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promethazine

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Brand names: Phenergan

Phenothiazine Antiemetic / Antihistamine Rx

Promethazine suppositories are a medicine that can help with allergies, motion sickness, nausea, vomiting, and sleep problems. It works by blocking certain natural substances in your body.

Drug Shortage Alert

promethazine is currently listed as in shortage by the FDA. Affected manufacturer: Hikma Pharmaceuticals USA, Inc.. Status: Available.

View all drug shortages →

Drug Pricing (NADAC)

Generic Price

$2.24/unit

Generic Available

Yes (26 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine can treat allergy symptoms like a runny nose or itchy eyes.

Common side effects

Drowsiness, Dry mouth, Blurred vision

Key warnings

Promethazine suppositories should not be used in children under 2 years old because it can cause serious breathing problems, which can be fatal.

How It Works

Promethazine belongs to a class of drugs called antihistamines and antiemetics. It works by blocking histamine, a substance in the body that causes allergic symptoms. It also affects the part of the brain that controls nausea and vomiting.

How to Take It

This medicine comes as a suppository that you insert into your rectum. For allergies, you might use it before bed, or several times a day. For motion sickness, take it 30-60 minutes before traveling, and again 8-12 hours later if needed. Follow your doctor's instructions on how often to use it.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if promethazine can harm an unborn baby or pass into breast milk.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store the suppositories in the refrigerator between 36°F and 46°F (2°C and 8°C) in a tightly closed container.

Side Effects (from patient reports)

Based on 13,190 FDA adverse event reports.

Feeling sick to your stomach
2,534
Throwing up
1,736
Aches or soreness
1,457
Feeling very tired
1,408
Loose or watery stools
1,272
Pain in your head
1,192
Difficulty breathing
1,066
Feeling worried or nervous
865
Medicine not working
856
Weakness
804

FDA Adverse Event Report Analysis

Detailed analysis of 17,969 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1996–2025.

Total Reports

17,969

Death-Related Reports

1,754

Hospitalization Reports

7,143

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 12,671 (75%)
Male 4,129 (25%)

Age Distribution

0–17 448
18–44 3,868
45–64 5,108
65–74 1,703
75+ 945

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 NAUSEA 2,530
2 VOMITING 1,734
3 PAIN 1,453
4 FATIGUE 1,408
5 DIARRHOEA 1,271
6 HEADACHE 1,191
7 DYSPNOEA 1,063
8 ANXIETY 864
9 DRUG INEFFECTIVE 855
10 ASTHENIA 804
11 PNEUMONIA 791
12 ABDOMINAL PAIN 776
13 PYREXIA 768
14 DIZZINESS 752
15 MALAISE 733

Reactions in Death Reports

DEATH 521
NAUSEA 213
TOXICITY TO VARIOUS AGENTS 204
VOMITING 172
PNEUMONIA 152
FATIGUE 140
DYSPNOEA 135
ASTHENIA 120
CARDIAC ARREST 116
DIARRHOEA 113

Reactions in Hospitalization Reports

NAUSEA 1,057
VOMITING 903
PAIN 777
DIARRHOEA 615
PNEUMONIA 608
DYSPNOEA 602
FATIGUE 576
ABDOMINAL PAIN 506
HEADACHE 486
PYREXIA 484

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Promethazine suppositories should not be used in children under 2 years old because it can cause serious breathing problems, which can be fatal. Use with caution in children 2 years and older, and use the lowest effective dose. Avoid giving this medicine with other drugs that can also cause breathing problems.

Known Drug Interactions

Epinephrine - Because of the potential for promethazine HCl to reverse epinephrine's vasopressor effect, epinephrine should NOT be used to treat hypotension associated with Promethazine HCl Suppositories overdose.

Mechanism: Promethazine can block the way epinephrine normally raises blood pressure, which might cause blood pressure to drop even lower.

What to do: Do not use epinephrine to treat low blood pressure if a person has taken too much promethazine.

7.2 Potential for Other Drugs to Affect Penciclovir No clinically significant alterations in penciclovir pharmacokinetics were observed following single-dose administration of 500 mg famciclovir after pretreatment with multiple doses of allopurinol, cimetidine, theophylline, zidovudine, promethazine, when given shortly after an antacid (magnesium and aluminum hydroxide), or concomitantly with emtricitabine. Clinical interaction studies of famciclovir with cimetidine and promethazine, in vitro inhibitors of aldehyde oxidase, did not show relevant effects on the formation of penciclovir.

Mechanism: Promethazine does not significantly affect how famciclovir is processed or activated by the body.

What to do: These medicines can be taken together safely as prescribed by your doctor.

Promethazine: Coadministration of a single dose of zaleplon and promethazine (10 and 25 mg, respectively) resulted in a 15% decrease in maximal plasma concentrations of zaleplon, but no change in the area under the plasma concentration-time curve. However, the pharmacodynamics of coadministration of zaleplon and promethazine have not been evaluated.

Mechanism: Promethazine slightly reduces the highest level of zaleplon in your blood, but the total amount in your body remains about the same.

What to do: Be careful when combining these drugs, as doctors are not yet sure how they might affect your coordination or sleepiness when used together.

Common Questions

Can I use this for my baby's cold?
No, you should not use promethazine suppositories in children under 2 years old.
Will this medicine make me sleepy?
Yes, drowsiness is a common side effect.
Can I drink alcohol while using this?
No, avoid alcohol because it can increase sleepiness.
How long does it take for this medicine to work?
It should start working within 30-60 minutes.
What should I do if I feel dizzy?
Sit or lie down to avoid falling.
Can I drive after using this medicine?
Do not drive or operate heavy machinery until you know how this medicine affects you.
Can I use this for asthma?
No, this medicine should not be used for asthma.
What if I have an allergic reaction?
Seek immediate medical attention if you have signs of an allergic reaction, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Can I use this with other medicines?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How often can I use this medicine?
Follow your doctor's instructions on how often to use it.
What are the common side effects of promethazine?
The most commonly reported side effects of promethazine include Drowsiness, Dry mouth, Blurred vision, Dizziness. Based on 13,190 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does promethazine interact with other medications?
Yes, promethazine has 3 known drug interactions. Notable interactions include epinephrine, famciclovir, zaleplon. Always inform your doctor about all medications you are taking.
What drug class is promethazine?
promethazine belongs to the Phenothiazine Antiemetic / Antihistamine drug class. It requires a prescription (Rx). This medicine can treat allergy symptoms like a runny nose or itchy eyes.
Is promethazine safe during pregnancy?
Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if promethazine can harm an unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Is promethazine currently in shortage?
Yes, promethazine is currently listed as in shortage by the FDA. Affected manufacturer: Hikma Pharmaceuticals USA, Inc.. Status: Available. Visit the FDA Drug Shortages database for the latest updates.

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What the FDA Data Shows for promethazine

The FDA label for promethazine (sold under brand names such as Phenergan) classifies it as a prescription-only medication in the Phenothiazine Antiemetic / Antihistamine class. This medicine can treat allergy symptoms like a runny nose or itchy eyes. Official labeling lists 4 commonly reported side effects, including Drowsiness, Dry mouth, Blurred vision.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 13,190 voluntary reports. The database also lists 3 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $2.24.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: June 30, 2023

All federal data sources used on this page