Drug Safety Information for BONTRIL PDM (Phendimetrazine tartrate)

Safety-related Labeling Changes for PHENDIMETRAZINE TARTRATE (PHENDIMETRAZINE TARTRATE) Rx Drug: FDA Link

Adverse Drug Reactions for BONTRIL PDM* (Phendimetrazine tartrate)

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 BONTRIL PDM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pulmonary embolism15
2Pain13
3Anxiety13
4Dyspnoea10
5Depression10
6Weight increased9
7Deep vein thrombosis8
8Chest pain8
9Palpitations8
10Nausea7
11Back pain7
12Overdose7
13Cholecystitis chronic7
14Headache*7
15Emotional distress6
16Cholelithiasis6
17Hypertension6
18Tachycardia6
19Oedema peripheral6
20Injury5

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

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

Reason # of FDA Reports
1Weight decreased*121
2Weight control56
3Product used for unknown indication52
4Medical diet36
5Bipolar disorder32
6Decreased appetite26
7Obesity*16
8Appetite disorder14
9Increased appetite13
10Weight loss diet8

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


Types of Adverse Events for BONTRIL PDM

Total Reports Filed with FDA: 748


Number of FDA Adverse Event Reports by Patient Age for BONTRIL PDM

Total Reports Filed with FDA: 748*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Phendimetrazine tartrate (Adphen, Sprx-105, X-trozine l.a., Phenazine, Cam-metrazine, Alphazine, X-trozine, Phenazine-35, Sprx-3, Melfiat-105, Melfiat, Metra, Statobex, Statobex-g, Di-metrex, Bontril, Phendimetrazine, Bontril pdm, Plegine)

Charts are based on 748 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.