Int J Curr Pharm Res, Vol 10, Issue 6, 13-15Original Article



1Department of Pharmacology, Santhiram Medical College and General Hospital, Nandyal, 2Department of Pharmacology, Prathima Medical College, Karimnagar, 3Patient Safety Pharmaco Vigilance Technical Associate, Bhaskar General Hospital

Received: 11 Jul 2018, Revised and Accepted: 07 Sep 2018


Objective: To evaluate prevalence of cutaneous adverse reactions in young adult age group using ADR notification form. To create awareness in hospitals and health sectors, to establish drug safety monitoring units for mother and child care.

Methods: Individual case safety reports of 46 patients from various hospitals were analyzed using CDSCO forms. To tabulate data on drugs, doses, systems, ADRs and factors for causation of cutaneous ADRs.

Results: Females are more prone compared to males due to pregnancy at young age with increased use of Iron combinations, antibiotics and antiepileptic’s in young adult age groups (20-30yrs) among cutaneous ADRs.

Conclusion: We conclude the need for establishment of drug safety units with generic units for maternity sections and use of drugs in pre and post natal period, as pregnancy and adult age are risk factors for cutaneous adverse drug reactions. Every hospital structure needs special caution on drug lots of iron preparations, antibiotics, analgesics, antiepileptic’s to be used in Obstetrics and Gynecology departments.

Keywords: Cutaneous ADRs, Antibiotics, Iron preparations, Drug safety units


Cutaneous ADRs are predominant with Non-Steroidal Anti-inflammatory drugs, Anti-epileptics and Antimicrobials [1]. Known causative factors include hypersensitivity, polypharmacy and decreases of generic brands [2]. The present study is to create awareness among health care professionals to promote generic drugs and responsible use of drugs towards vulnerable patient’swith age group of 20-30 where in pregnancy is very common.


The present study is carried out taking cutaneous ADRs from various hospitals across Telangana and Andhra Pradesh states. Collection of Individual case safety report forms along analysis of causative factors like, age, gender, drugs, doseregimen and studywas carried out for 3 mo on 46 patients of cutaneous Adverse Drug Reactions. Causality assessment done, using WHO-UMC scale and severity assessment done using Hartwig Seigel scale. Dataanalysed and results tabulated.


Total patients of 46 were include in the study of which 27(58.69%) females and 19 (41.30%) males. The present study shows that Ferric Carboxy Maltose, parental iron preparation and antibiotics like Cephalosporins (ceftriaxone) and Tinidazole used for pregnancy induced anemia. Antibiotics used for pre and post-operative sections and anti-epileptics (Phenytoin) are the main drugs that contribute to increase incidence of cutaneous ADRs in group 20-30 y [3].

Fig. 1: Percentage distribution of causality assessment

Table 1: Gender wise distribution of patients

Gender No. of Patients Percentage (%)
Females 27 58.69
Males 19 41.30

Table 2: Distribution of types of drugs responsible for ADRs

Drugs No. of patients Percentage
Iron carboxy maltose(3)+Iron sucrose(6) 9 20
Antibiotcs 25 55
NSAIDs 2 4.4
Antiemetics 2 4.4
Multivitamins 4 9
Antiepileptics 3 7
Immunosuppressants 1 2

Fig. 2: Distribution of causality assessment of ADRs

Table 3: Usage of brand drug vs generic drugs

Drugs No. of patients Percentage (%)
Brand 29 62
Generic 8 17

Fig. 3: Usage of brand drug vs generic drugs

Table 4: Causality assessment distribution among patients

Causality assessment No. of Patients Percentage (%)
Certain 01 2.17
Probable 43 93.4
Possible 02 4.34

Table 5: Drugs associated with systems involved in ADRs

Drugs Systems involved in ADRs Percentage (%)
Iron carboxy maltose+Iron sucrose Cutaneous 20
Antibiotcs () Cutaneous+GIT 55
NSAIDs Cutaneous 4.4
Antiemetics Cutaneous 4.4
Multivitamins Cutaneous 9
Antiepileptics Cutaneous 7
Immunosuppressants Extra pyramidal Symptoms 2

Fig. 4: Drug associated with systems involved in ASRs


This study shows 20% of patients suffer due to administration of parental iron preparation during pregnancy and 36% of patients suffer due to antibiotics used in prenatal and postnatal periods suggesting 56% of patients young adult age are females who have attained pregnancy indicating the need of art to establish maternal section in pharmacy section of hospitals wherein closed monitoring of drugs is needed, establishment of P drug concept by Obstetrics and Gynecology department and supply of generic drugs is maintained to restrict cutaneous ADRs [4]. Other drugs which cause cutaneous ADRs include antibiotics used for diarrheal infections, tuberculosis, leprosy, pharyngitis suggesting improvement of hygienic conditions and use of prescribed drugs and to curb over the counter drugs. Use of NSAIDs, antiemetics, antiepileptics is minimal. The percentage of cutaneous ADRs caused by branded drugs (63%) is more compared to generic (17%) drugs [5]. Hence generic pharmacies are recommended to decrease the occurrence of cutaneous ADRs.


We conclude that cutaneous ADRs are more predominant in females than males as drugs used in pregnancy safe and are responsible for cutaneous ADRs hence need of the hour is to maintain separate section for drugs used in pregnancy with generic drugs in every hospital and caution to be taken for drug lots causing cutaneous ADRs [6]. Rise of every clinician to develop “P” drug concept in order to use drugs in pregnant women.


All the author have contributed equally


Declared none


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About this article




Cutaneous ADRs, Antibiotics, Iron preparations, Drug safety units





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International Journal of Current Pharmaceutical Research
Vol 10, Issue 6 (Nov-Dec), 2018 Page: 13-15

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Authors & Affiliations

C. Nagaratnam
Department of Pharmacology, Santhiram Medical College and General Hospital, Nandyal,

B. Deepika
Department of Pharmacology, Prathima Medical College, Karimnagar,

C. Deepalatha
Patient Safety Pharmaco Vigilance Technical Associate, Bhaskar General Hospital


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