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© 2022 Journal of Family Medicine and Primary Care | Published by Wolters Kluwer ‑ Medknow 2226
Introduction
Misoprostol is a prostaglandin E1 analogue with widespread
application in obstetrics and gynaecology. Although originally
approved for treating NSAID‑induced peptic ulcer, it has
broader application in reproductive health for various
indications including medical abortion, medical management
of missed and incomplete abortion, induction of labour, for
prevention and treatment of postpartum haemorrhage and also
pre‑instrumentation dilatation of the cervix prior to dilatation
and curettage, hysteroscopy etc.[1] It can be administered orally,
buccally, sublingually, perrectally and pervaginally. The dosage
and route of administration varies according to the indication
of use. Misoprostol though considered a very well tolerated
commonly used drug with minimal and transient side effects,
we encountered a rare case of life‑threatening hypersensitivity
reaction to sublingual misoprostol administered for rst trimester
medical abortion.
Case Report
A 34‑year‑old, G2P2L1, presented at 6 weeks of gestational age
for medical termination of pregnancy for social reasons. Proper
evaluation and ultrasound conrmation of intrauterine location
of pregnancy was done. She was not having hypertension,
diabetes or any other comorbidity. She gave no history of allergy
to any food or drug.
After proper counselling, she opted for medical abortion. Tablet
Misoprostol 800 microgram was administered sublingually 48 h
after an oral dose of 200 mg of tablet mifepristone. Within
20 min of sublingual misoprostol, patient started having itching
inside the oral cavity, in the buccal mucosa, tongue, palate and
lips and also in both the palms with mild shivering. The itching
sensation progressed rapidly and she started feeling heaviness in
the tongue with difculty in deglutition. On general examination,
she was found to be conscious and oriented, afebrile with
a temp of 98°F, pulse rate of 116/min, blood pressure of
130/70 mmHg, respiratory rate of 18/min and SpO2 of 97%
in room air. There was no stridor and chest was bilaterally clear
on auscultation. She had facial ushing, both the upper and
lower lips were oedematous with gross swelling of the tongue.
A rare case of misoprostol hypersensitivity
Rituparna Das1, Subrat Panda1, Nalini Sharma1, Prakash Deb2
Departments of 1Obstetrics and Gynaecology and 2Anaesthesia, Critical Care and Pain, NEIGRIHMS, Shillong, Meghalaya,
India
Abs tr Ac t
Medical abortion using mifepristone‑misoprostol regimen has been considered to be a safe and effective method for pregnancy
termination. Misoprostol is a frequently used well tolerated drug with mild and transient side effects. Considering the safety profile
mifepristone‑misoprostol regimen has also been advocated by many for home‑based medical abortion. However, we report herein
a rare case of hypersensitivity reaction to sublingual misoprostol administered for first trimester medical abortion, where timely
diagnosis and prompt intervention prevented life‑threatening airway obstruction. The possibility of such rare event should be kept
in mind and included in patient counselling and information especially for those who opt for outpatient abortion care so that they
can seek medical help at the earliest.
Keywords: Adverse effects, hypersensitivity, medical abortion, misoprostol
Case Report
Access this article online
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Website:
www.jfmpc.com
DOI:
10.4103/jfmpc.jfmpc_1301_21
Address for correspondence: Dr. Prakash Deb,
Quarter B8F, NEIGRIHMS Campus, NEIGRIHMS, Shillong,
Meghalaya, India.
E‑mail: prox.deb@gmail.com
How to cite this article: Das R, Panda S, Sharma N, Deb P. A rare case
of misoprostol hypersensitivity. J Family Med Prim Care 2022;11:2226-7.
This is an open access journal, and articles are distributed under the terms of the Creative
Commons Attribution‑NonCommercial‑ShareAlike 4.0 License, which allows others to
remix, tweak, and build upon the work non‑commercially, as long as appropriate credit is
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For reprints contact: WKHLRPMedknow_reprints@wolterskluwer.com
Received: 30‑06‑2021 Revised: 14‑12‑2021
Accepted: 20‑12‑2021 Published: 14‑05‑2022
Das, et al.: A case of misoprostol hypersensitivity
Journal of Family Medicine and Primary Care 2227 Volume 11 : Issue 5 : May 2022
Immediately, injection hydrocortisone 200 mg and injection
pheniramine 22.75 mg were administered slowly intravenously
on suspicion of hypersensitivity to misoprostol. Gradually, the
itching sensation, swelling of the lips and tongue and difculty
in deglutition started decreasing with complete resolution of
the symptoms in the next 3 h. Within an hour of the sublingual
misoprostol, she also started having pain in the abdomen and
bleeding per vaginum with passage of eshy mass. Expulsion of
abortus was completed in the next 5 h when her pain subsided
and bleeding decreased. She continued to have bleeding per
vaginum for the next 6 days. On follow‑up, 2 weeks later, she
was absolutely ne and conrmation of complete abortion was
done by clinical examination and ultrasonography.
Discussion
Medical abortion using mifepristone and misoprostol regimen
has been considered a safe and effective method of pregnancy
termination.
[2]
The U.S. Food and Drug Administration
approves use of both the drugs for medical abortion up
to 70 days of gestation.
[3]
WHO recommends the use of
200 mg mifepristone orally followed by 24 to 48 h later by 800
micrograms of misoprostol administered vaginally, sublingually
or buccally for rst trimester medical abortion.
[4]
Misoprostol is generally well tolerated with occasional mild
side effects like nausea, vomiting, diarrhea, abdominal pain,
headache, dizziness, fever and chills.
[1,2]
The overall occurrence
of adverse events reported with medical abortion is rare (0.3%).
[2]
Considering the safety prole, mifepristone‑misoprostol regimen
has also been advocated even for home‑based and outpatient
medical abortion services.
[5]
However, in our case, sublingual misoprostol led to life‑threatening
hypersensitivity reaction. On literature, search reports of such
hypersensitivity reaction is sparse and only three such cases
could be found. Madan et al. reported a case of hypersensitivity
to vaginal misoprostol administered for medical management
of missed abortion.
[6]
Another case of severe hypersensitivity
reaction occurred to sublingual misoprostol used for prevention
of postpartum haemorrhage.
[7]
This rare adverse effect is not
limited to pregnant women and a case of anaphylactic shock has
also been reported following vaginal misoprostol administered for
cervical ripening to a non‑pregnant women posted for hysteroscopic
myomectomy.
[8]
In our patient, misoprostol has been found to successfully induce
abortion; however, the patient developed serious hypersensitivity
reaction which with timely diagnosis and prompt management
prevented life‑threatening airway obstruction.
Misoprostol being a frequently used drug at all levels of health
care services including its use for home‑based abortion awareness
of primary care providers and family physicians about this rare
hypersensitivity reaction is vital as early diagnosis and timely
intervention can prevent grave consequences.
Thus, misoprostol though considered a very safe drug, possibility
of rare and life‑threatening hypersensitivity reaction should be
kept in mind. Appropriate counselling about such rare events
should be done to all women especially to those who opt for
home‑based medical abortion so that they can seek medical help
at the earliest.
Declaration of patient consent
The authors certify that they have obtained all appropriate
patient consent forms. In the form the patient (s) has/have
given his/her/their consent for his/her/their images and other
clinical information to be reported in the journal. The patients
understand that their names and initials will not be published and
due efforts will be made to conceal their identity, but anonymity
cannot be guaranteed.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conicts of interest.
References
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induced convulsion‑ A rare side effect of misoprostol. J Clin
Diagn Res 2017;11:QD01‑2.
2. American College of Obstetricians and Gynecologists.
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Practice Bulletin No. 225. Obstet Gynecol 2020;136:e31‑47.
3. U.S. Food and Drug Administration. Mifeprex (mifepristone)
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Patientsand Providers. Silver Spring, MD: FDA; 2018.
Available from: https://www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatients and
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