Nalex-DH Side Effects

Generic name: hydrocodone / phenylephrine

Note: This document provides detailed information about Nalex-DH Side Effects associated with hydrocodone / phenylephrine. Some dosage forms listed on this page may not apply specifically to the brand name Nalex-DH.

Applies to hydrocodone/phenylephrine: oral liquid, oral syrup.

Important warnings This medicine can cause some serious health issues

Use caution when driving, operating machinery, or performing other hazardous activities.

Hydrocodone and phenylephrine may cause dizziness or drowsiness.

If you experience dizziness or drowsiness, avoid these activities.

Use alcohol cautiously.

Alcohol may increase drowsiness and dizziness while taking hydrocodone and phenylephrine.

Hydrocodone and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants.

Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

Hydrocodone is habit forming.

It is possible become physically and/or psychologically dependent on the medication.

Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor.

Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use.

Your doctor may recommend a gradual reduction in dose.

If you experience any of the following serious side effects, stop taking hydrocodone and phenylephrine and seek emergency medical attention or contact your doctor immediately:

• a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

• confusion, hallucinations, or unusual behavior.

Other, less serious side effects may be more likely to occur. Continue to take hydrocodone and phenylephrine and talk to your doctor if you experience

• dizziness, drowsiness, or sleepiness;

• restlessness or irritability;

• blurred vision;

• constipation;

• dry mouth;

• nausea, vomiting, or decreased appetite;

• muscle twitches;

• sweating;

• itching; or

• decreased urination.

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if hydrocodone and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to hydrocodone / phenylephrine: oral liquid, oral syrup.

General

The most common adverse events were occasional drowsiness, dry mouth, blurred vision, dizziness, mild mental stimulation, and gastric irritation.^[Ref]

Nervous system

• Rare (less than 0.1%): Occasional drowsiness, dizziness, mild mental stimulation
• Postmarketing reports: Convulsions^[Ref]

Respiratory

• Postmarketing reports: Breathing difficulties^[Ref]

Genitourinary

• Postmarketing reports: Urinary retention, androgen deficiency^[Ref]

Androgen deficiency:

Chronic opioid use may affect the hypothalamic-pituitary-gonadal axis leading to androgen deficiency.

Symptoms may include low libido, impotence, erectile dysfunction, amenorrhea, and infertility.

Opioids role in androgen deficiency have not been evaluated where other factors (medical, physical, lifestyle, psychological) have been adequately controlled.

Perform laboratory evaluation for symptoms of androgen deficiency.^[Ref]

Psychiatric

• Rare (less than 0.1%): Mild mental stimulation
• Postmarketing reports: Hallucinations^[Ref]

Cardiovascular

• Postmarketing reports: Rapid heart rate, reflex bradycardia^[Ref]

Ocular

• Rare (less than 0.1%): Blurred vision^[Ref]

Hypersensitivity

• Postmarketing reports: Allergic reaction^[Ref]

Gastrointestinal

• Rare (less than 0.1%): Dry mouth, gastric irritation^[Ref]

Further information

Nalex-DH side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer