Department of Medicine, Medical College Kolkata, Kolkata, India
*Corresponding Author e-mail: docr89@gmail.com

طفح دوائي ثابت منتشر بسبب دواء ديكلوفيناك
ريدراجيت ب�ل, ق�اتام ليهريي, تامني ج�تي �ضاو, ك�نال هالدار, راجي�ص باندي, عا�ضم �ضاها

Extensive Fixed Drug Eruption Due to Diclofenac
*Rudrajit Paul, Gautam Lahiri, Tanmay J. Sau, Kunal Haldar, Rajesh Pandey, Asim Saha

A 46-year-old male construction workerwas admitted to a clinic in Kolkata, India, in 2016 with a sudden-onset black rash 
appearing in patches all over his body. He had sprained 
his left foot two days previously for which he was 
prescribed oral diclofenac tablets at a dose of 50 mg 
three times a day. He had taken three doses of the drug 
before noticing the skin lesions; however, he continued 
taking the drug due to the pain and presented to 
the clinic on the third day when the lesions became 
extensive. He was not currently taking any other drugs 
and had no history of similar skin lesions. 

On examination, the patient was noted to have 
darkly pigmented patches on his trunk and both the 
upper and lower limbs [Figure 1]. The patches covered 
more than 50% of his body surface and were non-
pruritic and non-tender, with sharply demarcated 
margins and surrounding erythema. No evidence of 
mucosal lesions or hair or nail changes was seen. The 
patient was treated with local emollients and a steroid 
cream. A skin biopsy revealed interface dermatitis with 
vacuolar changes. The patient was diagnosed with a 
fixed drug eruption (FDE) caused by the diclofenac. 
After 10 days, the patches became scaly and started to 
desquamate [Figure 2]. 

Figure 1: Extensive hyperpigmented patches on the (A) trunk, (B) arms and (C) legs of a 46-year-old man after taking 
50 mg of diclofenac three times a day for three days.

Sultan Qaboos University Med J, February 2017, Vol. 17, Iss. 1, pp. e121–122, Epub. 30 Mar 17
Submitted 18 Sep 16
Revision Req. 26 Oct 16; Revision Recd. 28 Oct 16
Accepted 10 Nov 16 doi: 10.18295/squmj.2016.17.01.024

INTERESTINg MEDICAL IMAgE 



Extensive Fixed Drug Eruption Due to Diclofenac

e122 | SQU Medical Journal, February 2017, Volume 17, Issue 1

of similar lesions at the same site. Sometimes, FDEs 
may not occur on initial use of the drug and manifest 
only after a certain dose is attained.1 Nonetheless, 
drug rechallenge is not always ethically possible; a 
skin biopsy is therefore sufficient to diagnose the 
condition at first onset.2 With diclofenac, various 
cutaneous reactions can occur after oral or parenteral 
administration, including anaphylactic reactions, 
urticaria, exanthema and FDEs.6

While there is no definitive histology pattern 
for FDEs, severe vacuolar interface dermatitis is 
suggestive of the condition, along with other pheno-
typic features, such as confluent epidermal necrosis 
and extension of the infiltrate into the lower half 
of the dermis.2,5 The use of the Naranjo algorithm, 
particularly the sections regarding previous exposure 
and readministration, is not always applicable in 
these cases on ethical grounds.7 However, a thorough 
history-taking, specifically with regards to recent 
exposure to certain drugs, can help to confirm the 
diagnosis. In addition, the new World Health 
Organization-Uppsala Monitoring Centre scale may 
help to determine aetiology in such cases.8 Clinicians 
should be aware of rare cutaneous reactions to 
common drugs often used in clinical practice, such as 
that observed in the current case with diclofenac.

References
1. Augustine M, Sharma P, Stephen J, Jayaseelan E. Fixed drug 

eruption and generalised erythema following etoricoxib. Indian 
J Dermatol Venereol Leprol 2006; 72:307−9. doi: 10.4103/0378-
6323.26732.

2. Jain SP, Jain PA. Bullous fixed drug eruption to ciprofloxacin: 
A case report. J Clin Diagn Res 2013; 7:744–5. doi: 10.7860/
JCDR/2013/4757.2901.

3. Lin TK, Hsu MM, Lee JY. Clinical resemblance of widespread 
bullous fixed drug eruption to Stevens-Johnson syndrome or 
toxic epidermal necrolysis: Report of two cases. J Formos Med 
Assoc 2002; 101:572–6.

4. Hsiao CJ, Lee JY, Wong TW, Sheu HM. Extensive fixed drug 
eruption due to lamotrigine. Br J Dermatol 2001; 144:1289–91. 
doi: 10.1046/j.1365-2133.2001.04266.x.

5. Fathallah N, Ben Salem C, Slim R, Boussofara L, Ghariani N, 
Bouraoui K. Acetaminophen-induced cellulitis-like fixed drug 
eruption. Indian J Dermatol 2011; 56:206–8. doi: 10.4103/0019-
5154.80419.

6. Deepalatha C, Prasad RV, Chandra S, Mohan PM, Lakshmi V. 
Diclofenac-induced urticaria in paediatric patient. Asian J 
Pharm Clin Res 2013; 6:1–2.

7. Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, 
et al. A method for estimating the probability of adverse drug 
reactions. Clin Pharmacol Ther 1981; 30:239–45. doi: 10.1038/
clpt.1981.154.

8. Gupta LK, Beniwal R, Khare AK, Mittal A, Mehta S, Balai M. 
Non-pigmenting fixed drug eruption due to fluoroquinolones. 
Indian J Dermatol Venereol Leprol 2017; 83:108–12. 
doi: 10.4103/0378-6323.190890.

Comment

FDEs are drug-induced lesions which may appear 
as patches, vesicles or bullae.1 Hyperpigmentation 
is usually noted at the site of the lesions and recurs 
at the same sites with subsequent exposure to the 
drug.1 Usually, the lesions are limited to a small area 
of the skin or mucosa.2 However, extensive FDEs have 
been reported with nonsteroidal anti-inflammatory 
drugs (NSAIDs), lamotrigine and antibiotics such 
as vancomycin.3,4 Lin et al. reported two patients 
with NSAID-induced extensive bullous eruptions 
mimicking Steven-Johnson syndrome.3 In another 
case, an extensive paracetamol-induced eruption was 
initially suspected to be cellulitis; the patient was 
treated with antibiotics before new lesions appeared 
and a skin biopsy led to a FDE diagnosis.5 Extensive 
hyperpigmented dermal patches can sometimes be 
confused with photoallergic/toxic reactions, café-au-
lait macules or Addison’s disease.4 

The mainstay of treatment for FDEs is with- 
drawal of the drug.1,5 Although local steroids and/or 
emollients may be used, systemic therapy is usually 
not needed.5 In general, FDEs are easy to diagnose 
if the presenting features are typical. However, 
atypical lesions—such as non-pigmenting FDEs or 
psoriasiform lesions—may also occur.2 As FDEs recur 
at the same site on subsequent contact with the drug, 
a diagnosis can be made if there is a previous history 

 
Figure 2: Scaling and desquamation of hyperpigmented 
patches caused by a diclofenac-induced fixed drug 
eruption on the (A) arms and (B) legs of a 46-year-old 
man after 10 days of treatment with local emollients and 
a steroid cream.

https://doi.org/10.4103/0378-6323.26732
https://doi.org/10.4103/0378-6323.26732
https://doi.org/10.7860/JCDR/2013/4757.2901
https://doi.org/10.7860/JCDR/2013/4757.2901
https://doi.org/10.1046/j.1365-2133.2001.04266.x
https://doi.org/10.4103/0019-5154.80419
https://doi.org/10.4103/0019-5154.80419
https://doi.org/10.1038/clpt.1981.154
https://doi.org/10.1038/clpt.1981.154
https://doi.org/10.4103/0378-6323.190890