Artiss Side Effects Center

Last updated on RxList: 11/9/2022
Artiss Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Artiss?

Artiss [fibrin sealant (human)] is indicated to adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations greater than or equal to 1 year of age.

What Are Side Effects of Artiss?

Artiss may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • itching,
  • warmth,
  • redness,
  • numbness,
  • tingly feeling,
  • nausea,
  • vomiting,
  • lightheadedness,
  • fast or slow heartbeats,
  • wheezing,
  • chest tightness,
  • chest pain,
  • cough,
  • gasping for breath,
  • confusion,
  • agitation,
  • panic,
  • extreme fear,
  • sudden numbness or weakness (especially on one side of the body),
  • sudden severe headache,
  • slurred speech,
  • problems with vision or balance,
  • blue-colored appearance of your skin or lips,
  • dizziness,
  • spinning sensation, and
  • redness, itching, irritation, or slow healing of the skin wound or treated area

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Artiss include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Artiss

Apply Artiss as a thin layer using the Easyspray and Spray Set A 2 mL dose will cover approximately 100 cm surface area.

What Drugs, Substances, or Supplements Interact with Artiss?

Artiss may interact with other drugs. Tell your doctor all medications and supplements you use.

Artiss During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Artiss; it is unknown how it would affect a fetus. It is unknown if Artiss passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Artiss [fibrin sealant (human)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


Emotional trauma is best described as a psychological response to a deeply distressing or life-threatening experience. See Answer
Artiss Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives, itching, warmth, redness, numbness, tingly feeling; nausea, vomiting, feeling light-headed, fast or slow heartbeats; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.

Fibrin sealant is sometimes applied with a spray device that uses gas pressure. High pressure may cause the release of air or gas under the skin tissues, where it can then travel throughout the body. This may be more likely when high pressure settings are improperly used by a healthcare provider during the spray application of fibrin sealant. Air or gas trapped within the body can cause serious or life-threatening effects. Talk with your doctor about this risk.

Tell your caregivers at once if you have:

  • chest pain, cough, trouble breathing, gasping for breath;
  • confusion, agitation, panic, extreme fear;
  • sudden numbness or weakness (especially on one side of the body);
  • sudden severe headache, slurred speech, problems with vision or balance;
  • blue-colored appearance of your skin or lips;
  • nausea, dizziness or spinning sensation;
  • a light-headed feeling, like you might pass out; or
  • redness, itching, irritation, or slow healing of the skin wound or treated area;

Common side effects may include:

  • itching; or
  • swelling or bruising.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


8 First Aid Kit Essentials for Scrapes, Cuts, Bug Bites, and More See Slideshow
Artiss Professional Information


Overall Adverse Reactions

Adverse reactions occurring in greater than 1% of patients treated with ARTISS were skin graft failure and pruritus.

Hypersensitivity/Allergic/Anaphylactic Reactions

Hypersensitivity or allergic/anaphylactoid reactions may occur (see WARNINGS AND PRECAUTIONS, Hypersensitivity/Allergic/Anaphylactic Reactions). No adverse events of this type were reported during clinical trials.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The following adverse reactions have been reported from a clinical trial where ARTISS was used to affix split thickness sheet skin grafts to excised burn wounds (see Clinical Studies). A total of 8 non-serious adverse reactions were deemed related to the use of ARTISS by the investigator. Of the 8 related non-serious adverse reactions, 5 were incidences of skin graft failure: 4 were graft detachment/non-adherence and 1 was graft necrosis. The graft detachment in 2 patients may have been related to the maximum thawing temperature (40°C) being exceeded during study product preparation. The 3 other non-serious adverse reactions considered related to ARTISS were 2 incidences of pruritus and 1 incidence of dermal cyst. The graft necrosis and the 2 cases of pruritus considered related to ARTISS each had an equivalent adverse reaction with the exact start date and severity reported at a control wound where skin grafts were affixed with staples. Therefore, these events are most likely not related to ARTISS, but instead are expected outcomes for any grafted wound regardless of the method of attachment.

Overall, the data collected and analyzed during this study demonstrated that ARTISS is safe for the attachment of sheet skin grafts in subjects with deep partial thickness or full thickness burn wounds.

The adverse reactions and their frequencies are summarized in Table 2:

Table 2.

Adverse reactions (Preferred Term) Number of events /
Number of patients treated
Dermal cyst 1/138
Pruritus 2/138
Skin graft failure 5/138

Post Marketing

The following adverse reactions reflect what has been reported in post marketing experience with Baxter's fibrin sealant that could reasonably be expected to occur with ARTISS:

Immune system disorders: anaphylactic responses, hypersensitivity
Cardiac disorders: bradycardia, tachycardia
Respiratory, thoracic and mediastinal disorders: dyspnea
Gastrointestinal disorders: nausea
Skin and subcutaneous tissue disorders: urticaria
General disorders and administration site conditions: flushing, impaired healing, edema, pyrexia
Injury, poisoning and procedural complication: seroma

Air embolism associated with misapplication of fibrin sealant using the spray device, Class Effect: A postmarketing fatality was reported in association with the use of another fibrin sealant when applied using a spray device. The case involved an attempt to stop active bleeding by applying the fibrin sealant using a spray device attached to a wall unit at a higher than recommended pressure for the spray device. In addition, the spray head was placed at a distance from the bleeding site that was closer than the recommended distance guidelines for the application of the sealant. The patient suffered a fatal air embolism.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

Read the entire FDA prescribing information for Artiss (Fibrin Sealant (Human)] Frozen Solution)

© Artiss Patient Information is supplied by Cerner Multum, Inc. and Artiss Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors