ORIGINAL ARTICLE

Oral mucosal fixed drug eruption: Characteristics and

differential diagnosis

Esen Ozkaya, MD
Istanbul, Turkey

Background: Little is known about the characteristic features of oral mucosal fixed drug eruption (FDE).

Objective: To present the clinical highlights and the differential diagnosis of oral mucosal FDE in a
relatively large group of patients from Turkey.

Methods: This was a methodological, retrospective, cross-sectional study of 61 patients with oral mucosal
FDE. The causative drug was established mainly by oral provocation test.

Results: The age range of 61 patients (38 females, 23 males) was 7 to 62 years. Naproxen and
cotrimoxazole were the main inducers. Fourteen patients (23%) had a solitary oral lesion predominantly
located on the dorsum of the tongue, or on the hard palate, the former statistically significantly associated
with cotrimoxazole. Bullous/erosive (n = 47), aphthous (n = 12), and erythematous (n = 2) morphology
were observed. A considerable number of patients were referred with a prior clinical diagnosis of herpes
simplex and Behcets disease; some of them were already receiving long-term treatment with acyclovir and
colchicine, respectively.

Limitations: The main limitation of the present study resides in its retrospective design.

Conclusions: Isolated oral lesions, aphthous lesions, severe bullous/erosive lesions, and the absence of
residual pigmentation are the main features that may cause difficulties in the differential diagnosis. It is
important to differentiate dysmenorrhea-related monthly attacks of oral FDE in female patients caused by
nonsteroidal anti-inflammatory drugs from menstruation-triggered attacks of herpes simplex infection, and
isolated orogenital aphthous FDE from Behcets disease, especially in countries with a high frequency of
the disease in order to prevent irrelevant therapies. ( J Am Acad Dermatol 10.1016/j.jaad.2012.08.019.)

Key words: behcets disease; bullous; differential diagnosis; erosive; fixed drug eruption; gingival; herpes;
mucosal; oral; palate; tongue.

INTRODUCTION
Abbreviations used:
Fixed drug eruption (FDE) is characterized by
recurrent site-specific lesions on the skin and/or EM: erythema multiforme
FDE: fixed drug eruption
mucosa each time the responsible drug is taken. Oral NSAID: nonsteroidal anti-inflammatory drug
mucosal lesions often accompany the characteristic
skin lesions, but sometimes they may occur alone or in
combination with genital/other mucosal involvement. different clinical manifestations of oral mucosal FDE is
The absence of skin lesions is a diagnostic challenge mainly based on case reports, and a few clinical studies
to the physician because of the wide spectrum of with a relatively small number of cases. The aim of this
differential diagnostic conditions. Our knowledge of study is to present the clinical highlights and the

From the Department of Dermatology and Venereology, Istanbul
University, _Istanbul Medical Faculty.
Funding sources: None.
Conflicts of interest: None declared.
Accepted for publication August 12, 2012.
Reprints not available from the authors.
Correspondence to: Esen Ozkaya, MD, _Istanbul Universitesi
_Istanbul Tp Fak ultesi, Deri ve Z
uhrevi Hastalklar Anabilim
Dal, 34093 _Istanbul, Turkey. E-mail: profeo@istanbul.edu.tr.
Published online October 5, 2012.
0190-9622/$36.00
2012 by the American Academy of Dermatology, Inc.
http://dx.doi.org/10.1016/j.jaad.2012.08.019

e1

e2 Ozkaya J AM ACAD DERMATOL

differential diagnosis of oral mucosal FDE in with regard to age, gender, responsible drug, local-
a relatively large number of patients from Turkey, a ization, number and morphology of oral lesions,
country with a high frequency of the disease.1 additional mucosal and/or skin involvement, num-
ber of attacks, and prior diagnoses of the condition.
METHODS Patients with lip involvement without oral mucosal
This was a methodological, retrospective, cross- lesions were not included.
sectional study based on the analysis of patients data Histopathologic examination was performed
derived from the standard only in the presence of ad-
medical history forms pre- ditional skin lesions. Among
pared for the precise clinical CAPSULE SUMMARY 61 patients, 37 had addi-
documentation of FDE pa- tional skin involvement.
d The literature lacks a comprehensive
tients in our clinic. Skin punch biopsy and
study on oral mucosal FDE.
Between January 1996 and histopathologic examination
May 2011, 269 patients with d Oral FDE presents with bullous/erosive, was performed in 15 of these
suspected FDE were seen. Of aphthous, or erythematous morphology. 37 patients.
them, 78 did not revisit us. In The hard palate and dorsum of the Data were stored and
184 of the remaining 191 pa- tongue are the preferred sites. Aphthous assessed using SPSS for
tients, an oral provocation lesions, severe bullous/erosive lesions, Windows Release 15.0 ver-
test was performed as de- isolated oral involvement, and lack of sion. The chi-square test was
scribed previously,2 after residual pigmentation cause difficulties used for the comparisons. A
written or oral consent of in the differential diagnosis. two-tailed P value less than
patients and of parents or d Recurrent oral lesions in patients with a .05 was taken to indicate a
legal guardians in children, prior diagnosis of menstruation- statistically significant associ-
to establish the causative triggered herpes simplex or Behcets ation. The study was
agent. First, a list of suspected disease should be evaluated carefully assessed and approved by
drugs was prepared for each with regard to FDE. the institutional ethics
individual patient according committee.
to a detailed history of drug
intake. Four weeks after the clearance of the lesions, RESULTS
the oral challenge was performed starting with the The age range of 61 patients (38 females, 23
least suspected drug. Drug challenge was started with males; female/male = 1.7) was 7 to 62 years (median:
one-eighth of a single dose. Doses were increased at 32). Two patients were younger than 10 years old.
12- to 24-hour intervals to one-fourth, one-half, and The occurrence of drug hypersensitivity ranged from
one full dose, if necessary. The test was considered 1 month to more than 10 years (median: 12 months).
positive if the previously involved sites reactivated The number of attacks ranged between one and
with marked erythema/edema, accompanied by more than 10 times. At the time of diagnosis, 6
itching or burning. If no reaction occurred with that patients (9.8%) had had their first attack, whereas 8
drug, the next suspected drug, according to the (13.1%) had had more than 10 attacks. Oral mucosal
patients history, was tested in the same manner after lesions were present since the first FDE attack in 52
an interval of 2 to 3 days. If reactivation occurred with patients (85.2%), whereas 9 patients (14.8%) had
the first drug, the next suspected drug was tested only developed lesions during subsequent attacks. Pain
after the complete subsidence of the first reaction. A and burning were the major symptoms.
drug was considered causative if the challenge test Histopathologic examination, performed in 15 of
was positive. 37 patients with additional skin involvement showed
The diagnosis of FDE could be confirmed in 169 an interface dermatitis characterized by dyskeratosis,
patients, whereas oral provocation test with sus- hydropic degeneration of the basal cells, melano-
pected drugs remained negative in 15 patients. An phages in the papillary dermis, and mononuclear
additional 7 patients were diagnosed according to a perivascular inflammatory infiltration, that was con-
definite history of a single specific drug intake prior sistent with the diagnosis of FDE.
to the eruption and site-specific recurrence.
Photodocumentation was performed in a majority Localization
of patients. Oral mucosal lesions were part of orogenital FDE
Among a total of 176 patients with established in 42 patients (68.8%), either seen as isolated
FDE, 61 patients with oral mucosal involvement orogenital FDE in 14 patients or as orogenital and
comprised the study group. Their files were analyzed skin lesions in 28 patients. Conjunctival and nasal
J AM ACAD DERMATOL
Ozkaya e3

Table I. Involved FDE sites by the causative drugs with special regard to solitary oral lesions
Localization (no.) Causative agent (no.) Significance
Orogenital 1 skin (28) Cotrimoxazole (13), naproxen (11), piroxicam (2), dipyrone (1), NS
etodolac (1)
Orogenital only (14) Naproxen (7), cotrimoxazole (6), piroxicam (1) NS
Oral 1 skin (10) Naproxen (7), cotrimoxazole (2), piroxicam (1) NS
Oral only (9) Naproxen (5), cotrimoxazole (2), phenobarbital (1), ornidazole (1) NS
Oral solitary lesion (14) Cotrimoxazole (8), naproxen (4), piroxicam (1), ornidazole (1) NS
Dorsum of the tongue* (8) Cotrimoxazole* (7), naproxen (1) P = .009 (Fishers
exact test)
Hard palate (5) Naproxen (3), cotrimoxazole (1), piroxicam (1) NS
Inner lip (1) Ornidazole (1)

FDE, Fixed drug eruption; NS, not statistically significant.

*Solitary FDE on dorsum of the tongue was almost exclusively induced by cotrimoxazole.

mucosal involvement accompanied the lesions in 2
patients. Ten patients (16.4%) had oral mucosal and
skin lesions, whereas 9 (14.8%) had only oral muco-
sal involvement. Lips were involved in 33 patients
(54.1%). There was no statistically significant rela-
tionship between lip involvement and accompany-
ing oral mucosal involvement.
Fourteen patients (23%) had a solitary oral lesion.
Solitary oral mucosal lesions (n = 14) were most
frequently located on the dorsum of the tongue
(n = 6), on the hard palate (n = 5), inner lip mucosa
(n = 1), on the ventral (n = 1), and on the lateral side
of the tongue (n = 1). Multiple oral lesions in the
remaining patients were mainly located on the
inner lip and buccal mucosa followed by gingival
mucosa.
Causative agent
The causative agent was verified by oral provo-
cation test in 54 patients (89%) and clinically by the
presence of a definite history of a single specific drug
intake prior to the eruption and site-specific recur-
rence in 7 patients (11%). In a majority of patients,
positive results were achieved with one-eighth of a
single dose. The time required for the positive
reaction to start ranged between 10 minutes and 12
hours. Dissemination of the lesions did not occur
following oral provocation.
Naproxen was the cause of FDE in 30 patients
(49.2%), followed by trimethoprim-sulfamethoxazole
(cotrimoxazole) in 23 patients (37.7%), piroxicam in
4 patients (6.6%), dipyrone in 1 patient (1.6%),
etodolac in 1 patient (1.6%), phenobarbital in 1 patient
(1.6%), and ornidazole in 1 patient (1.6%). Sensitivity
to more than one drug was not observed.
Orogenital lesions were mainly induced by co-
trimoxazole (45.2%) and naproxen (42.9%). Isolated
oral mucosal lesions were mainly induced by na-
proxen (56%), followed by cotrimoxazole (22%) and
other drugs (22%). The differences were statistically
not significant.
Solitary lesions on the tongue (n = 8) were almost
exclusively induced by cotrimoxazole (n = 7; Fishers
exact test, P \ .05) with a female predominance of
80%. Solitary lesions on the hard palate (n = 5) were
caused by naproxen (n = 3), cotrimoxazole (n = 1)
and piroxicam (n = 1). Involved FDE sites and the
causative drugs are shown in Table I.
Morphology
Three major morphological forms were observed
(Table II): Bullous/erosive (n = 47, 77.1%) (Figs 1
and 2), aphthous (n = 12, 19.7%) (Fig 3, A and B),
and erythematous (n = 2, 3.2%) (Fig 3, C and D).
Bullous/erosive lesions were mainly located on the
inner lip and buccal mucosa (n = 27, 57.4%).
Solitary lesions on the dorsum of the tongue and
on the hard palate were almost exclusively bullous/
erosive (Fig 2). Bullous/erosive lesions of the dor-
sum of the tongue were almost exclusively induced
by cotrimoxazole (P \.001). Aphthous lesions were
mainly located on the inner lip mucosa (83.4%).
Erythematous lesions were located on the inner lip
mucosa (n = 1) and the dorsum of the tongue (n =
1). Oral mucosal lesions healed without residual
pigmentation.
Prior diagnoses
Twenty-seven patients (44.3%) were referred to
our clinic with a prior clinical diagnosis of the
following conditions: Behcets disease in 10 pa-
tients with recurrent aphthous oral FDE and addi-
tional genital involvement, menstruation-triggered
herpes simplex infection in 9 female patients with
oral FDE of bullous/erosive (n = 5) or aphthous
morphology (n = 4) recurring monthly during
menstruation due to oral intake of nonsteroidal
anti-inflammatory drugs (NSAIDs) because of

e4 Ozkaya J AM ACAD DERMATOL

Table II. Different morphologic types of FDE lesions causing difficulties in the clinical differential diagnosis
Morphology (%) Mainly involved site Prior clinical diagnoses (no.)
Bullous/erosive (77.1) Inner lip/buccal mucosa/gingiva Herpes simplex* (5), pemphigus vulgaris (2), erythema
multiforme major (2), erosive oral lichen planus (1),
oral candidiasis (1), food allergy (1), vitamin deficiency (1)
Aphthous (19.7) Inner lip mucosa Behcets diseasey (10; 2 of them received colchicine), herpes
simplex* (4; 2 of them were receiving long-term oral
acyclovir therapy)
Erythematous (3.2) Inner lip mucosa/dorsum of tongue None

FDE, Fixed drug eruption.

*Those patients with a prior clinical diagnosis of herpes simplex infection were female patients who were taking non-steroidal anti-
inflammatory drugs because of dysmenorrhea. The monthly recurrence of lesions during menstruation was erroneously attributed to herpes
simplex infection.
y
Patients with a prior clinical diagnosis of Behcets disease were those with recurrent aphthous orogenital FDE.

Fig 1. Oral mucosal FDE. Mild erosive lesions on the lower lip mucosa (A), severe bullous/
erosive lesions on the upper lip mucosa (B), on the lower lip mucosa (C), and on the palatal
and inner lip mucosa (D). Disseminated bullous/erosive lesions deserve special attention in
order to differentiate the condition from pemphigus vulgaris as well as severe drug eruptions
such as EM major or Stevens-Johnson syndrome.

dysmenorrhea, pemphigus vulgaris in 2 patients
with disseminated bullous/erosive FDE on the
cheek or inner lip mucosa, erythema multiforme
(EM) major in 2 patients, erosive oral lichen planus,
oral candidiasis, food allergy, and vitamin defi-
ciency in 1 patient each mainly with bullous/
erosive FDE (Table II). There was no correlation
between the prior diagnosis and the number of
attacks.
Two of 10 patients with the prior clinical
diagnosis of Behcets disease were given
colchicine, and 2 of 9 patients with the prior clinical
diagnosis of menstruation-triggered herpes sim-
plex were receiving long-term oral acyclovir ther-
apy. However, none of the patients improved on
therapy with colchicine or acyclovir. In these pa-
tients, the correct diagnosis of FDE was made by
establishing the causative drug by oral provocation.
No other attack was observed upon avoidance of the
causative drug. The medications, prescribed by the
referring physician, were stopped after the correct
diagnosis of FDE.
J AM ACAD DERMATOL
Ozkaya e5

Fig 2. Oral mucosal FDE. Solitary bullous/erosive lesion on dorsum of the tongue (A and B)
and on the hard palate (C and D) (arrows). Solitary oral lesions in these locations seem to be
highly suggestive of oral mucosal FDE.

DISCUSSION cotrimoxazole in our study. Moreover, naproxen

A review of the literature primarily focused on
oral mucosal FDE revealed less than 40 cases
mainly reported as single case reports from India
and Spain (Table III).3-19 Similar to our findings,
the considerable number of solitary oral FDE
mainly involving the hard palate and the dorsum
of the tongue was striking. However, the inducer
drugs were variable. Solitary FDE on the dorsum
of the tongue was almost exclusively induced by
was the main inducer of solitary FDE on the
palatal mucosa. Cotrimoxazole and naproxen are
known as the leading causes of FDE in our
country.2,20
The bullous/erosive type of lesions predominated
in previous reports, followed by erythematous le-
sions. In our study, however, aphthous lesions were
the second most frequent morphologic type that had
not been reported previously.

e6 Ozkaya J AM ACAD DERMATOL

Fig 3. Oral mucosal FDE. Multiple aphthous lesions on lower lip mucosa (A), solitary aphthous
lesion on buccal mucosa (B), solitary erythematous lesion on lower lip mucosa (C), and solitary
erythematous lesion on dorsum of tongue with central bullae (D). Aphthous lesions deserve
special attention in order to differentiate the condition, especially from herpes simplex
infection or Behcets disease.

A previous study from Pakistan reported 17 of 450
FDE cases with oral mucosal involvement.21 Buccal
mucosa, gums, soft and hard palate, floor of the
mouth, undersurface of the tongue, and posterior
pharyngeal wall were affected, but other character-
istic features of these patients were not mentioned.21
Residual pigmentation was not observed in our
study, and it has been reported rarely previously.5,6
Indeed, it is usually absent in oral mucosal FDE
lesions or less obvious than in skin lesions.22 The
lingual mucosa is known as the rarest site to show
melanin.23
Isolated mucosal FDE without additional skin
involvement is a rare finding.3,4 The diagnosis of
FDE with isolated oral mucosal involvement is al-
ways a challenge to the physician. A solitary bullous/
erosive lesion should be distinguished from major
aphthous ulcer, primary or secondary syphilitic le-
sions (eg, chancre, mucous plaque) or irritant lesions
such as thermal burns. On the other hand, it might be
difficult to differentiate multiple erosive FDE from
pemphigus vulgaris or bullous drug eruptions such
as EM major or Stevens-Johnson syndrome.
Histopathologic examination of skin lesions, per-
formed in 15 patients, showed an interface derma-
titis. Characteristic morphology of the skin lesions,
history of site-specific attacks, and reactivation of old
lesions upon oral challenge helped to diagnose
our cases as FDE and to differentiate it from
drug-induced recurrent EM or a lichenoid drug
eruption with similar histopathologic findings.
Round to oval, sharply demarcated, red to livid,
slightly elevated plaques of 4 to 5 cm in diameter
were characteristic skin lesions for FDE, whereas
numerous, smaller, typical or atypical targetoid le-
sions, or shiny flat papules would be expected in
drug-induced EM or lichenoid drug eruption, re-
spectively. Oral mucosal lesions may accompany as
reticular and/or erosive lesions in lichenoid drug
eruption, or as disseminated bullous/erosive lesions
accompanied by fever and often malaise in more
severe forms of drug-induced EM, that is EM major,
Stevens-Johnson syndrome. In our patients, the
course was uncomplicated with lack of fever and
systemic symptoms. Site-specific recurrence of the
lesions by therapeutic or diagnostic rechallenge with
the inducer drug is the main differential diagnostic
finding of FDE. In contrast, recurrent lesions in drug-
induced EM or lichenoid drug eruption show no
predilection for previously involved sites.
The most striking finding in our study was that
female patients with dysmenorrhea-related recurrent
 J AM ACAD DERMATOL
Table III. Overview of the previously reported cases with oral mucosal FDE (excluding lips)
Additional involvement Inducer established
Author (country) No. of cases No. of lesions Localization (no. of cases) Morphology (S/G/O) (no. of cases) Inducer by (no. of cases) RP
3
Kanwar (India) 1 Solitary Junction of hard/soft palate B/E No Novalgin tablet OPT NM
Browne4 (Nigeria) 20 NM Hard palate (2), gingival (1), NM S, O (conjunctival, NM History/TPT/OPT *NM
tongue (1), buccal (16) nasal mucosa)
Tagami5 (Japan) 1 Multiple Dorsum of tongue Erythematous No Aminopyrine OPT Yes
Westerhof6 (Holland) 1 Multiple Dorsum of tongue B/E (ulcerations) No Heroin No Yes
(presumably)
Jain7 (India) 2 NM Tongue (1), hard palate (1) B/E No NM OPT NM
Mahendra8 (India) 1 Solitary Hard palate B/E No Fluconazole OPT NM
Heikkila9 (Finland) 1 Multiple Oral mucosa B/E S Fluconazole TPT NM
Handisurya10 (Austria) 2 Multiple Oral mucosa and tongue B/E S (2), O (1: conjunctival) Mefenamic acid TPT (1), OPT (1) NM
Montoro11 (Spain) 1 Multiple Oral mucosa B/E (ulcerations) S, G Piroxicam TPT No
Gupta12 (India) 1 Solitary Lower lip mucosa B/E No Ornidazole OPT NM
Gazquez13 (Spain) 1 Multiple Oral mucosa, tongue Erythematous S Quinine OPT No
Alonso14 (Spain) 1 Solitary Dorsum of tongue Erythematous No Clarithromycin OPT Yes
Alvarez Santullano15 1 Multiple Oral mucosa, tongue, palate B/E, erythematous S Ibuprofen TPT NM
(Spain)
Gupta16 (India) 1 Solitary Hard palate B/E No Gabapentin OPT NM
Moreno Escobosa17 1 Solitary Hard palate Erythematous S Trimethoprim OPT NM
(Spain)
Murray18 (USA) 1 Solitary Hard palate B/E No Tetracycline Definite history NM
Naik19 (India) 1 2 Dorsum of tongue B/E S Erithromycin No NM
(presumably)
This study (Turkey) 61 Multiple (47), See Tables I and II B/E (47), aphthous (12), See Table I See Table I OPT (54)/Definite No
solitary (14) erythematous (2) history (7)

B/E, Bullous/erosive; G, genital mucosa; NM, not mentioned; O, other mucosa; OPT, oral provocation test; RP, residual pigmentation; S, skin; TPT, topical provocation tests; these were performed in
healed skin lesions.
*Difficult to establish in deeply pigmented patients.

Ozkaya
e7

e8 Ozkaya
oral FDE from NSAIDs were frequently misdiag-
nosed as menstruation-triggered herpes simplex. such as Turkey. Therefore, a high degree of suspi-
The monthly attacks had even led to long-term oral
acyclovir therapy in 2 patients. Recurrent orogenital
aphthous lesions, on the other hand, were misdiag-
nosed as Behcets disease in 10 patients, leading to
the start of treatment with colchicine in 2 patients. In
all these patients, the correct diagnosis of FDE was
made by establishing the causative drug by oral
provocation.
Systemic provocation is the gold standard for
identifying the causative drug in FDE. It is a safe and
still the most reliable method for the diagnosis of FDE
with a high sensitivity and specificity. However, it
may lead to generalized bullous lesions in some
cases. Therefore the suspected drug should be
administered in graded doses starting with a sub-
therapeutic dose (eg, one-eighth of a single dose)
until the full therapeutic dose is achieved. This would
elicit a positive reaction at the lowest possible dose.
When multiple drugs are suspected, it is advisable to
start with the least susceptible drug. Only one drug
should be tested at a time. The optimal time point for
systemic provocation is not defined, but it is recom-
mended to wait at least 4 weeks after resolution of
signs and symptoms to avoid false-negative results
because of a refractory period.2 Topical provocation
in previously involved FDE sites would be a safer
first-step method, especially for children and in cases
of generalized bullous FDE; however, it is not stan-
dardized and has a variable sensitivity.
In conclusion, this was a comprehensive study
investigating different clinical forms of oral mucosal
FDE which cause difficulties in establishing the
correct diagnosis. As a first step, one should always
look for additional skin involvement that is usually
more characteristic for FDE. In the absence of addi-
tional skin involvement, the location and morphol-
ogy of the oral mucosal lesion might help: Solitary
bullous/erosive lesions on the dorsum of the tongue
or on the hard palate might be highly suggestive of
FDE. Naproxen and co-trimoxazole were the main
inducers, the latter significantly associated with sol-
itary FDE on the dorsum of the tongue. However, the
inducer drugs may vary from country to country.
Isolated oral involvement, aphthous lesions, se-
vere bullous/erosive lesions, the absence of residual
pigmentation, and the wide spectrum of differential
diagnostic conditions may cause difficulties in the
diagnosis of oral mucosal FDE. It is important to
differentiate dysmenorrhea-related monthly attacks
of oral mucosal FDE due to NSAIDs in female
patients from menstruation-triggered attacks of her-
pes simplex infection and isolated orogenital aph-
thous FDE from Behcets disease, especially in
J AM ACAD DERMATOL
countries with a high frequency of the disease,
cion and exclusion of other differential diagnostic
conditions are sine qua non for a correct diagnosis of
oral mucosal FDE to prevent patients from receiving
irrelevant treatments.
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