Drug Safety Information for PHENTERMINE HYDROCHLORIDE (Phentermine hydrochloride)

REMS for QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE) Rx Drug: FDA Link

FDA Risk Evaluation and Mitigation Strategy REMS

Safety-related Labeling Changes for QSYMIA (PHENTERMINE HYDROCHLORIDE; TOPIRAMATE) Rx Drug: FDA Link

Adverse Drug Reactions for PHENTERMINE HYDROCHLORIDE* (Phentermine 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 PHENTERMINE HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*256
2Nausea*168
3Anxiety161
4Injury160
5Drug ineffective*159
6Cholecystitis chronic142
7Deep vein thrombosis124
8Pulmonary embolism112
9Emotional distress102
10Cholelithiasis101
11Depression100
12Headache*98
13Dyspnoea95
14Fatigue90
15Vomiting88
16Abdominal pain84
17Chest pain81
18Dizziness*80
19Weight increased79
20Drug abuse76

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

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

Reason # of FDA Reports
1Weight decreased*1453
2Product used for unknown indication884
3Weight control532
4Obesity451
5Decreased appetite258
6Medical diet126
7Appetite disorder103
8Weight loss diet66
9Weight increased58
10Asthenia32

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


Types of Adverse Events for PHENTERMINE HYDROCHLORIDE

Total Reports Filed with FDA: 10620


Number of FDA Adverse Event Reports by Patient Age for PHENTERMINE HYDROCHLORIDE

Total Reports Filed with FDA: 10620*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Phentermine hydrochloride (Suprenza, Ona-mast, Oby-trim, Obestin-30, Phentermine, Tora, Wilpo, Adipex-p, Fastin)

Charts are based on 10620 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.