FDA label 36d2ea29-459a-6ac9-e054-00144ff88e88

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
36d2ea29-4599-6ac9-e054-00144ff88e88
SPL ID
36d2ea29-459a-6ac9-e054-00144ff88e88
Version
2
Effective date
2016-07-04
Source export date
2026-11-06
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:48:04

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: • Primary pulmonary hypertension [ see Warnings and Precautions ( 5.2 ) ] • Valvular heart disease [ see Warnings and Precautions ( 5.3 ) ] • Effect on the ability to engage in potentially hazardous tasks [ see Warnings and Precautions ( 5.5 ) ] • Withdrawal effects following prolonged high dosage administration [ see Drug Abuse and Dependence ( 9.3 ) ] The following adverse reactions to phentermine have been identified: Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS ), palpitation, tachycardia, elevation of blood pressure. Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses. Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic: Urticaria. Endocrine: Impotence, changes in libido.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.