Drug Safety Information for LIBRIUM (Chlordiazepoxide hydrochloride)

Adverse Drug Reactions for LIBRIUM* (Chlordiazepoxide hydrochloride)

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 LIBRIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Toxicity to various agents168
2Completed suicide148
3Nausea133
4Dizziness*125
5Drug abuse118
6Pain110
7Vomiting104
8Anxiety103
9Headache100
10Fall99
11Asthenia99
12Drug ineffective97
13Dyspnoea96
14Fatigue95
15Death92
16Diarrhoea92
17Insomnia91
18Tremor88
19Depression84
20Hypertension78

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

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

Reason # of FDA Reports
1Product used for unknown indication1418
2Anxiety*590
3Alcohol withdrawal syndrome223
4Muscle relaxant therapy78
5Alcohol abuse76
6Depression66
7Bladder spasm60
8Insomnia58
9Panic attack56
10Abdominal discomfort56

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


Types of Adverse Events for LIBRIUM

Total Reports Filed with FDA: 12653


Number of FDA Adverse Event Reports by Patient Age for LIBRIUM

Total Reports Filed with FDA: 12653*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Chlordiazepoxide hydrochloride (Chlordiazachel, A-poxide, Lygen, Clordiazepoxido, Chlordiazepoxide, Librium)

Charts are based on 12653 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 LIBRIUM Reviews and Review Summary .

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.