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Case report

Fixed drug eruption due to co-trimoxazole: a case report

B. C. Dwari , S. Bajracharya, S. Gupta, P. Mishra, S. Palaian, K. Alam, S. Prabhu, M. Prabhu

Department of Dermatology, Department of Pharmacology, Department of Hospital and Clinical Pharmacy, Manipal
Teaching Hospital / Manipal College of Medical Sciences, Pokhara, Nepal and Department of Dermatology, Kasturba
Medical College, Manipal, Karnataka, India.
Correspondence to: Dr. Binayak Chandra Dwari MD, Lecturer, Manipal Teaching Hospital / Manipal College of Medical
Sciences, Pokhara, Nepal. Phone: +977 61 526416 Extn: 130/221

Background: Cotrimoxazole is a synergistic fixed dose combination of sulfamethoxazole and

trimethoprim used in treatment of several infections including urinary, respiratory, gastrointestinal
tract infections. Because of its wide spectrum and low cost it is one of the most preferred antimicrobial
in Nepal. Fixed drug eruptions (FDEs) are drug rashes which tend to occur at the same site in the
particular patient each time when an offending drug is administered. Co-trimoxazole is a drug commonly
implicated for causing FDEs.
Case report: We report a case of FDE due to co-trimoxazole occurred in a patient for whom it was
prescribed by a local practitioner without taking adequate medication history. We also carried out
the causality, severity, preventability and predictability as well as the economic impact of the
associated adverse drug reaction (ADR). The report suggests that before prescribing any drug,
clinicians should take appropriate medication history and upon occurrence of any ADR the patient
should be counseled and instructed to communicate with the clinicians wherever they attend for the
next time.
Keywords: Causality assessment, Co-trimoxazole, Fixed drug eruption, Naranjo algorithm.

Introduction Case report

Cotrimoxazole is a synergistic fixed dose combination of A 59 year female, patient, a known case of asthma on oral
sulfamethoxazole and trimethoprim at a 5:1 ratio. 1 They have theophylline and prednisolone regularly, presented to the
been indicated for urinary, respiratory and gastrointestinal dermatology Out Patient Department (OPD) on 16-02-06 with
tract infections, otitis media, gonorrhea, cholera and several complaints of some pruritic red colored lesions over the
other infections.2 Antibacterial activity of cotrimoxazole is due both legs for 2 days followed by vesiculation and
to combined effects of inhibition of PABA into folic acid and pigmentation over the lesions (Fig 1). She gave history of
prevention of the reduction of dihydrofolate to tetrahydrofolate taking Tab. Cotrimoxazole for 2 days advised by the local
which is essential for synthesis of thymidine.3 Its major side practitioner. The patient also gave past history of two similar
effects are nausea, diarrhea, headache, vomiting, liver damage episodes (pruritus followed by erythematous plaque and
etc. 4 It is also known to cause fixed drug eruption commonly . violet plaques) over the same sites 14 and 19 month back
We hereby report a case of Fixed Drug Eruption (FDE) caused after taking some medicines as advised by the local
by co-trimoxazole which can be attributed to the lack of practitioner (details of medication not available, but based
counseling of the patient. on the history it is assumed to be co-trimoxazole).

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B. C. Dwari , S. Bajracharya, S. Gupta et. al

tend to occur at the same site in the particular patient each

time the drug administered. 8 The usual morphology is
intensively pruritic bright red macules and papules,
symmetric on trunk and extremities; may became confluent.9
Common causes of fixed drug eruptions are barbiturates,
phenolphthalein, tetracycline, griseofulvin, phenytoin,
salicylate, sulphonamide etc.10 The mechanism of most drug
induced eruptions are unknown. However, it may be due to
allergic reaction, other reaction caused by accumulation of
dugs, pharmacological action of drugs or interaction with
genetic factors. 11
Many times it becomes difficult to attribute a particular ADR
to a drug. This state of ambiguity can be overcome by
Fig. 1: Pruritic red colored lesions over the both legs carrying out the causality assessment. Causality
followed by vesiculation and pigmentation over the lesions assessment of ADRs is the structured and standardized
(The lesions are hindered with gentian violet speeded over) assessment of individual patients/ case reports of the
likelihood of a causal relationship between suspected drugs
On clinical examination, well-defined, erythematous, plaques
and adverse medical events. In the early 1980s, in an attempt
over the surface of thighs along with hyperpigmentated,
to reduce ambiguity in the evaluation of adverse drug
plaques with vesiculation over both legs, and crusted
reactions, different standardized causality assessment
plaques over both lips were seen. Genitalia and oral cavity
scales were introduced at pharmacovigilance centers in
were normal. A provisional diagnosis of probable FDE due
many centers in many countries around the world.12 Asimple
to co-trimoxazole was made and patient was admitted under
method to assess the causality of ADRs in a variety of
dermatology department. All medications were stopped.
clinical situations was developed by Naranjo et al in 1981.
Complete blood count (CBC), erythrocyte sedimentation
In this scale, the probability that the adverse event was
rate (ESR), bleeding time, clotting time were sent and were
related to drug therapy was classified as definite, probable,
found to be with in normal limits. The patient was detected
and possible or doubtful. 5 In our case the causality was
to be diabetic with slight increase in the blood glucose
found to be ‘Definite’ suggesting that the development of
(Fasting 112 Mg/dl and post prandial 250 Mg /dl) levels.
FDE is definitely attributable to co-trimoxazole.
Patient was then started on intravenous steroids
The term severity is often used to describe the intensity of
(dexamethasone), topical antibiotics, oral analgesic and
a medical event, as in grading ‘mild’, ‘moderate’ and
antihistamines. Patient improved with no new lesions during
‘severe’. Severity assessment categorizes the ADRs as mild,
admission and was finally discharged after seven days on
moderate, or severe based on the steps taken for the
tapering dose of steroids. Theophylline for asthma was also
management of the ADRs. 14 The United States Food and
restarted. Patient was then followed up after 2 weeks in
Drug Administration (US FDA) classifies an ADR as serious
dermatology OPD. Previous lesions were healed and there
when it results in death, life- threatening causes, or prolongs
were no new lesions. The patient was also educated
hospitalization, causes a significant persistent disability,
regarding the ADR and counseled regarding the strategies
results in a congenital anomaly, or requires intervention to
to prevent similar problems in the future.
prevent permanent damage.13 Hartwig et al categorized ADRs
We carried out the causality, severity and preventability into seven levels as per their severity. Level 1 and 2 fall
and predictability assessments for this Adverse Drug under mild category, level 3 and 4 under moderate and level
Reaction (ADR) as per Naranjo algorithm 5, Modified Hartwig 5, 6 and 7 fall under category severe. 6 In our case the ADR
and Siegel Scale 6 and Modified Schumock and Thornton was found to be ‘moderately severe level 4 (b)’ suggesting
scale 7 respectively. It was found that ADR was ‘definitely’ that this ADR required hospitalization for its management.
attributable due to the co-trimoxazole and was found to be It is well reported in the literature that ADRs account for 5%
‘moderately severe level 4 (b)’. The ADR was also found to of all hospital admissions and causes death in 0.1% of
be ‘predictable’ and ‘definitely preventable’. medical and 0.01% of surgical cases. 14

Discussion Carrying out the predictability assessment can help the

clinician to predict and prevent the occurrence of similar
Fixed drug eruptions are characterized by the fact that they ADRs in the future. In our case the ADR was found to be

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Fixed drug eruption due to co-trimoxazole

predictable and definitely preventable. It is reported that Pokhara, Nepal for reviewing the initial manuscript and
the most common type of drug-induced disorder is dose- suggesting modifications.
dependent and predictable and occurs as a result of drug-
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