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.
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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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.
What are the most common Misoprostol adverse events reported to the FDA?
Abortions And Stillbirth | 978 (13.83%) |
Vascular Hemorrhagic | 948 (13.4%) |
Gastrointestinal Signs | 493 (6.97%) |
Anemias Nonhemolytic And Marrow Dep... | 392 (5.54%) |
Neurological | 345 (4.88%) |
Infections - Pathogen Unspecified | 333 (4.71%) |
Pregnancy, Labour, Delivery And Pos... | 323 (4.57%) |
Menstrual Cycle And Uterine Bleedin... | 271 (3.83%) |
Muscle | 239 (3.38%) |
Body Temperature Conditions | 178 (2.52%) |
Chemical Injury And Poisoning | 100 (1.41%) |
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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.
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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Label | Labeler | Effective |
---|---|---|
Misoprostol | PD-Rx Pharmaceuticals, Inc. | 15-OCT-09 |
Arthrotec | Rebel Distributors Corp. | 10-NOV-09 |
Cytotec | Apotheca, Inc | 01-APR-10 |
Misoprostol | Apotheca, Inc. | 15-APR-10 |
Cytotec | G.D. Searle LLC | 01-MAR-11 |
Cytotec | PD-Rx Pharmaceuticals, Inc. | 01-MAR-11 |
Arthrotec | PD-Rx Pharmaceuticals, Inc. | 28-JUL-11 |
Arthrotec | Physicians Total Care, Inc. | 17-JAN-12 |
Misoprostol | H.J. Harkins Company, Inc. | 19-JAN-12 |
Arthrotec | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | 23-FEB-12 |
Cytotec | Cardinal Health | 04-MAY-12 |
Diclofenac Sodium And Misoprostol | Greenstone LLC | 12-JUN-12 |
Arthrotec | STAT Rx USA LLC | 13-JUN-12 |
Diclofenac Sodium And Misoprostol | Watson Laboratories, Inc. | 17-JUL-12 |
Misoprostol | IVAX Pharmaceuticals, Inc. | 30-AUG-12 |
Misoprostol | GAVIS Pharmaceuticals, LLC | 23-OCT-12 |
Misoprostol | PD-Rx Pharmaceuticals, Inc. | 05-NOV-12 |
Misoprostol | Novel Laboratories, Inc. | 05-NOV-12 |
Misoprostol | Greenstone LLC | 11-DEC-12 |
Diclofenac Sodium And Misoprostol | AvKARE, Inc. | 14-DEC-12 |
Misoprostol | GenBioPro Inc | 02-JAN-13 |
Misoprostol | Bryant Ranch Prepack | 18-JAN-13 |
Arthrotec | G.D. Searle LLC Division of Pfizer Inc | 13-MAR-13 |
Misoprostol | Pharmacist Pharmaceutical, LLC | 12-APR-13 |
Diclofenac Sodium And Misoprostol | Watson Laboratories, Inc. | 03-MAY-13 |
What Misoprostol safety concerns are being reported by doctors and researchers in the medical literature?
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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