CYCLOPENTOLATE\PHENYLEPHRINE: 26 Adverse Event Reports & Safety Profile
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26
Total FAERS Reports
1 (3.8%)
Deaths Reported
2
Hospitalizations
26
As Primary/Secondary Suspect
2
Life-Threatening
Active Ingredient: CYCLOPENTOLATE HYDROCHLORIDE\PHENYLEPHRINE HYDROCHLORIDE ·
First Report: 20140814 · Latest Report: 20250304
What Are the Most Common CYCLOPENTOLATE\PHENYLEPHRINE Side Effects?
#1 Most Reported
Apnoea
12 reports (46.2%)
#2 Most Reported
Vomiting
8 reports (30.8%)
#3 Most Reported
Gastric residual increased
8 reports (30.8%)
All CYCLOPENTOLATE\PHENYLEPHRINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Apnoea | 12 | 46.2% | 0 | 0 |
| Abdominal distension | 8 | 30.8% | 0 | 0 |
| Feeding intolerance | 8 | 30.8% | 0 | 0 |
| Gastric residual increased | 8 | 30.8% | 0 | 0 |
| Vomiting | 8 | 30.8% | 0 | 0 |
Who Reports CYCLOPENTOLATE\PHENYLEPHRINE Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 12.0 years. Most reports from: US. View detailed demographics →
Is CYCLOPENTOLATE\PHENYLEPHRINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 2 | 0 | 0 |
| 2015 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2024 | 3 | 0 | 0 |
| 2025 | 1 | 0 | 0 |
What Is CYCLOPENTOLATE\PHENYLEPHRINE Used For?
| Indication | Reports |
|---|---|
| Retinopathy of prematurity | 10 |
| Mydriasis | 5 |
Official FDA Label for CYCLOPENTOLATE\PHENYLEPHRINE
Official prescribing information from the FDA-approved drug label.