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MISOPROSTOL

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Misoprostol Adverse Events Reported to the FDA Over Time

How are Misoprostol adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Misoprostol, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Misoprostol is flagged as the suspect drug causing the adverse event.

Most Common Misoprostol Adverse Events Reported to the FDA

What are the most common Misoprostol adverse events reported to the FDA?

Haemorrhage
946 (13.37%)
Abortion Incomplete
940 (13.29%)
Anaemia
391 (5.53%)
Pregnancy
320 (4.52%)
Menorrhagia
257 (3.63%)
Muscle Spasms
224 (3.17%)
Pain
196 (2.77%)
Abdominal Pain
180 (2.54%)
Dizziness
175 (2.47%)
Pyrexia
175 (2.47%)
Vomiting
153 (2.16%)
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Nausea
128 (1.81%)
Syncope
116 (1.64%)
Endometritis
111 (1.57%)
Drug Exposure During Pregnancy
90 (1.27%)
Infection
60 (.85%)
Chills
54 (.76%)
Hypotension
53 (.75%)
Asthenia
48 (.68%)
Asthma
44 (.62%)
Rheumatoid Arthritis
43 (.61%)
Osteoarthritis
42 (.59%)
Idiopathic Thrombocytopenic Purpura
41 (.58%)
Dyspnoea
37 (.52%)
Ectopic Pregnancy
37 (.52%)
Headache
37 (.52%)
Vaginal Haemorrhage
34 (.48%)
Fatigue
32 (.45%)
Pelvic Pain
32 (.45%)
Sepsis
31 (.44%)
Pelvic Inflammatory Disease
30 (.42%)
Diarrhoea
28 (.4%)
Off Label Use
28 (.4%)
Hypersensitivity
26 (.37%)
Tachycardia
26 (.37%)
Ruptured Ectopic Pregnancy
25 (.35%)
Swelling
25 (.35%)
Musculoskeletal Stiffness
23 (.33%)
Loss Of Consciousness
22 (.31%)
Uterine Haemorrhage
22 (.31%)
Induced Abortion Failed
21 (.3%)
Drug Ineffective
18 (.25%)
Caesarean Section
16 (.23%)
Death
16 (.23%)
Haemoglobin Decreased
16 (.23%)
White Blood Cell Count Increased
16 (.23%)
Abortion Induced
15 (.21%)
Incorrect Dose Administered
15 (.21%)
Back Pain
14 (.2%)
Cardiac Arrest
14 (.2%)
Incorrect Route Of Drug Administrat...
14 (.2%)
Antepartum Haemorrhage
13 (.18%)
Malaise
13 (.18%)
Post Abortion Infection
13 (.18%)
Rash
13 (.18%)
Urinary Tract Infection
13 (.18%)
Convulsion
12 (.17%)
Drug Ineffective For Unapproved Ind...
12 (.17%)
Tremor
12 (.17%)
Retained Products Of Conception
11 (.16%)
Swelling Face
11 (.16%)
Uterine Disorder
11 (.16%)
Uterine Rupture
11 (.16%)
Vaginal Odour
11 (.16%)
Blood Pressure Decreased
10 (.14%)
Chest Pain
10 (.14%)
Dehydration
10 (.14%)
Dysuria
10 (.14%)
Heart Rate Increased
10 (.14%)
Breast Tenderness
9 (.13%)
Condition Aggravated
9 (.13%)
Drug Interaction
9 (.13%)
Hyperhidrosis
9 (.13%)
Leukocytosis
9 (.13%)
Necrosis
9 (.13%)
Oedema Peripheral
9 (.13%)
Thrombosis
9 (.13%)
Unevaluable Event
9 (.13%)
Vaginitis Bacterial
9 (.13%)
Anxiety
8 (.11%)
Dysmenorrhoea
8 (.11%)
Hypoaesthesia
8 (.11%)
Inappropriate Schedule Of Drug Admi...
8 (.11%)
Metabolic Acidosis
8 (.11%)
Renal Failure Acute
8 (.11%)
Septic Shock
8 (.11%)
Vaginal Discharge
8 (.11%)
Abdominal Pain Lower
7 (.1%)
Clostridial Infection
7 (.1%)
Depression
7 (.1%)
Disseminated Intravascular Coagulat...
7 (.1%)
Fall
7 (.1%)
Foetal Heart Rate Abnormal
7 (.1%)
Haematocrit Decreased
7 (.1%)
Hysterectomy
7 (.1%)
Intra-uterine Death
7 (.1%)
Maternal Drugs Affecting Foetus
7 (.1%)
Orthostatic Hypotension
7 (.1%)
Overdose
7 (.1%)
Post Abortion Complication
7 (.1%)
Shock
7 (.1%)

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This graph shows the top adverse events submitted to the FDA for Misoprostol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Misoprostol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Misoprostol

What are the most common Misoprostol adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Misoprostol, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Misoprostol is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Misoprostol According to Those Reporting Adverse Events

Why are people taking Misoprostol, according to those reporting adverse events to the FDA?

Abortion Induced
121
Product Used For Unknown Indication
60
Drug Use For Unknown Indication
58
Prophylaxis Against Gastrointestina...
39
Rheumatoid Arthritis
29
Abortion
24
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Prophylaxis
19
Labour Induction
18
Pain
15
Osteoarthritis
14
Inflammation
11
Arthralgia
11
Arthritis
10
Gastritis
9
Induced Labour
9
Gastrointestinal Disorder
8
Constipation
8
Off Label Use
7
Adverse Event
7
Gastric Disorder
6
Ill-defined Disorder
5
Pregnancy
5
Premedication
4
Gastritis Prophylaxis
4
Drug Exposure During Pregnancy
4
Back Pain
3
Dysmenorrhoea
3
Postpartum Haemorrhage
3
Abortion Spontaneous
3
Anaesthetic Premedication
3
Metastatic Pain
3
Wound Abscess
3
Bone Pain
2
Gastritis Atrophic
2
Cervix Disorder
2
Pain In Extremity
2
Abdominal Discomfort
2
Musculoskeletal Pain
2
Uterine Haemorrhage
2
Uterine Cervix Dilation Procedure
2
Gastric Mucosal Lesion
2
Duodenal Ulcer
2
Gastric Ulcer
2
Gastroduodenal Ulcer
2
Foetal Exposure During Pregnancy
2
Smear Cervix
1
Abortion Induced Incomplete
1
Abortion Missed
1
Epigastric Discomfort
1
Thrombosis Prophylaxis
1
Hysteroscopy
1

Drug Labels

LabelLabelerEffective
MisoprostolPD-Rx Pharmaceuticals, Inc.15-OCT-09
ArthrotecRebel Distributors Corp.10-NOV-09
Cytotec Apotheca, Inc01-APR-10
MisoprostolApotheca, Inc.15-APR-10
CytotecG.D. Searle LLC01-MAR-11
CytotecPD-Rx Pharmaceuticals, Inc.01-MAR-11
ArthrotecPD-Rx Pharmaceuticals, Inc.28-JUL-11
ArthrotecPhysicians Total Care, Inc.17-JAN-12
MisoprostolH.J. Harkins Company, Inc.19-JAN-12
ArthrotecLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-FEB-12
CytotecCardinal Health04-MAY-12
Diclofenac Sodium And MisoprostolGreenstone LLC12-JUN-12
ArthrotecSTAT Rx USA LLC13-JUN-12
Diclofenac Sodium And MisoprostolWatson Laboratories, Inc.17-JUL-12
MisoprostolIVAX Pharmaceuticals, Inc.30-AUG-12
MisoprostolGAVIS Pharmaceuticals, LLC23-OCT-12
Misoprostol PD-Rx Pharmaceuticals, Inc.05-NOV-12
MisoprostolNovel Laboratories, Inc.05-NOV-12
MisoprostolGreenstone LLC11-DEC-12
Diclofenac Sodium And Misoprostol AvKARE, Inc.14-DEC-12
MisoprostolGenBioPro Inc02-JAN-13
MisoprostolBryant Ranch Prepack18-JAN-13
ArthrotecG.D. Searle LLC Division of Pfizer Inc13-MAR-13
MisoprostolPharmacist Pharmaceutical, LLC12-APR-13
Diclofenac Sodium And MisoprostolWatson Laboratories, Inc.03-MAY-13

Misoprostol Case Reports

What Misoprostol safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Misoprostol. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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