Drug Safety Information for TALWIN (Pentazocine lactate)

REMS for Pentazocine (PENTAZOCINE LACTATE) Rx Drug: FDA Link

Shared FDA Risk Evaluation and Mitigation Strategy

Safety-related Labeling Changes for TALWIN NX (PENTAZOCINE LACTATE) Rx Drug: FDA Link

Adverse Drug Reactions for TALWIN* (Pentazocine lactate)

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 TALWIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug hypersensitivity72
2Nausea*53
3Pyrexia48
4Drug abuse45
5Pain42
6Vomiting*41
7Respiratory depression38
8Anaemia37
9Headache35
10Abdominal pain34
11Platelet count decreased34
12Diarrhoea34
13Pneumonia33
14Hypertension31
15Hepatic function abnormal29
16Dyspnoea29
17Death28
18Drug ineffective28
19Blood pressure increased27
20White blood cell count decreased26

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

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

Reason # of FDA Reports
1Pain*507
2Product used for unknown indication395
3Analgesic therapy186
4Abdominal pain*91
5Drug abuse74
6Sedation63
7Premedication41
8Back pain*36
9Procedural pain22
10Anaesthesia19

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


Types of Adverse Events for TALWIN

Total Reports Filed with FDA: 5394


Number of FDA Adverse Event Reports by Patient Age for TALWIN

Total Reports Filed with FDA: 5394*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pentazocine lactate (Pentazocine, Talwin)

Charts are based on 5394 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 TALWIN 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.