Drug Safety Information for SECONAL SODIUM (Secobarbital sodium)
Adverse Drug Reactions for SECONAL SODIUM* (Secobarbital sodium)
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 SECONAL SODIUM
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Drug abuse | 17 |
2 | Fall | 5 |
3 | Death | 4 |
4 | Suicidal ideation | 4 |
5 | Cardiac arrest | 4 |
6 | Product quality issue | 4 |
7 | Respiratory arrest | 4 |
8 | Headache | 4 |
9 | Toxicity to various agents | 4 |
10 | Somnolence* | 4 |
11 | Fatigue | 4 |
12 | Drug hypersensitivity | 4 |
13 | Chest discomfort | 3 |
14 | Nausea | 3 |
15 | Drug ineffective | 3 |
16 | Anxiety | 3 |
17 | Convulsion | 3 |
18 | Poisoning | 3 |
19 | Arthralgia | 3 |
20 | Accidental overdose | 3 |
* This side effect also appears in "Top 10 Side Effects of SECONAL SODIUM " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking SECONAL SODIUM
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Insomnia* | 46 |
2 | Product used for unknown indication | 34 |
3 | Sleep disorder | 24 |
4 | Migraine | 19 |
5 | Analgesic therapy | 6 |
6 | Anxiety | 6 |
7 | Maternal exposure during pregnancy | 4 |
8 | Status epilepticus | 1 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for SECONAL SODIUM
Total Reports Filed with FDA: 350
Number of FDA Adverse Event Reports by Patient Age for SECONAL SODIUM
Total Reports Filed with FDA: 350*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Secobarbital sodium (Secobarbital, Seconal sodium, Sodium secobarbital, Seconal, Secobarbital sodium)
Charts are based on 350 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.
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Historical 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.