Ixekizumab Side Effects
Applies to ixekizumab: subcutaneous solution.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause you to get infections more easily (eg, eye, mouth, skin, or upper respiratory tract infections). It is important to check with your doctor if you or your child have fever or chills, cough or hoarseness, runny or stuffy nose, pain, redness, swelling, dryness, or itching of the eyes, skin itching or scaling, sores or white patches on your lips, mouth, or throat, lower back or side pain, or painful or difficult urination.
You will need to have a skin test for tuberculosis before you or your child starts using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis test or been exposed to tuberculosis.
This medicine may cause serious allergic reactions, including angioedema. This may be life-threatening and require immediate medical attention. Tell your doctor if you or your child have a rash, itching, or large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs.
While you are being treated with ixekizumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. You should receive all your vaccines before starting treatment with this medicine. Ixekizumab may lower your body's resistance and the vaccine may not work as well, or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
Inflammatory bowel disease may occur or worsen while you are using this medicine. Tell your doctor right away if you or your child have rectal bleeding, severe abdominal or stomach pain, or severe diarrhea while using this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of ixekizumab
Along with its needed effects, ixekizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking ixekizumab:
More common side effects
- body aches or pain
- burning, dry, or itching eyes
- chills
- cough
- difficulty with breathing
- discharge or excessive tearing
- ear congestion
- fever
- headache
- hoarseness
- itching in the genital or other skin areas
- loss of voice
- lower back or side pain
- painful or difficult urination
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- runny or stuffy nose
- scaling of the skin
- sneezing
- sore mouth or tongue
- sore throat
- unusual tiredness or weakness
- white patches in the mouth or on the tongue
Less common side effects
- chest tightness
- diarrhea
- difficulty swallowing
- dizziness
- fast heartbeat
- general feeling of discomfort or illness
- hives, itching, skin rash
- joint pain
- loss of appetite
- muscle aches and pains
- nausea
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shivering
- sweating
- trouble sleeping
- vomiting
Rare side effects
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- rectal bleeding
- redness of the skin
- severe diarrhea
- severe stomach pain
Other side effects of ixekizumab
Some side effects of ixekizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
For healthcare professionals
Applies to ixekizumab: subcutaneous solution.
General adverse events
Most commonly reported adverse reactions with a frequency of 1% or greater were injection site reactions, upper respiratory tract infections, nausea, and tinea infections.
Cardiovascular
- Common (1% to 10%): Hypertension
Dermatologic
- Common (1% to 10%): Urticaria, herpes simplex (mucocutaneous)
- Uncommon (0.1% to 1%): Angioedema, cellulitis, rash, eczema, pruritus, alopecia[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, diarrhea, oral herpes, pharyngitis, oropharyngeal pain
- Uncommon (0.1% to 1%): Oral candidiasis, inflammatory bowel disease, abdominal pain
- Rare (0.01% to 0.1%): Oesophageal candidiasis
- Frequency not reported: Crohn's disease, ulcerative colitis, gastroenteritis[Ref]
Genitourinary
- Common (1% to 10%): Vulvovaginal candidiasis, menstrual disorder, irregular menstruation, uterine dilation, curettage
- Uncommon (0.1% to 1%): Ovarian cyst
- Frequency not reported: Bacterial vaginosis, bartholinitis
Hematologic
- Very common (10% or more): Neutropenia (Up to 11%)
- Common (1% to 10%): Thrombocytopenia, anemia[Ref]
Hypersensitivity
- Frequency not reported: Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria)[Ref]
Immunologic
- Very common (10% or more): Infections ( Up to 27%), immunogenicity (Up to 22%)
- Common (1% to 10%): Tinea infections, influenza
- Uncommon (0.1% to 1%): Serious infections[Ref]
Local
- Very common (10% or more): Injection site reactions (Up to 17%)
- Frequency not reported: Erythema, pain
- Postmarketing reports: Esophageal candidiasis[Ref]
Musculoskeletal
- Common (1% to 10%): Arthralgia, back pain, myalgia
- Uncommon (0.1% to 1%): Musculoskeletal pain, neck pain, non-cardiac chest pain
Nervous system
- Uncommon (0.1% to 1%): Headache, dizziness
Ocular
- Common (1% to 10%): Conjunctivitis
- Uncommon (0.1% to 1%): Iridocyclitis, eye pain[Ref]
Other
- Common (1% to 10%): Anti-drug antibodies development
- Uncommon (0.1% to 1%): Fatigue, pyrexia
Psychiatric
- Common (1% to 10%): Depression
Respiratory
- Very common (10% or more): Upper respiratory tract infections (including nasopharyngitis and rhinovirus infection) (Up to 16%)
- Uncommon (0.1% to 1%): Rhinitis, bronchitis, sinusitis[Ref]
Metabolic
- Uncommon (0.1% to 1%): Increased blood creatine phosphokinase, increased aspartate aminotransferase
Renal
- Common (1% to 10%): Dysuria
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2016) "Product Information. Taltz Autoinjector (ixekizumab)." Eli Lilly and Company
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Further information
Ixekizumab side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.