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Promethazine is a phenothiazine derivative that acts as a potent H1-receptor antagonist. It also possesses significant anticholinergic (muscarinic), antidopaminergic, and alpha-adrenergic blocking activity. Its antiemetic effects are thought to be due to its anticholinergic and central nervous system depressant effects, including antagonism of D2 dopamine receptors in the chemoreceptor trigger zone (CTZ). Its sedative effects are due to its H1-blocking and anticholinergic properties.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Abnormal heartbeat (fast or slow)
Trouble controlling body movements, twitching, changes in balance, or difficulty swallowing or speaking
Shakiness, trouble moving around, or stiffness
Feeling confused
Feeling nervous and excitable
Hallucinations (seeing or hearing things that are not there)
Mood changes
Ringing in the ears
Seizures
Unexplained bruising or bleeding
Yellow skin or eyes
Changes in eyesight
Neuroleptic malignant syndrome (NMS), a potentially life-threatening condition, which may cause:
+ Fever
+ Muscle cramps or stiffness
+ Dizziness
+ Severe headache
+ Confusion
+ Changes in thinking
+ Fast heartbeat
+ Abnormal heartbeat
+ Excessive sweating
Severe breathing problems, including:
+ Slow, shallow, or troubled breathing
Low white blood cell counts, which may increase the risk of infection, and may cause:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Most people experience either no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical attention:

Dizziness
Drowsiness
Fatigue
Weakness
Blurred vision
Dry mouth
Upset stomach or vomiting
Trouble sleeping
Stuffy nose

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have respiratory conditions, including asthma, chronic obstructive pulmonary disease (COPD), or sleep apnea, which involves breathing difficulties during sleep.
* If you have liver problems or a history of Reye's syndrome, a rare but serious condition.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication in combination with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in any activity that requires alertness and clear vision, wait until you understand how this medication affects you.

This medication may interfere with the accuracy of certain pregnancy tests. If you are pregnant or suspect you may be pregnant, consult your doctor.

If you have diabetes, it is crucial to closely monitor your blood sugar levels while taking this medication.

Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.

You may be more susceptible to sunburn while taking this medication. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds. Use protective measures such as sunscreen, clothing, and eyewear that provide adequate protection against the sun.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Consult your doctor to determine if you are at a higher risk of experiencing seizures while taking this medication.

If you are 65 years or older, exercise caution when taking this medication, as you may be more prone to experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby.

• MAO inhibitors (concurrent use or within 14 days of promethazine)
• Other phenothiazines (increased risk of extrapyramidal symptoms)

• CNS depressants (e.g., opioids, benzodiazepines, barbiturates, alcohol, other antihistamines, tricyclic antidepressants): Increased sedation, respiratory depression, hypotension.
• Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
• QT-prolonging drugs (e.g., antiarrhythmics, certain antipsychotics, macrolide antibiotics): Increased risk of QT prolongation and torsades de pointes.
• Dopamine agonists (e.g., bromocriptine, cabergoline): Promethazine's antidopaminergic effects may antagonize their therapeutic effects.
• Epinephrine: Promethazine may reverse the pressor effect of epinephrine, leading to further blood pressure decrease.

• Antihypertensives: Additive hypotensive effects.
• Metoclopramide: Increased risk of extrapyramidal symptoms.
• Cholinergic inhibitors (e.g., donepezil, rivastigmine): Promethazine's anticholinergic effects may reduce their efficacy.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase promethazine levels, though clinical significance is often minor due to active metabolites.

• Not typically categorized as minor due to broad pharmacological effects.

• Excessive sedation
• Difficulty breathing or shallow breathing
• Dizziness or lightheadedness
• Confusion or disorientation
• Hallucinations
• Unusual muscle movements (dystonia, tardive dyskinesia)
• Blurred vision
• Dry mouth
• Difficulty urinating
• Constipation
• Yellowing of skin or eyes (jaundice)
• Unusual bleeding or bruising
• Sore throat or fever (signs of blood dyscrasias, rare)

Promethazine is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women. Neonatal jaundice, extrapyramidal symptoms, and prolonged sedation have been reported in infants whose mothers received promethazine shortly before delivery.

Promethazine is excreted into breast milk. The American Academy of Pediatrics considers it to be of 'concern' due to potential for sedation and respiratory depression in the infant, especially in neonates or premature infants. Use with caution, monitor infant for sedation, irritability, or poor feeding. Consider alternative agents if possible, especially for long-term use or in young infants.

Contraindicated in children younger than 2 years of age due to the risk of fatal respiratory depression. Use with extreme caution in children 2 years and older; use the lowest effective dose and avoid concomitant use with other respiratory depressants. Children may experience paradoxical excitation (restlessness, agitation) rather than sedation. Increased susceptibility to extrapyramidal reactions.

Elderly patients are more susceptible to the anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation), sedation, and hypotension. Use lower initial doses and titrate slowly. Monitor closely for adverse effects, especially confusion, falls, and respiratory depression. Avoid use in elderly patients with dementia-related psychosis due to increased mortality risk with antipsychotics (though promethazine is not an antipsychotic, it has similar properties).

• Promethazine suppositories are particularly useful for patients who cannot tolerate oral medications due to severe nausea or vomiting.
• Always confirm patient age before administering promethazine, especially in pediatric populations, due to the Black Box Warning for children under 2 years.
• Educate patients about the significant sedative effects and advise against driving or operating machinery.
• Warn patients about potential for photosensitivity and advise sun protection.
• Monitor for anticholinergic side effects, especially in the elderly, and advise on management (e.g., sugar-free candies for dry mouth, increased fiber for constipation).
• Be aware of the potential for paradoxical excitation in children, which can manifest as restlessness or agitation.
• Avoid co-administration with other CNS depressants or anticholinergic drugs whenever possible, or use with extreme caution and reduced doses.

• For nausea/vomiting: Ondansetron, Granisetron, Dimenhydrinate, Meclizine, Prochlorperazine.
• For allergic reactions: Diphenhydramine, Loratadine, Cetirizine, Fexofenadine.
• For sedation/insomnia: Diphenhydramine, Hydroxyzine, Zolpidem, Trazodone.

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.