What the label lists and what reports show
Pilocarpine side effects
Pilocarpine's FDA label: “In the 2 placebo-controlled studies, the most common adverse events related to drug use were sweating, urinary frequency, chills, and vasodilatation (flushing).” FAERS holds 2,463 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 headache (199 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the pilocarpine FDA label on DailyMed (effective December 5, 2024, Advanz Pharma (US) Corp.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsIn the 2 placebo-controlled studies, the most common adverse events related to drug use were sweating, urinary frequency, chills, and vasodilatation (flushing).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Event Headache | Pilocarpine HCl 5 mg q.i.d. (20 mg/day) N = 255/13% | Placebo (q.i.d.) N = 253/19% |
|---|---|---|
| Flu Syndrome | 9 | 9 |
| Dyspepsia | 7 | 7 |
| Dizziness | 6 | 7 |
| Pain | 4 | 2 |
| Sinusitis | 4 | 5 |
| Abdominal Pain | 3 | 4 |
| Vomiting | 3 | 1 |
| Pharyngitis | 2 | 5 |
| Rash | 2 | 3 |
| Infection | 2 | 6 |
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, continuedHead & Neck Cancer Patients: In controlled studies, 217 patients received pilocarpine, of whom 68% were men and 32% were women. Race distribution was 91% Caucasian, 8% Black, and 1% of other origin. Mean age was approximately 58 years. The majority of patients were between 50 and 64 years (51%), 33% were 65 years and older and 16% were younger than 50 years of age. The most frequent adverse experiences associated with SALAGEN ® Tablets were a consequence of the expected pharmacologic effects of pilocarpine. Adverse Event Pilocarpine HCl Placebo 10 mg t.i.d. (30 mg/day) 5 mg t.i.d. (15 mg/day) (t.i.d.) Sweating N = 121/68% N = 141/29% N = 152/9% Nausea 15 6 4 Rhinitis 14 5 7 Diarrhea 7 4 5 Chills 15 3 <1 Flushing 13 8 3 Urinary Frequency 12 9 7 Dizziness 12 5 4 Asthenia 12 6 3 In addition, the following adverse events (≥3% incidence) were reported at dosages of 15-30 mg/day in the controlled clinical trials: Adverse Event Pilocarpine HCl Placebo 5-10 mg t.i.d. …
Source: FDA drug label, Advanz Pharma (US) Corp., effective December 5, 2024 (SPL set 62eda83d-d043-4c7e-8fcf-75d05efbf35b), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,463 reports list pilocarpine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 98 are coded as a death and 677 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 22 reactions below, 14 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?
- Pilocarpine: 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