Systemic adverse events among RCT.
| Treatment Group/Drug Administration (range, %) | ||||
|---|---|---|---|---|
| Adverse Effects | Topical | PO | Vehicle* | Placebo |
| Upper GI NOS8 | 10.3 | 8.5 | – | – |
| GI NOS8,11 | 2.6–4.8 | 0.8–13.4 | – | 7.3 |
| Abdominal pain | 1.4–12 | 3–22 | 0.9–3.1 | 0.6–2.4 |
| Dyspepsia | 0.7–15 | 3–26 | 0.9–5 | 0.8–6 |
| Gastritis | 0.9–2.2 | 0 | 0 | 0–2.4 |
| Nausea | 0–8 | 2–13 | 0.6–5.6 | 0 |
| Diarrhea | 0–9 | 1.5–17 | 0–2 | 0–4 |
| Constipation | 0.9–8 | 0–10 | 0.6–1 | 1 |
| GI bleed** | 0–1 | 0–2 | 0–1.2 | 0 |
| Halitosis | 0–5 | 0.3 | 0–1.2 | 0 |
| Liver function abnormality | 0–6.9 | 7.9–19.6 | 1.3–5.3 | 0.6–4.2 |
| Renal abnormality† | 0–7.6 | 7.2–10 | 6 | 0–5.7 |
| Change in hemoglobin | 0–2.1 | 5.8–10 | 3.3 | 4.9 |
| Respiratory disorder†† | 0–3.2 | 2–5.3 | 0.5–2.5 | 3.8 |
| CNS NOS8,11 | 6–9.5 | 6.8–7.3 | – | 4.9 |
| Dizziness | 0.6–1.2 | 4 | 0 | – |
| Vertigo | 0–1 | – | – | – |
| Headache | 5–17.5 | 6–17.2 | 4.3–13 | 11.5 |
↵* Vehicle contains DMSO, pluronic lecithin organogel base, or isopropyl alcohol, propylene glycol, cocoyl caprylocaprate, mineral oil, ammonia solution, perfume cream 45/3, carbomer 980, polyoxyl 20 cetostearyl ether, and purified water.
↵** GI bleed includes melena and rectal hemorrhage.
↵† Percentage of patients changing from normal to abnormal creatinine clearance (ml/min).
↵†† Respiratory disorder includes asthma, cough, and dyspnea. GI: gastrointestinal; NOS: not otherwise specified; CNS: central nervous system.