medications with Gastrointestinal problem in participants

Distribution of different medications with Hormonal problem

The figure below showing distribution of different medications with hormonal problem. There was statistically significant association between medications with hormonal problem.

Fig: 11. Medications with Hormonal problem

Distribution of different medications with Dermatological issues

The graph shows distribution of different medications with dermatological problem. There was statistically significant association between nutritional supplements with dermatological problem. The chance of dermatological problem was decrease by taking nutritional supplements. Other medications showed statistically no significant association.

Fig:12. Medications with Dermatological issues

Feedback Response

Distribution of patients feeling free to consult gynecologist

Among the total subjects, 230(43.5%) of cases were feeling free to consult gynaecologists.

Fig.13.

Distribution of perception of curability

Among the total subjects, 334(63.1%) have understood about PCOS that it is a curable disease.

Fig: 14.

Among the total 529 subjects, we have given questionnaire which includes more details of medications and its adverse drug reactions to 52 individuals. We have given feedback form to 222 individuals.

Distribution of individuals following healthy life style after awareness programme

192(86.5%) of subjects were following healthy lifestyle after awareness programme.

Fig: 15.

All the 222 individuals were felt the information provided was useful.

DISCUSSION:

All the components included in the statistical analysis are associated with PCOS. Hence it becomes relevant to assess each of the statistically distributed components that lead to PCOS.

Demographic Distribution

Age Distribution: A total of 529 samples were included in the study from Ernakulam district (Odakkali, Perumbavoor, Nellikuzhi, Cherukunnam).The mean age of the patients was 20.5±62 years and ranged from 16 to 65 years. The mean age of menarche was 12.8±1.2years. Majority of the subjects studied were found to be having age between 15-25years. The high prevalence of Polycystic Ovary syndrome was observed in the age group having 15-25 years.

Marital Status Distribution: Out of the total 529 subjects, 473 were unmarried and 56 were found married. The marital status is a key factor considered while prescribing medications for treatment of PCOS.

Risk factors distribution

The variables of risk factors associated with PCOS were acne, acanthosis, hair thinning, oligo menorrhea, menorrhagia, obesity, PMS, stress and sudden weight gain. Acne/Body tags were indicated in 239 subjects among total sample. Acanthosis was found in 14 subjects, hair thinning in 112 subjects, oligomenorrhea in 216, menorrhagia in 70 participants. 439 of total sample were having pre-menstrual symptoms like blotting, breast tenderness, period cramps and weakness.324 were having stress. Obesity and sudden weight gain was observed in 15 and 101 subjects respectively.

Lifestyle and diet distribution

Following a healthy lifestyle reduces the chance of developing PCOS. It was found that out of the total subjects 113 were following a balanced diet and 204 subjects are involved in physical activities. 482 subjects were consuming junk foods on daily, weekly or monthly basis.

Diagnosis of PCOS of patients

The main strategy of the study conducted in 529 subjects is for analyzing the PCOS prevalence and the occurrence of any adverse drug reactions while administering the drugs used for treatment of PCOS.We found that 111 out of 529 samples were diagnosed with PCOS. Out of these 111 subjects, 52 (77.5%) were taking medications for the treatment.

Distribution of comorbidities

It was found that some comorbidities are leading to the development of PCOS other than the risk factors that are previously mentioned. It was observed that 12.5% were having these comorbidities such as diabetes (2.5%), hyperlipidemia (0.65%), hypertension (2.6%) and thyroid (8.1%).

Distribution of family history of PCOS in participants

Subjects having family history of PCOS are more prone to develop PCOS. Among the total subjects, 18 (3.4%) of cases have family history of PCOS.

Emotional support in participants

In this data provides insight into the emotional and social wellbeing of the participants, particularly focusing on mood symptoms and sleep patterns .Among the total subjects 430 (81.3%) of subjects were experienced mood swings and 378(71.5% ) have normal sleep upto 6-8 hours on daily basis .Addressing both emotional support and sleep quality could be essential in improving overall wellbeing .

Distribution of medications administered for PCOS

In this total subjects, 52 (17.4%) of subjects were taking medication for treating PCOS. Among the 52 subjects, 18(34.6%) were taking nutritional supplements, 19(36.65%) were taking hypoglycaemic medicines, 19(36.65%) were using oral contraceptives, 3(5.8%) were taking anti-androgen medicines, 3(5.8%) were taking hematinics, 2(3.8%) were taking selective estrogen receptors modulators, 2(3.8%) were taking non-steroidal competitive aromatase inhibitors and 5(9.6%) were taking both hypoglycaemic medications and nutritional supplements. The majority of PCOS patient in the study were treated with hypoglycaemic agents. The use of nutrition supplement suggest an effort to manage PCOS holistically.

Adverse drug reaction of medication in participants

The data on Adverse Drug Reactions (ADR) among participants taking medication for PCOS show that out of 52 subjects, 47 (90.4%) have adverse drug reactions on medicine. A very high proportion (90.4%) of participants reported experiencing side effects from their medications.

Distribution of different medications with gastrointestinal problem

The data presents the distribution of gastrointestinal (GI) problems associated with different medications used for PCOS treatment, along with their statistical significance. 50% of the patients taking nutritional supplements experienced GI problems. The p-value is 0.226. Hypoglycemic medication 54.5% of users reported GI issues. The p-value 0.523 was not statistically significant. 66.7% of users of oral contraceptives had GI issues, compared to 54.8% of non-users. The p-value 0.394 was not statistically significant. 50% of users of anti-androgen medication had GI issues. 66.7% of hematinic users had GI issues. Selective estrogen receptor modulators 100% (1user) had GI issues. Non -steroidal competitive aromatase inhibitors 0% of users had GI issue. 55.6% of users taking progestin therapy had GI issues, compared to 60.5% of non-users. P-value was 0.999.

Distribution of different medications with hormonal problem

The data examines the relationship between different medications used for PCOS treatment and the presence of hormonal problems in participants, along with the statistical significance (p-values). Nutritional Supplements, 72.7% of users reported hormonal problems.P-value is 0.355 (not statistically significant). Hypoglycaemic medications 86.4% of users had hormonal issues. P-value is 0.256 (not statistically significant) .Oral Contraceptives (OCPs), 90.5% of users reported hormonal issues, compared to 71% of non-users.P-value is 0.091 (Close to significance but not quite).

Anti-androgen medications, 100% of users reported hormonal problems. No p-value provided, likely due to the small sample size (only 2 users).Hematinic 33.3% of users had hormonal problems, much lower than 81.6% of non-users. Selective Estrogen Receptor Modulators (SERMs) 100% of users (only 1 person) had hormonal problems.Non-Steroidal Competitive Aromatase Inhibitors, 50% of users had hormonal problems. Progestin therapy, 100% of users reported hormonal problems, compared to 74.4% of non-users.P-value is 0.177 (not statistically significant). Most participants reported hormonal issues, regardless of medication use. Oral contraceptives (90.5%) and anti-androgens (100%) had higher hormonal issue rates, suggesting they may be influencing hormone-related side effects. Progestin (100%) also showed a high rate of hormonal issues, but due to the small sample size, the statistical significance is unclear. Hematinic users had fewer hormonal problems. Oral contraceptives, anti-androgens, and progestins might be causing hormonal fluctuations as part of their mechanism of action.

Medications with dermatological issues

The data examines the relationship between different medications used for PCOS and the occurrence of dermatological issues such as acne, excessive hair growth, or skin pigmentation, along with their statistical significance (p-values).Nutritional supplements, 45.5% of users had dermatological issues.P-value was found to be 0.041 (statistically significant). Hypoglycaemic medications (e.g., Metformin), 63.6% of users had dermatological issues .P-value was found to be 0.790 (Not statistically significant). Oral Contraceptives (OCPs), 61.9% of users had dermatological issues when compared to 61.3% of non-users. P-value was found to be 0.964 (not significant) .Anti-androgen medications are not causing any dermatological side effects in users.

Distribution of patients feeling free to consult gynecologist

Most of the people are not willing to consult gynecologist due to social stigma and myths. The data shows that 230 participants (43.5%) felt free to consult a gynecologist.299 participants (56.5%) did not feel comfortable in consulting a gynecologist.

Distribution of curability

Conclusion on perception of PCOS curability, 334 participants (63.1%) believe that PCOS is a curable disorder.195 participants (36.9%) believe that PCOS is not curable. Majority (63.1%) of participants misunderstand PCOS as a curable condition, while 36.9% correctly understand that it is a manageable but not completely curable condition. PCOS is a chronic condition that can be managed effectively with lifestyle changes, medications, and medical interventions, but it does not have a permanent cure. This data suggests a knowledge gap regarding PCOS as a lifelong condition requiring ongoing management rather than a one-time cure.

Distribution of individuals following healthy life style after awareness programme

Conclusion on healthy lifestyle adoption after awareness programme.192 participants (86.5%) adopted a healthy lifestyle after attending the awareness program.30 participants (13.5%) did not make any lifestyle changes. Awareness programs play a crucial role in influencing positive behaviour change for PCOS management. Follow-up support, counselling, and structured lifestyle plans may help the remaining 13.5% adopt healthier habits.

CONCLUSION:

Polycystic Ovary Syndrome (PCOS) is an endocrine disorder which is most prevalent in women in their reproductive age. This study sought to raise awareness and knowledge about Polycystic Ovary Syndrome (PCOS) among women in Ernakulam, as well as determine treatment outcomes, risk factors of PCOS and adverse drug reactions (ADRs) associated with PCOS drugs. It is widely known that lifestyle factors play an important role in the development of PCOS, necessitating lifestyle interventions. This study aims to comprehensively explore the impact of pharmacovigilance, identification of its risk factors, lifestyle modifications on the progression of PCOS. In our study, we found that most of the study populations were not having a healthy lifestyle. According to the data, 414 out of 529 participants do not maintain a balanced diet, 325 do not engage in any physical exercise, and the majority of them consume junk food as part of their daily routines. Approximately 84% of people started a healthy lifestyle after taking awareness sessions. Participants' varied risk factors included acne/body tags (27%), neck hump/darkness around the neck (21.2%), hair thinning/male pattern hair growth (40.8%), irregular periods (83%), abrupt weight increase (2.8%), and other conditions that we discovered during our study. Elevated androgen levels in individuals with PCOS can lead to visible symptoms such as acne, body tags, male-pattern hair growth (hirsutism) and hair thinning. A striking of participants reported irregular menstrual cycles, which is a hallmark of PCOS. These irregularities are linked to chronic anovulation, which can lead to infertility if left untreated. Additionally, the psychological burden of visible symptoms like hirsutism and weight changes can perpetuate emotional distress, creating a vicious cycle. Identifying the risk factors for PCOS patients offers the likelihood of gradually preventing some of the long-term complications associated with this PCOS. Some comorbidities like thyroid, hypertension, hyperlipidemia, and diabetes were also associated with PCOS. According to our research, 66% of people have comorbidities, which increases their long-term risk of developing metabolic disorders, hormone-dependent malignancies, cardiovascular disease, and type 2 diabetes. Further research is necessary to improve diagnostic processes which aims in selecting specific treatment, individualized therapy and lifestyle modifications. Common adverse effects that can also impact a person's way of life include gastrointestinal problems, skin problems, and hormonal problems. The study makes it abundantly evident that every drug used to treat PCOS has a number of adverse effects, such as hirsutism or infertility, menstrual irregularities, blotting, acne and severe bleeding during the menstrual cycle. We found that using specific medications that is used in PCOS treatment increases the risk of hormonal problems, dermatological problems and gastrointestinal problems. These were statistically significant association between medications with adverse effects. The development of these adverse drug reactions emphasizes on more pharmacovigilance studies for the medications administered for PCOS treatment.

Limitations:

Limited data on long term safety.
Need for more studies on medication use in special population.
Limited duration of study which was only for 4 months.
Feedback form was able to collect only from 222 participants due to unavailability of participants and limitation of time.
Limited data collected from participants who are under treatment of PCOS due to insufficiency of time.

Future Directions:

There is a need for more studies on the long-term health outcomes of PCOS, such as the risk of cardiovascular disease, type 2 diabetes, and hormone-dependent cancers and in the development of metabolic disorders.
More research is required to determine how genetic and environmental factors lead to the development of PCOS, as well as how endocrine disruptors and lifestyle factors play a part.
Further research is required to understand how PCOS naturally develops across a woman's life, both during her reproductive years and after menopause.

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