Drug Safety Information for REMERON SOLTAB (Mirtazapine)

Safety-related Labeling Changes for REMERON (MIRTAZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for REMERON (MIRTAZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for REMERON SOLTAB (MIRTAZAPINE) Rx Drug: FDA Link

Safety-related Labeling Changes for REMERON SOLTAB (MIRTAZAPINE) Rx Drug: FDA Link

Adverse Drug Reactions for REMERON SOLTAB* (Mirtazapine)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with REMERON SOLTAB
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
4Drug interaction1121
8Completed suicide936
10Confusional state933
12Drug ineffective907
17Toxicity to various agents821
20Suicide attempt750

* This side effect also appears in "Top 10 Side Effects of REMERON SOLTAB " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking REMERON SOLTAB
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
2Product used for unknown indication13139
4Sleep disorder*1653
5Major depression*1176
7Antidepressant therapy560
8Bipolar disorder475
9Schizoaffective disorder404
10Depressed mood359

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for REMERON SOLTAB

Total Reports Filed with FDA: 123656

Number of FDA Adverse Event Reports by Patient Age for REMERON SOLTAB

Total Reports Filed with FDA: 123656*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Mirtazapine (Norset, Remergil, Remeron soltab, Zispin, Remeronsoltab, Rexer, Remeron, Mirtazapine)

Charts are based on 123656 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and REMERON SOLTAB Reviews and Review Summary .

Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.

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