What the label lists and what reports show
Elexacaftor and ivacaftor and tezacaftor side effects
Elexacaftor and ivacaftor and tezacaftor's FDA label: “The most common adverse drug reactions to TRIKAFTA (≥5% of patients and at a frequency higher than placebo by ≥1%) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood …” FAERS holds 12,399 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is infective pulmonary exacerbation of cystic fibrosis (812 reports).
- No generic listed
- Boxed warning
Check it at the source: the elexacaftor and ivacaftor and tezacaftor FDA label on DailyMed (effective June 22, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible or reasonably likely side effects of TRIKAFTA?TRIKAFTA can cause serious side effects, including: See " What is the most important information I should know about TRIKAFTA? " Serious Allergic Reactions can happen to people who are treated with TRIKAFTA. Call your healthcare provider or go to the emergency room right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction may include: rash or hives tightness of the chest or throat or difficulty breathing swelling of the face, lips and/or tongue, difficulty swallowing light-headedness or dizziness Increased pressure around the brain (intracranial hypertension) has happened in people treated with TRIKAFTA. If you experience an unusual headache, blurred vision, double vision, or vision loss, call your healthcare provider right away. […]
Source: FDA drug label, Vertex Pharmaceuticals Incorporated, effective June 22, 2026 (SPL set f354423a-85c2-41c3-a9db-0f3aee135d8d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse drug reactions to TRIKAFTA (≥5% of patients and at a frequency higher than placebo by ≥1%) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, blood bilirubin increased and constipation.
Table 4: Adverse Reactions Occurring in ≥5% of TRIKAFTA-Treated Patients and Higher than Placebo by ≥1% in Trial 1
| Adverse Reactions | TRIKAFTA N=202 n (%) | Placebo N=201 n (%) |
|---|---|---|
| Headache | 35 (17) | 30 (15) |
| Upper respiratory tract infection Includes upper respiratory tract infection and viral… | 32 (16) | 25 (12) |
| Abdominal pain Includes abdominal pain, abdominal pain upper, abdominal pain lower. | 29 (14) | 18 (9) |
| Diarrhea | 26 (13) | 14 (7) |
| Rash Includes rash, rash generalized, rash erythematous, rash macular, rash pruritic. | 21 (10) | 10 (5) |
| Alanine aminotransferase increased | 20 (10) | 7 (3) |
| Nasal congestion | 19 (9) | 15 (7) |
| Blood creatine phosphokinase increased | 19 (9) | 9 (4) |
| Aspartate aminotransferase increased | 19 (9) | 4 (2) |
| Rhinorrhea | 17 (8) | 6 (3) |
| Rhinitis | 15 (7) | 11 (5) |
| Influenza | 14 (7) | 3 (1) |
| Sinusitis | 11 (5) | 8 (4) |
| Blood bilirubin increased | 10 (5) | 2 (1) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Drug-Induced Liver Injury and Liver Failure [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions, Including Anaphylaxis [see Warnings and Precautions (5.2) ] Intracranial Hypertension [see Warnings and Precautions (5.3) ] Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.4) ] Cataracts [see Warnings and Precautions (5.7) ] The most common adverse drug reactions to TRIKAFTA (≥5% of patients and at a frequency higher than placebo by ≥1%) were headache, upper respiratory tract infection, abdominal pain, diarrhea, rash, alanine aminotransferase increased, nasal congestion, blood creatine phosphokinase increased, aspartate aminotransferase increased, rhinorrhea, rhinitis, influenza, sinusitis, blood bilirubin increased and constipation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vertex Pharmaceuticals Incorporated at 1-877-634-8789 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 clinical practice.
Source: FDA drug label, Vertex Pharmaceuticals Incorporated, effective June 22, 2026 (SPL set f354423a-85c2-41c3-a9db-0f3aee135d8d), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,399 reports list elexacaftor and ivacaftor and tezacaftor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 241 are coded as a death and 3,411 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2020 (5,170, against a median of 1,050 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Elexacaftor and ivacaftor and tezacaftor: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions