What the label lists and what reports show
Deutivacaftor and tezacaftor and vanzacaftor side effects
Deutivacaftor and tezacaftor and vanzacaftor's FDA label: “Most common adverse reactions to ALYFTREK (≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1%) were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST …” FAERS holds 666 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 rash (43 reports).
- No generic listed
- Boxed warning
Check it at the source: the deutivacaftor and tezacaftor and vanzacaftor FDA label on DailyMed (effective August 26, 2026, Vertex Pharmaceuticals Incorporated); 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 ALYFTREK?ALYFTREK can cause serious side effects, including: See " What is the most important information I should know about ALYFTREK? " Serious Allergic Reactions can happen to people who are treated with ALYFTREK. 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 light-headedness or dizziness Increased pressure around the brain (intracranial hypertension) has happened in people treated with medicines containing the same or similar ingredients as ALYFTREK. 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 August 26, 2026 (SPL set 7e635909-c6fd-4f0d-ae77-cdff03653a20), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions to ALYFTREK (≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1%) were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST, and sinus congestion.
Table 3: Adverse Reactions Occurring in ≥5% of ALYFTREK-Treated Patients and ≥1% Higher than ELX/TEZ/IVA-Treated Patients Aged 12 Years and Older with CF Who Had at Least One F508del Variant or Responsive Variant in the…
| Adverse Reactions | ALYFTREK N=480 | ELX/TEZ/IVA N=491 |
|---|---|---|
| Cough Cough is composed of several similar terms including productive cough. | 120 (25%) | 116 (24%) |
| Nasopharyngitis | 102 (21%) | 95 (19%) |
| Upper respiratory tract infection Upper respiratory tract infection is composed of… | 101 (21%) | 97 (20%) |
| Headache | 76 (16%) | 63 (13%) |
| Oropharyngeal pain | 69 (14%) | 60 (12%) |
| Influenza | 52 (11%) | 26 (5%) |
| Fatigue | 51 (11%) | 46 (9%) |
| ALT increased | 38 (8%) | 29 (6%) |
| Rash | 37 (8%) | 22 (4%) |
| AST increased | 33 (7%) | 27 (5%) |
| Sinus congestion | 32 (7%) | 15 (3%) |
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) ] Patients Who Discontinued or Interrupted Elexacaftor-, Tezacaftor-, or Ivacaftor-Containing Drugs Due to Adverse Reactions [see Warnings and Precautions (5.3) ] Intracranial Hypertension [see Warnings and Precautions (5.4) ] Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.5) ] Cataracts [see Warnings and Precautions (5.8) ] Most common adverse reactions to ALYFTREK (≥5% of patients and at a frequency higher than ELX/TEZ/IVA by ≥1%) were cough, nasopharyngitis, upper respiratory tract infection, headache, oropharyngeal pain, influenza, fatigue, increased ALT, rash, increased AST, and sinus congestion. ( 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. …
Source: FDA drug label, Vertex Pharmaceuticals Incorporated, effective August 26, 2026 (SPL set 7e635909-c6fd-4f0d-ae77-cdff03653a20), via openFDA; the full label on DailyMed
What do FAERS reports show?
666 reports list deutivacaftor and tezacaftor and vanzacaftor among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 162 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. Of the 23 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?
- Deutivacaftor and tezacaftor and vanzacaftor: 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