What are the possible side effects of Phenylephrine Hydrochloride?
Get emergency medical help if you have any of these signs of an allergic reaction to Phenylephrine Hydrochloride: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Phenylephrine Hydrochloride and call your doctor at once if you have:
-
fast, pounding, or uneven heartbeat;
-
severe dizziness or anxiety;
-
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
-
dangerously high blood pressure (severe headache, blurred vision, ringing in your ears, anxiety, confusion, chest pain, trouble breathing, uneven heart rate, seizure).
Common Phenylephrine Hydrochloride side effects may include:
-
loss of appetite;
-
warmth, tingling, or redness under your skin;
-
feeling restless or excited (especially in children);
-
sleep problems (insomnia); or
-
skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Phenylephrine Hydrochloride in details
The following serious adverse reactions are described below and elsewhere in the labeling:
- Cardiovascular Effects
- Elevation in Blood Pressure
The following adverse reactions have been identified following use of Phenylephrine Hydrochloride ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Ocular Adverse Reactions
Eye pain and stinging on instillation, temporary blurred vision and photophobia, and conjunctival sensitization may occur.
Systemic Adverse Reactions
A marked increase in blood pressure has been reported particularly, but not limited to low weight premature neonates, infants and hypertensive patients.
Cardiovascular effects which have been seen primarily in hypertensive patients following topical ocular use of Phenylephrine Hydrochloride ophthalmic solution 10% include marked increase in blood pressure, syncope, myocardial infarction, tachycardia, arrhythmia and subarachnoid hemorrhage.
What is the most important information I should know about Phenylephrine Hydrochloride?
- Phenylephrine Hydrochloride may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Phenylephrine Hydrochloride. Using Phenylephrine Hydrochloride alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
- If your symptoms do not improve within 7 days or if you develop a high fever, check with your doctor.
- If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Phenylephrine Hydrochloride.
- Do not take diet or appetite control medicines while you are taking Phenylephrine Hydrochloride.
- Phenylketonuria patients - Phenylephrine Hydrochloride may contain phenylalanine.
- Diabetes patients - Phenylephrine Hydrochloride may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
- Use Phenylephrine Hydrochloride with caution in the ELDERLY because they may be more sensitive to its effects.
- Use Phenylephrine Hydrochloride with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Phenylephrine Hydrochloride during pregnancy. It is unknown if Phenylephrine Hydrochloride is excreted in breast milk. If you are or will be breast-feeding while you are using Phenylephrine Hydrochloride, check with your doctor or pharmacist to discuss the risks to your baby.
When used for long periods of time or at high doses, some people develop a need to continue taking Phenylephrine Hydrochloride. This is known as DEPENDENCE or addiction. If you are addicted and suddenly stop taking Phenylephrine Hydrochloride, you may experience WITHDRAWAL symptoms, including depression.
Phenylephrine Hydrochloride contraindications
Cardiac and Endocrine Disease
Phenylephrine Hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. Phenylephrine Hydrochloride ophthalmic solution 2.5% should be used in these patients.
Pediatric Patients Less Than 1 Year of Age
Phenylephrine Hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. Phenylephrine Hydrochloride ophthalmic solution 2.5% should be used in these patients.
References
- European Chemicals Agency - ECHA. "Phenylephrine: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "PHENYLEPHRINE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
- NCIt. "Phenylephrine: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Phenylephrine Hydrochloride are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Phenylephrine Hydrochloride. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
