What the label lists and what reports show
Pivmecillinam side effects
Pivmecillinam's FDA label: “The most common adverse reactions observed in ≥2% of the patients receiving PIVYA in clinical trials are nausea and diarrhea.” FAERS holds 188 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 malaise (20 reports).
- No generic listed
Check it at the source: the pivmecillinam FDA label on DailyMed (effective October 10, 2025, Alembic Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions observed in ≥2% of the patients receiving PIVYA in clinical trials are nausea and diarrhea.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions (AR) | PIVYA* N=282 n (%) | Placebo N=288 n (%) |
|---|---|---|
| Nausea | 12 (4.3) | 6 (2.1) |
| Diarrhea | 6 (2.1) | 2 (0.7) |
| Vulvovaginal candidiasis | 5 (1.8) | 0 |
| Genital pruritus | 5 (1.8) | 4 (1.4) |
| Headache | 4 (1.4) | 1 (0.3) |
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, continuedADVERSE REACTIONS The following clinically significant adverse reactions are described in greater detail in the Warnings and Precautions section of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Carnitine Depletion [see Warnings and Precautions ( 5.3 )] Acute Porphyria [see Warnings and Precautions ( 5.4 )] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.5 )] The most common adverse reactions observed in ≥2% of the patients receiving PIVYA in clinical trials are nausea and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Therapeutics at 1-866-210-9797 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 practice. The safety of PIVYA was evaluated in 579 adult female patients with uUTI who received PIVYA at a dose of 185 mg three times daily, or at higher daily doses (not approved for PIVYA) for 3 to 10 days in a placebo controlled trial (Trial 1, N=282), an active controlled trial (Trial 2, N=213) and an open label trial (Trial 3, N=84). …
Source: FDA drug label, Alembic Pharmaceuticals Inc., effective October 10, 2025 (SPL set 440a5f17-ab11-0fc8-e063-6394a90a58e9), via openFDA; the full label on DailyMed
What do FAERS reports show?
188 reports list pivmecillinam among the medicines taken, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 84 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 24 reactions below, 5 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.
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?
- Pivmecillinam: 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