Common Side Effects of Ofev (Nintedanib)
Diarrhea is the most common side effect of Ofev, occurring in approximately 62% of patients, followed by nausea, vomiting, and abdominal pain, with gastrointestinal adverse events being the predominant concern requiring proactive management. 1, 2
Gastrointestinal Side Effects
The gastrointestinal system bears the brunt of nintedanib's adverse effects:
- Diarrhea occurs in 62.4% of nintedanib-treated patients versus only 18.4% on placebo, making it the single most frequent adverse event 2
- Nausea is 3.1 times more frequent with nintedanib treatment compared to placebo 1
- Vomiting occurs 3.6 times more frequently with nintedanib 1
- Abdominal pain is 4.2 times more common in nintedanib-treated patients 1
Despite the high frequency of diarrhea, only 4.4% of patients permanently discontinue treatment due to this specific side effect, as it can be effectively managed with dose adjustments and anti-diarrheal medications 2, 3
Hepatic Side Effects
Liver enzyme elevations require systematic monitoring:
- AST elevation occurs 3.2 times more frequently with nintedanib 1
- ALT elevation is 3.6 times more common with nintedanib treatment 1
- Monthly liver function testing is recommended for the first 3 months, then every 3 months thereafter 1
- Elevations can typically be managed through dose reduction or temporary treatment interruption 2
Weight Loss and Nutritional Effects
- Weight loss occurs 3.7 times more frequently in nintedanib-treated patients compared to placebo 1
- This side effect warrants regular monitoring throughout treatment 1
Treatment Modifications Due to Adverse Events
The frequency of treatment adjustments reflects the impact of side effects:
- Dose reductions to 100 mg twice daily occur 7.9 times more frequently with nintedanib than placebo 1
- Treatment interruptions are needed in 23.7% of nintedanib patients versus 9.9% on placebo 2
- Permanent discontinuation due to adverse events occurs in 19.3% of nintedanib patients versus 13.0% on placebo, representing a 1.9-fold increase 1, 2
Less Common but Important Side Effects
While gastrointestinal and hepatic effects dominate, other adverse events include:
- Bleeding events are rarely reported but should be monitored 4
- Cardiovascular adverse events are infrequently observed 4
Clinical Management Pearls
Real-world experience confirms that the adverse event profile in clinical practice matches that seen in trials 5, 4. The key to successful treatment is:
- Patient education before starting therapy about expected gastrointestinal symptoms 5
- Proactive management with anti-diarrheal medications at the first sign of diarrhea 5, 2
- Dose reduction to 100 mg twice daily when the standard 150 mg twice daily dose is not tolerated, particularly for persistent gastrointestinal effects 6
- Regular monitoring of liver enzymes, weight, and gastrointestinal symptoms 1
The safety profile remains consistent across different fibrotic lung diseases, including idiopathic pulmonary fibrosis, systemic sclerosis-associated interstitial lung disease, and progressive pulmonary fibrosis 7, 1