This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Misoprostol and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (399)
Death (1)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Haemorrhage (176),
Abortion Incomplete (174),
Anaemia (62),
Muscle Spasms (44),
Pain (41),
Pregnancy (41),
Menorrhagia (28),
Dizziness (24),
Vomiting (21),
Syncope (18),
Pyrexia (17),
Nausea (15)
Below are a few examples of reports where side effects / adverse reactions may be related to Misoprostol. For a complete list or a specific selection of reports, please use the links above.
Possible Misoprostol side effects in 57 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 57 year old female, weighing 77.1 kg (169.6 pounds)
Reactions: Blood Cholesterol Increased
Drug(s) suspected as cause:
Diclofenac Potassium
Dosage: 50 mg, 2x/day
Indication: Rheumatoid Arthritis
Misoprostol
Dosage: 200 ug, 2x/day
Indication: Rheumatoid Arthritis
Other drugs received by patient: Carisoprodol; Omeprazole Magnesium; Prednisone; Estradiol; Folic Acid; Aspirin; Fish OIL; Hydrocodone Bitartrate + Acetaminophen
Possible Misoprostol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: female
Reactions: Cleft LIP and Palate, Cardiac Murmur, Nose Deformity, Developmental Delay, Hypertelorism of Orbit, Emotional Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetaminophen
Acetaminophen
Indication: Foetal Exposure During Pregnancy
Butorphanol Tartrate
Indication: Foetal Exposure During Pregnancy
Lamictal
Indication: Foetal Exposure During Pregnancy
Loratadine
Indication: Foetal Exposure During Pregnancy
Misoprostol
Indication: Foetal Exposure During Pregnancy
Nasonex
Indication: Foetal Exposure During Pregnancy
Phenobarbital TAB
Indication: Foetal Exposure During Pregnancy
Prevacid
Indication: Foetal Exposure During Pregnancy
Promethazine HCL
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Other drugs received by patient: Multi-Vitamins; Ferrous Gluconate
Possible Misoprostol side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22
Patient: 24 year old female
Reactions: Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-07-27
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-07-28
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: 27 year old female
Reactions: Haemorrhage, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion
Start date: 2012-06-20
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in 20 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: 20 year old female
Reactions: Haemorrhage, Anaemia, Abortion Incomplete
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-01-10
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-01-11
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 28 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: 28 year old female
Reactions: Abdominal Pain, Haemorrhage, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-01-19
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-01-20
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15
Patient: 27 year old female
Reactions: Haemorrhage, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-13
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-04-14
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10
Patient: 26 year old female
Reactions: Syncope, Haemorrhage, Anaemia
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-20
Misoprostol
Dosage: 800 mcg, vaginal
Start date: 2012-04-21
Possible Misoprostol side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Anxiety, Maternal Exposure During Pregnancy, Depression
Drug(s) suspected as cause:
Acetaminophen
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Butorphanol Tartrate
Indication: Product Used FOR Unknown Indication
Lamictal
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Loratadine
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Misoprostol
Indication: Product Used FOR Unknown Indication
Nasonex
Indication: Product Used FOR Unknown Indication
Phenobarbital TAB
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Prevacid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Promethazine Hydrochloride
Indication: Product Used FOR Unknown Indication
Topamax
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Vitamins (Unspecified); Ferrous Gluconate
Possible Misoprostol side effects in 24 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient: 24 year old female
Reactions: Fatigue, Uterine Tenderness, Nausea, Fallopian Tube Perforation, Haemorrhage, Musculoskeletal Pain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-10
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31
Patient: 33 year old female
Reactions: Abortion Incomplete, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-05-04
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-05-05
Other drugs received by patient: Doxycycline HCL
Possible Misoprostol side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: female
Reactions: Aphasia, Tremor, Feeling Cold
Drug(s) suspected as cause:
Misoprostol
Other drugs received by patient: Lipitor; Vitamin D
Possible Misoprostol side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 26 year old female
Reactions: Back Pain, Pelvic Inflammatory Disease, Haemorrhage, Abortion Incomplete
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-01-21
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-01-22
End date: 2012-01-24
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 25 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 25 year old female
Reactions: Pelvic Inflammatory Disease
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2011-02-01
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2011-02-02
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 17 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 17 year old female
Reactions: Pain, Abortion Incomplete
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-02-16
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 22 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 22 year old female
Reactions: Haemorrhage, Abortion Incomplete
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2011-07-22
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2011-07-23
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 32 year old female
Reactions: Pain
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-07
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-04-08
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 22 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 22 year old female
Reactions: Haemorrhage
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-04
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-04-05
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 28 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 28 year old female
Reactions: Haemorrhage, Anaemia
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-02-10
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-02-11
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-02-20
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 33 year old female
Reactions: Abdominal Pain Lower, Haemorrhage, Chills, Abortion Incomplete, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-03-02
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-03-02
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 35 year old female
Reactions: Abortion Incomplete
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-05-03
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-05-10
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-05-04
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 38 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 38 year old female
Reactions: Pregnancy
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-07
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 40 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 40 year old female
Reactions: Haemorrhage, Pelvic Pain, Muscle Spasms
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-03-01
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: HAS Blood Pressure Medication and NOT Taking IT; Albuterol; Doxycycline
Possible Misoprostol side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 31 year old female
Reactions: Abortion Incomplete
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-05-30
Misoprostol
Dosage: 800 mcg, vaginal
Start date: 2012-06-01
Possible Misoprostol side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 35 year old female
Reactions: Abortion Incomplete
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-24
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-04-25
End date: 2012-05-15
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 17 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 17 year old female
Reactions: Pregnancy
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-03-29
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-03-31
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 26 year old female
Reactions: Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2011-04-19
Misoprostol
Dosage: 800 mcg, buccal
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 35 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 35 year old female
Reactions: Haemorrhage, Anaemia, Dizziness
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2011-12-09
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2011-12-10
Other drugs received by patient: Doxycycline
Possible Misoprostol side effects in 36 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 36 year old female
Reactions: Abortion Incomplete
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-03-09
Misoprostol
Dosage: 800 mg, vaginal
Start date: 2012-03-11
End date: 2012-03-30
Possible Misoprostol side effects in 28 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19
Patient: 28 year old female
Reactions: Haemorrhage, Abortion Incomplete, Muscle Spasms
Drug(s) suspected as cause:
Mifepristone (Mifeprex)
Dosage: 200 mg, oral
Administration route: Oral
Indication: Abortion Induced
Start date: 2012-04-18
Misoprostol
Dosage: 800 mcg, buccal
Start date: 2012-04-19
Other drugs received by patient: Doxycycline
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