What the label lists and what reports show
Pemetrexed side effects
Pemetrexed's FDA label: “The most common adverse reactions (incidence ≥20%) of pemetrexed, when administered as a single agent are fatigue, nausea, and anorexia.” FAERS holds 37,889 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 malignant neoplasm progression (3,095 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the pemetrexed FDA label on DailyMed (effective October 8, 2025, Avyxa Pharma, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of AXTLE?AXTLE can cause serious side effects, including: ● Low blood cell counts. Low blood cell counts can be severe, including low white blood cell counts (neutropenia), low platelet counts (thrombocytopenia), and low red blood cell counts (anemia). Your healthcare provider will do blood tests to check your blood cell counts regularly during your treatment with AXTLE. Tell your healthcare provider right away if you have any signs of infection, fever, bleeding, or severe tiredness during your treatment with AXTLE. ● Kidney problems, including kidney failure. AXTLE can cause severe kidney problems that can lead to death. Severe vomiting or diarrhea can lead to loss of fluids (dehydration) which may cause kidney problems to become worse. Tell your healthcare provider right away if you have a decrease in amount of urine. ● Severe skin reactions. […]
Source: FDA drug label, Avyxa Pharma, LLC, effective October 8, 2025 (SPL set 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥20%) of pemetrexed, when administered as a single agent are fatigue, nausea, and anorexia.
Table 8: Adverse Reactions Occurring in ≥5% of Fully Supplemented Subgroup of Patients Receiving Pemetrexed/Cisplatin in Study JMCH a
| Reaction | All Grades (%) | Grade 3-4 (%) | All Grades (%) | Grade 3-4 (%) |
|---|---|---|---|---|
| Neutropenia | 56 | 23 | 13 | 3 |
| Anemia | 26 | 4 | 10 | 0 |
| Thrombocytopenia | 23 | 5 | 9 | 0 |
| Elevated creatinine | 11 | 1 | 10 | 1 |
| Decreased creatinine clearance | 16 | 1 | 18 | 2 |
| Conjunctivitis | 5 | 0 | 1 | 0 |
| Nausea | 82 | 12 | 77 | 6 |
| Vomiting | 57 | 11 | 50 | 4 |
| Stomatitis/pharyngitis | 23 | 3 | 6 | 0 |
| Anorexia | 20 | 1 | 14 | 1 |
| Diarrhea | 17 | 4 | 8 | 0 |
| Constipation | 12 | 1 | 7 | 1 |
| Dyspepsia | 5 | 1 | 1 | 0 |
| Fatigue | 48 | 10 | 42 | 9 |
| Dehydration | 7 | 4 | 1 | 1 |
| Sensory neuropathy | 10 | 0 | 10 | 1 |
| Taste disturbance | 8 | 0 | 6 | 0 |
| Rash | 16 | 1 | 5 | 0 |
| Alopecia | 11 | 0 | 6 | 0 |
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 adverse reactions are discussed in greater detail in other sections of the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Renal failure [see Warnings and Precautions (5.2) ] Bullous and exfoliative skin toxicity [see Warnings and Precautions (5.3) ] Interstitial pneumonitis [see Warnings and Precautions (5.4) ] Radiation recall [see Warnings and Precautions (5.5) ] The most common adverse reactions (incidence ≥20%) of pemetrexed, when administered as a single agent are fatigue, nausea, and anorexia. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed when administered with cisplatin are vomiting, neutropenia, anemia, stomatitis/pharyngitis, thrombocytopenia, and constipation. ( 6.1 ) The most common adverse reactions (incidence ≥20%) of pemetrexed when administered in combination with pembrolizumab and platinum chemotherapy are fatigue/asthenia, nausea, constipation, diarrhea, decreased appetite, rash, vomiting, cough, dyspnea, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avyxa Pharma, LLC at 1-888-520-0954 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 reactions rates cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. …
Source: FDA drug label, Avyxa Pharma, LLC, effective October 8, 2025 (SPL set 9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1), via openFDA; the full label on DailyMed
What do FAERS reports show?
37,889 reports list pemetrexed among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,188 are coded as a death and 17,979 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 21 reactions below, 16 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?
- Pemetrexed: 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