warnings and cautions
5.8 Use in Patients with Hypertension Use caution in prescribing phentermine for patients with even mild hypertension (risk of increase in blood pressure).
FDA label 46e5d39c-90ed-46ae-a35a-55b32c19dce2
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
- SPL set ID
- 8739f879-9af6-4fd6-b8b0-12dc4fee20a0
- SPL ID
- 46e5d39c-90ed-46ae-a35a-55b32c19dce2
- Version
- 1
- Effective date
- 2017-02-28
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:35:06
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 46e5d39c-90ed-46ae-a35a-55b32c19dce2 | id | |
| spl set id | 8739f879-9af6-4fd6-b8b0-12dc4fee20a0 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
5.9 Use in Patients on Insulin or Oral Hypoglycemic Medications for Diabetes Mellitus A reduction in insulin or oral hypoglycemic medications in patients with diabetes mellitus may be required.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
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, palpitation, tachycardia, elevation of blood pressure, ischemic events. Central Nervous System Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Allergic Urticaria. Endocrine Impotence, changes in libido. Adverse events have been reported in the cardiovascular, central nervous, gastrointestinal, allergic, and endocrine systems. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-800-325-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.