This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cytotec (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 (65)
Death (7)
Life Threatening Events (5)
Disability (6)
Reports by Reaction Type
Off Label Use (11),
Pyrexia (10),
Drug Ineffective FOR Unapproved Indication (8),
Bone Fissure (6),
Chills (5),
Maternal Exposure During Pregnancy (5),
Maternal Exposure Timing Unspecified (5),
Toxic Epidermal Necrolysis (4),
Diarrhoea (4),
Abdominal Pain (3),
Glossodynia (3),
Drug Ineffective (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Cytotec (Misoprostol). For a complete list or a specific selection of reports, please use the links above.
Possible Cytotec side effects in female
Reported by a physician on 2012-08-24
Patient: female, weighing 64.4 kg (141.7 pounds)
Reactions: Back Pain, Diarrhoea, Neck Pain, Chills, Headache, Muscle Spasms, Tremor
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in
Reported by a consumer/non-health professional from Denmark on 2012-08-22
Patient:
Reactions: Umbilical Cord Around Neck, Maternal Exposure During Pregnancy
Adverse event resulted in: death
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a physician from France on 2012-08-14
Patient: female
Reactions: Arthralgia, Bone Fissure, Tibia Fracture
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1998-12-01
Enbrel
Indication: Rheumatoid Arthritis
Start date: 2008-05-01
End date: 2008-10-01
Humira 40 MG / 0.8 ML PRE-Filled Syringe
Indication: Rheumatoid Arthritis
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-02-05
Orencia
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-01-01
Plaquenil
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1994-12-01
Prednisone TAB
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1995-02-20
Prednisone TAB
Administration route: Oral
Start date: 1995-02-20
Protelos
Administration route: Oral
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in 66 year old female
Reported by a consumer/non-health professional from Switzerland on 2012-07-30
Patient: 66 year old female
Reactions: Toxic Epidermal Necrolysis
Adverse event resulted in: death
Drug(s) suspected as cause:
Cefotiam Hydrochloride
Dosage: daily dose 2 g
Indication: Antibiotic Therapy
Start date: 2011-08-19
End date: 2011-08-23
Cytotec
Dosage: 200 mg, unk
Administration route: Oral
Indication: Dyspepsia
Start date: 2011-07-21
End date: 2011-08-24
Fentanyl-100
Dosage: daily dose 2.1 mg
Administration route: Topical
Indication: Analgesic Therapy
Start date: 2011-08-22
End date: 2011-08-24
Mobic
Dosage: daily dose 10 mg
Administration route: Oral
Indication: Analgesic Therapy
Start date: 2011-08-13
End date: 2011-08-24
Naproxen Sodium
Dosage: 100 mg, unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-08-22
End date: 2011-08-25
Prochlorperazine
Dosage: daily dose 10 mg
Indication: Vomiting
Start date: 2011-08-09
End date: 2011-08-24
Sutent
Dosage: daily dose 50 mg
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2011-08-08
End date: 2011-08-22
Possible Cytotec side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-27
Patient: 32 year old female
Reactions: Uterine Hypertonus, Off Label Use, Abdominal Pain, Pyrexia, Sinus Tachycardia, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Other drugs received by patient: Atarax; Nimbex; Lidocaine; Mifegyne; Sufentanil
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: female
Reactions: Off Label Use, Diarrhoea, Vaginal Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-24
Patient:
Reactions: Apgar Score LOW, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-23
Patient:
Reactions: Apgar Score LOW
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 32 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23
Patient: 32 year old female
Reactions: Off Label Use, Uterine Hypertonus, Abdominal Pain, Pyrexia, Hypertension, Sinus Tachycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Other drugs received by patient: Mifegyne; Nimbex; Sufentanil; Atarax; Lidocaine
Possible Cytotec side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-23
Patient: female
Reactions: Off Label Use, Premature Separation of Placenta, Uterine Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-19
Patient:
Reactions: Muscle Spasticity, Neonatal Asphyxia, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 63 year old female
Reactions: Bone Fissure
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Dosage: 35 mg, unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Dosage: unk
Administration route: Oral
Start date: 1998-12-01
Enbrel
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2008-05-01
End date: 2008-10-01
Humira
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Dosage: 7.5 mg, weekly
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-02-05
Orencia
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Dosage: unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-01-01
Plaquenil
Dosage: 400 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1994-12-01
Prednisone TAB
Dosage: 8 mg, 1x/day
Administration route: Oral
Start date: 1995-02-20
Prednisone TAB
Dosage: 5 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1995-02-20
Protelos
Dosage: unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Off Label Use, Diarrhoea, Vaginal Haemorrhage
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-07-18
Patient: female
Reactions: Off Label Use, Haemorrhage, Premature Separation of Placenta
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a physician from France on 2012-07-18
Patient: female
Reactions: Bone Fissure, Tibia Fracture
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1998-12-01
Enbrel
Indication: Rheumatoid Arthritis
Start date: 2008-05-01
End date: 2008-10-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-02-05
Orencia
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-01-01
Plaquenil
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1994-12-01
Prednisone TAB
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1995-02-20
Prednisone TAB
Administration route: Oral
Start date: 1995-02-20
Protelos
Administration route: Oral
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in 63 year old female
Reported by a consumer/non-health professional from France on 2012-07-18
Patient: 63 year old female
Reactions: Bone Fissure
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Administration route: Oral
Start date: 1998-12-01
Enbrel
Start date: 2008-05-01
End date: 2008-10-01
Humira
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Administration route: Oral
Start date: 1996-02-05
Orencia
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Administration route: Oral
Start date: 1996-01-01
Plaquenil
Administration route: Oral
Start date: 1994-12-01
Prednisone TAB
Dosage: also taken 8mg
Administration route: Oral
Start date: 1995-02-20
Protelos
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17
Patient: 63 year old female
Reactions: Bone Fissure
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Dosage: 35 mg, unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Dosage: unk
Administration route: Oral
Start date: 1998-12-01
Enbrel
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2008-05-01
End date: 2008-10-01
Humira
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Dosage: 7.5 mg, weekly
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-02-05
Orencia
Dosage: unk
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Dosage: unk
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-01-01
Plaquenil
Dosage: 400 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1994-12-01
Prednisone TAB
Dosage: 8 mg, 1x/day
Administration route: Oral
Start date: 1995-02-20
Prednisone TAB
Dosage: 5 mg, 1x/day
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1995-02-20
Protelos
Dosage: unk
Administration route: Oral
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in 63 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17
Patient: 63 year old female
Reactions: Bone Fissure
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Actonel
Administration route: Oral
Indication: Osteoporosis
Start date: 2002-06-04
End date: 2010-06-14
Cytotec
Administration route: Oral
Start date: 1998-12-01
Etanercept
Indication: Rheumatoid Arthritis
Start date: 1998-05-01
End date: 1998-10-01
Humira
Indication: Rheumatoid Arthritis
Start date: 2008-10-01
End date: 2009-03-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-02-05
Orencia
Indication: Rheumatoid Arthritis
Start date: 2011-02-01
Pentasa
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1996-01-01
Plaquenil
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1994-12-01
Prednisone TAB
Administration route: Oral
Start date: 1995-02-20
Prednisone TAB
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 1995-02-20
Strontium Ranelate
Administration route: Oral
Indication: Osteoporosis
Start date: 2011-02-18
End date: 2011-09-13
Possible Cytotec side effects in 28 year old female
Reported by a physician from Sweden on 2012-07-16
Patient: 28 year old female
Reactions: Off Label Use, Duodenal Ulcer Perforation, Abortion
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 66 year old female
Reported by a physician from Japan on 2012-07-09
Patient: 66 year old female
Reactions: Toxic Epidermal Necrolysis
Adverse event resulted in: death
Drug(s) suspected as cause:
Cefotiam Hydrochloride
Cytotec
Fentanyl-100
Mobic
Administration route: Oral
Start date: 2011-08-01
End date: 2011-08-01
Naproxen
Prochlorperazine
Sutent
Possible Cytotec side effects in male
Reported by a physician from United States on 2012-06-15
Patient: male
Reactions: Seasonal Allergy, Dysarthria, Asthma
Drug(s) suspected as cause:
Celebrex
Dosage: unk
Cytotec
Dosage: unk
Pristiq
Dosage: unk
Possible Cytotec side effects in 1 year old male
Reported by a consumer/non-health professional from Denmark on 2012-06-13
Patient: 1 year old male
Reactions: Blood PH Increased, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: 66 year old female
Reactions: Hypersensitivity
Adverse event resulted in: death
Drug(s) suspected as cause:
Cytotec
Dosage: unk
Dilantin
Skelaxin
Possible Cytotec side effects in female
Reported by a lawyer from United States on 2012-06-07
Patient: female
Reactions: Swelling Face, Pain in Extremity, Drug Ineffective FOR Unapproved Indication, Pain, Urinary Incontinence, Pyrexia, Headache, Hypoaesthesia, Tremor, Hypoacusis, Auricular Swelling, Neck Pain, Deafness Unilateral, Disturbance in Attention, Vision Blurred, Dizziness
Drug(s) suspected as cause:
Cytotec
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: female, weighing 72.1 kg (158.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Thrombosis, Glossodynia, Hypoaesthesia Oral, Drug Ineffective, Oedema Peripheral, Oropharyngeal Pain, Throat Tightness
Drug(s) suspected as cause:
Cytotec
Administration route: Oral
Indication: Gastric Disorder
Start date: 2012-03-01
End date: 2012-03-01
Dexilant
Indication: Hyperchlorhydria
Start date: 2012-04-01
End date: 2012-04-01
Lovenox
Indication: Thrombosis
Start date: 2012-01-01
End date: 2012-01-01
Warfarin Sodium
Administration route: Oral
Indication: Thrombosis
Start date: 2012-01-01
End date: 2012-04-16
Xarelto
Administration route: Oral
Indication: Thrombosis
Start date: 2012-04-18
End date: 2012-04-20
Other drugs received by patient: Calcium Carbonate; Probiotics; Claritin; Benadryl; Zyrtec; Magnesium Hydroxide TAB; Allegra
Possible Cytotec side effects in male
Reported by a physician from France on 2012-05-17
Patient: male, weighing 3.6 kg (7.9 pounds)
Reactions: Postmature Baby, Maternal Drugs Affecting Foetus, Foetal Heart Rate Deceleration, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Cytotec
Dosage: 0.25 df, 2x/day
Indication: Labour Induction
Start date: 2012-03-24
End date: 2012-03-24
Enbrel
Dosage: 50 mg, weekly
Start date: 2004-07-01
End date: 2011-07-05
Other drugs received by patient: Acetaminophen; Timoferol; Vitamin D
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-14
Patient: female, weighing 72.1 kg (158.7 pounds)
Reactions: Thrombosis, Inappropriate Schedule of Drug Administration, Glossodynia, Hypoaesthesia Oral, Drug Ineffective, Oedema Peripheral, Oropharyngeal Pain, Throat Tightness
Drug(s) suspected as cause:
Cytotec
Administration route: Oral
Indication: Gastric Disorder
Start date: 2012-03-01
End date: 2012-03-01
Dexilant
Indication: Hyperchlorhydria
Start date: 2012-04-01
End date: 2012-04-01
Lovenox
Indication: Thrombosis
Start date: 2012-01-01
End date: 2012-01-01
Warfarin Sodium
Administration route: Oral
Indication: Thrombosis
Start date: 2012-01-01
End date: 2012-04-16
Xarelto
Administration route: Oral
Indication: Thrombosis
Start date: 2012-04-18
End date: 2012-04-20
Other drugs received by patient: Calcium Carbonate; Allegra; Benadryl; Magnesium Hydroxide TAB; Probiotics; Zyrtec; Claritin
Possible Cytotec side effects in male
Reported by a physician from France on 2012-05-10
Patient: male, weighing 3.6 kg (7.9 pounds)
Reactions: Foetal Heart Rate Deceleration, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Cytotec
Dosage: 0.25 df, 2x/day
Indication: Labour Induction
Start date: 2012-03-24
End date: 2012-03-24
Enbrel
Dosage: 50 mg, weekly
Indication: Rheumatoid Arthritis
Start date: 2004-07-01
End date: 2011-07-05
Other drugs received by patient: Vitamin D; Acetaminophen; Timoferol
Possible Cytotec side effects in female
Reported by a consumer/non-health professional from United Kingdom on 2012-05-08
Patient: female
Reactions: Brain Injury, Stillbirth
Drug(s) suspected as cause:
Cytotec
Indication: Labour Induction
Cytotec
Indication: Off Label Use
Possible Cytotec side effects in female
Reported by a physician from United States on 2012-05-07
Patient: female
Reactions: Vomiting, Nausea, Pyrexia, Tremor
Drug(s) suspected as cause:
Cytotec
Dosage: unk
Indication: Prophylaxis
Start date: 2012-04-26
Mirena
Dosage: 20 mcg/24hr, unk
Start date: 2012-04-26
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