Table 4. Adverse events reported by patients who received phentermine orally for 6 months.
| Adverse event | Phentermine | Total (n = 932) | p-value 15 mg vs. 30 mg |
|
|---|---|---|---|---|
| 15 mg (n = 400) | 30 mg (n = 532) | |||
| Cardiac disorders | ||||
| Dyspnea | 1 (0.3) | 3 (0.6) | 4 (0.4) | 0.6 |
| Ear and labyrinth disorders | ||||
| Tinnitus | 1 (0.3) | 4 (0.8) | 5 (0.5) | 0.3 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 2 (0.5) | 13 (2.4) | 15 (1.6) | 0.03 |
| Constipation | 14 (3.5) | 22 (4.1) | 36 (3.9) | 0.7 |
| Dry mouth | 25 (6.3) | 74 (13.9) | 99 (10.6) | < 0.0001 |
| Dyspepsia | 3 (0.8) | 8 (1.5) | 11 (1.2) | 0.4 |
| Nausea | 2 (0.5) | 6 (1.1) | 8 (0.9) | 0.5 |
| Vomiting | 1 (0.3) | 4 (0.8) | 5 (0.5) | 0.4 |
| General disorders and administration site conditions | ||||
| Ataxia | 2 (0.3) | 0 (0) | 2 (0.1) | 0.5 |
| Hyperhidrosis | 4 (1) | 1 (0.2) | 5 (0.5) | 0.2 |
| Irritability | 2 (0.5) | 1 (0.2) | 3 (0.3) | 0.6 |
| Metabolism and nutrition disorders | ||||
| Hyperphagia | 8 (2) | 15 (2.8) | 23 (2.5) | 0.5 |
| Increased appetite | 13 (3.3) | 44 (8.3) | 57 (6.1) | 0.002 |
| Polydipsia | 5 (1.3) | 20 (3.8) | 25 (2.7) | 0.02 |
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 6 (1.6) | 23 (4.4) | 29 (3.1) | 0.1 |
| Neck pain | 1 (0.3) | 4 (0.8) | 5 (0.6) | 0.3 |
| Pain in extremity | 14 (3.5) | 31 (5.8) | 45 (4.8) | 0.2 |
| Neoplasms benign, malignant, and unspecified | ||||
| Acanthosis nigricans | 2 (0.5) | 22 (4.1) | 24 (2.6) | < 0.0001 |
| Nervous system disorders | ||||
| Headache | 8 (2.0) | 14 (2.6) | 22 (2.4) | 0.7 |
| Dizziness | 2 (0.5) | 22 (4.1) | 24 (2.6) | < 0.0001 |
| Vertigo | 1 (0.3) | 0 (0) | 1 (0.1) | 0.4 |
| Muscle weakness | 5 (1.3) | 5 (0.9) | 10 (1.1) | 0.8 |
| Psychiatric disorders | ||||
| Anxiety | 9 (2.3) | 28 (5.3) | 37 (4) | 0.03 |
| Depression | 4 (1) | 7 (1.3) | 11 (1.2) | 0.8 |
| Insomnia | 8 (2.0) | 15 (2.8) | 23 (2.5) | 0.5 |
| Nervousness | 1 (0.3) | 6 (1.1) | 7 (0.8) | 0.1 |
| Stress | 17 (4.3) | 63 (11.8) | 80 (8.6) | < 0.0001 |
| Respiratory, thoracic, and mediastinal disorders | ||||
| Cough | 2 (0.5) | 4 (0.8) | 6 (0.6) | 0.8 |
| Hyposmia | 1 (0.3) | 0 (0) | 1 (0.1) | 0.4 |
| Sputum increased | 0 (0) | 2 (0.4) | 2 (0.2) | 0.5 |
| Renal and urinary disorders | ||||
| Polyuria | 1 (0.3) | 0 (0) | 1 (0.1) | 0.4 |
| Urinary incontinence | 1 (0.3) | 0 (0) | 1 (0.1) | 0.4 |
| Urinary retention | 1 (0.3) | 1 (0.3) | 2 (0.2) | 0.9 |
| Bladder spasm | 1 (0.3) | 2 (0.4) | 3 (0.3) | 0.7 |
| Skin and subcutaneous tissue disorders | ||||
| Stretch marks | 11 (2.8) | 27 (5.1) | 38 (4.1) | 0.09 |
| Total | 179 | 491 | 670 | 0.0001 |
Data expressed as the number of patients (%). Adverse events were classified according to the Medical Dictionary for Regulatory Activities Terminology. p-values were obtained with χ2.