Can Ofev Cause a Rash? Understanding Nintedanib-Related Skin Reactions

October 14, 2025 •

3 min read

While not frequently reported during the initial clinical trials, a skin rash has been identified as a possible side effect of the medication nintedanib, sold under the brand name Ofev, following its market approval. This raises the important question, "Can Ofev cause a rash?", which is a concern for many patients. This guide will provide crucial information on why a rash might occur and what steps you should take if you experience one.

Quick Summary

Ofev (nintedanib) may cause a skin rash, which is often a symptom of an allergic reaction. Though not a common finding in initial trials, post-market surveillance has confirmed its occurrence. Management of the rash involves reporting it to a doctor, who may recommend dose changes or stopping the medication depending on the severity.

Key Points

Ofev can cause a rash: A skin rash is a possible side effect of Ofev (nintedanib), often related to an allergic reaction.
Report rash to a doctor: Any rash, with or without itching, should be reported to your healthcare team for evaluation.
Allergic reactions vary: Rashes can be part of a mild allergic reaction or, rarely, a symptom of a severe, life-threatening anaphylactic reaction.
Post-market observation: The incidence of rash was reported more often after Ofev's approval than during its initial clinical trials.
Management involves medical guidance: Treatment for a rash may include symptomatic relief, dose adjustment, or stopping the medication under a doctor's supervision.
Emergency care for severe symptoms: Seek immediate medical help (call 911) if a rash is accompanied by swelling of the face, lips, or throat, or trouble breathing.

Can Ofev Cause a Rash? An Overview

Yes, it is possible for Ofev (nintedanib) to cause a skin rash, which is typically a sign of an allergic reaction. While the appearance of a rash was not a widely reported side effect during the medication's initial clinical studies, reports from patients after the drug became commercially available confirmed this potential reaction. A rash can present in different forms and can range in severity from mild to serious. It is crucial for patients to recognize the signs and know how to respond appropriately.

Recognizing and Responding to an Ofev-Related Rash

If you develop a rash while taking Ofev, you should immediately contact your doctor. A rash, with or without itching, may indicate an allergic reaction to the drug. Your healthcare team can help determine the cause and recommend the best course of action. They may suggest symptomatic treatment, dose modification, or even discontinuing the medication in severe cases.

Symptoms of a Mild Allergic Reaction

A mild allergic reaction involving the skin may include the following symptoms:

Skin rash
Itching
Flushing, which is a temporary redness or warmth of the skin

Symptoms of a Severe Allergic Reaction (Anaphylaxis)

In rare cases, a severe allergic reaction, known as anaphylaxis, can occur. This is a medical emergency and requires immediate attention. Call 911 or your local emergency number if you experience any of the following symptoms:

Trouble breathing or wheezing
Swelling of the face, lips, tongue, or throat
Racing heart
Fever or a general feeling of illness
Hives (pale red bumps on the skin)

Managing a Rash and Other Common Side Effects

Management of an Ofev-related rash depends on its severity. For a mild rash, a doctor may recommend over-the-counter treatments to manage symptoms. However, if the reaction is more severe or persistent, they may consider adjusting your Ofev dosage or temporarily interrupting treatment. In cases of a severe allergic reaction, immediate medical care is necessary, and you will likely need to switch to a different medication.

It is also important to note that Ofev can cause other gastrointestinal side effects that may impact medication absorption. If you experience vomiting or diarrhea, your doctor might need to adjust your dosage or recommend anti-diarrheal medication like loperamide. These symptoms, if severe, can also warrant a dose reduction or temporary pause in treatment.

Comparing Ofev's Common Side Effects


Side Effect	Severity	Commonality	Management
Skin Rash	Mild to Severe	Reported Post-market (Often allergic in nature)	Contact doctor; symptomatic treatment or dosage adjustment. Immediate medical care for severe symptoms.
Diarrhea	Mild to Moderate (often)	Very Common (up to 76% in some trials)	Hydration, anti-diarrheal medication (loperamide), dose reduction, or temporary interruption
Nausea	Mild to Moderate	Common (up to 32% in some trials)	Take Ofev with food, anti-nausea medication, dose reduction, or temporary interruption
Liver Problems	Rare but Serious	Less Common, but serious risk	Requires frequent blood tests to monitor liver function. Dose adjustment or discontinuation may be necessary
Bleeding	Rare but Serious	Less Common	Close monitoring for patients on anticoagulants. Discontinuation may be necessary

Conclusion: Recognizing and Responding to Ofev's Skin Reactions

In conclusion, Ofev can indeed cause a skin rash, most often as a manifestation of an allergic reaction. While initial trials did not highlight this effect, real-world experience has confirmed its possibility. Patients and caregivers should be vigilant for any skin changes, from a mild, itchy rash to the more severe, life-threatening symptoms of anaphylaxis. Promptly communicating with your healthcare provider is the most critical step. They can help distinguish between mild and serious reactions, manage symptoms effectively, and ensure that your treatment plan is both safe and effective. As with any medication, close monitoring and open communication with your medical team are the best strategies for managing potential side effects.

Ofev Patient Safety Information

Frequently Asked Questions

A rash was not commonly reported in Ofev's clinical trials, but its occurrence has been noted since the drug was approved for use. It is considered a possible side effect, often as a symptom of an allergic reaction.

You should contact your doctor right away if you develop a rash while taking Ofev. They will assess the severity and determine the best course of action, which could range from monitoring to adjusting your dose or stopping the medication.

Yes, while a rash can be mild, it can also be a sign of a severe allergic reaction (anaphylaxis). Symptoms like trouble breathing, swelling of the face, or hives require immediate medical attention.

A rash from Ofev is often, but not always, related to an allergic reaction. Your doctor can investigate other potential causes and rule out other issues.

Information regarding whether rash risk is tied to dosage is limited. However, a doctor may reduce your dosage if you experience persistent side effects, including a rash, to see if it resolves.

Whether you continue Ofev after a mild rash depends on your doctor's assessment. They will determine if symptomatic treatment is sufficient or if a change in your regimen is needed.

Other common side effects of Ofev include diarrhea, nausea, abdominal pain, vomiting, decreased appetite, and headache. Like with a rash, reporting and managing these symptoms with your doctor is important.