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Misoprostol (Misoprostol) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following have been reported as adverse events in subjects receiving Misoprostol Tablets:

Gastrointestinal: In subjects receiving Misoprostol Tablets 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14 to 40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13 to 20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.

Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Misoprostol Tablets (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Misoprostol Tablets is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Misoprostol Tablets with magnesium-containing antacids.

Gynecological: Women who received Misoprostol Tablets during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to Misoprostol Tablets administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (See boxed WARNINGS.)

Elderly: There were no significant differences in the safety profile of Misoprostol Tablets in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients.

Additional adverse events which were reported are categorized as follows:

Incidence greater than 1%: In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving Misoprostol Tablets and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for Misoprostol Tablets and placebo.

Causal relationship unknown: The following adverse events were infrequently reported. Causal relationships between Misoprostol Tablets and these events have not been established but cannot be excluded:

Body as a whole: aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes.

Skin: rash, dermatitis, alopecia, pallor, breast pain.

Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache.

Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis.

Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA).

Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase.

Hypersensitivity: anaphylactic reaction

Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase.

Genitourinary: polyuria, dysuria, hematuria, urinary tract infection.

Nervous system/Psychiatric: anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion.

Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain.

Blood/Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, ESR increased.



REPORTS OF SUSPECTED MISOPROSTOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Misoprostol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Misoprostol side effects / adverse reactions in 44 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-07

Patient: 44 year old female

Reactions: Thrombosis, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Misoprostol
    Dosage: 800 mcg, buccal
    Start date: 2011-08-06

Mifepristone (Mifeprex)
    Dosage: 200 mg, oral
    Administration route: Oral
    Indication: Abortion Induced
    Start date: 2011-08-05



Possible Misoprostol side effects / adverse reactions in 17 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 17 year old female

Reactions: Haemorrhage, Pyrexia, Uterine Haemorrhage

Adverse event resulted in: hospitalization

Suspect drug(s):
Mifepristone (Mifeprex)
    Dosage: 200 mg, oral
    Administration route: Oral
    Indication: Abortion Induced
    Start date: 2010-05-13

Misoprostol
    Dosage: 800 mcg, buccal
    Start date: 2010-05-14

Other drugs received by patient: Doxycycline



Possible Misoprostol side effects / adverse reactions in 16 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 16 year old female

Reactions: Haemorrhage, Anaemia, Abortion Incomplete

Adverse event resulted in: hospitalization

Suspect drug(s):
Mifepristone (Mifeprex)
    Dosage: 200 mg, oral
    Administration route: Oral
    Indication: Abortion Induced
    Start date: 2009-08-03

Misoprostol
    Dosage: 800 mcg, buccal
    Start date: 2009-08-04

Other drugs received by patient: Doxycycline



See index of all Misoprostol side effect reports >>

Drug label data at the top of this Page last updated: 2014-01-15

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