Side Effects of doxylamine: A Synthesis of Findings from 21 Studies

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This analysis is based on research papers included in PubMed, but medical research is constantly evolving and may not fully reflect the latest findings. There may also be biases towards certain research areas.

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Original Abstract of the Article

Main Research Findings

Doxylamine is a first-generation H1 receptor antagonist that is widely used to relieve allergy and cold symptoms, but it is known to cause side effects such as drowsiness and sedation. 12 These side effects can impair performance in tasks that require concentration, such as driving or operating machinery, and there are concerns that they could contribute to accidents. 12

Doxylamine is also used as a medication for insomnia. 19 Short-term use of doxylamine is generally associated with mild side effects like drowsiness and sedation, and serious side effects that lead to treatment discontinuation are rarely observed. 19 However, overdose of doxylamine can cause severe side effects such as impaired consciousness, seizures, and coma. 10 Additionally, there is evidence suggesting that using doxylamine during early pregnancy may increase the risk of birth defects. 9 Extra caution should be exercised when administering doxylamine to children. 6

Doxylamine can interact with other medications. 14 It is crucial to consult with a physician or pharmacist before taking doxylamine and to adhere to the prescribed dosage.

Reasons for Side Effects

Doxylamine's side effects are thought to be caused by its inhibition of histamine H1 receptors. Histamine is a neurotransmitter involved in allergic and inflammatory responses. By inhibiting histamine H1 receptors, doxylamine suppresses allergic symptoms and exhibits a sedative effect. However, histamine H1 receptors are found in various tissues, including the brain and heart, and doxylamine can also inhibit these receptors. This is believed to be the reason why doxylamine causes side effects such as drowsiness and sedation.

Common Side Effects

Drowsiness

Doxylamine is well-known for causing drowsiness and sedation as side effects. 18 19 11 Activities that require concentration, such as driving or operating machinery, should be avoided after taking doxylamine. 12 19

Dry Mouth

Doxylamine may cause side effects such as dry mouth. 19 11 13 18

Constipation

Doxylamine may cause constipation as a side effect. 19

Dizziness

Doxylamine may cause dizziness as a side effect. 19 13

Vision Problems

Doxylamine may cause vision problems as a side effect. 10

Gastrointestinal Symptoms

Doxylamine may cause gastrointestinal symptoms as a side effect. 19

Other

Other potential side effects of doxylamine include tachycardia, rash, palpitations, indigestion, urinary retention, and difficulty urinating. 19 13

Side Effects Management

Drowsiness

If you take doxylamine, you should avoid activities that require concentration, such as driving or operating machinery. 12 19

Dry Mouth

If you experience dry mouth, drink plenty of fluids.

Constipation

If you experience constipation, try to eat foods high in fiber and drink plenty of water.

Dizziness

If you experience dizziness, get up slowly when standing up. Also, consult a doctor if necessary.

Vision Problems

If you experience vision problems, consult a doctor.

Gastrointestinal Symptoms

If you experience gastrointestinal symptoms, consult a doctor.

Comparison Between Studies

Commonalities

Several studies have confirmed that doxylamine is widely used to relieve allergy and cold symptoms and that it can cause side effects such as drowsiness and sedation. 12 19 11 18

Differences

The severity and frequency of side effects caused by doxylamine can vary between studies. This is likely due to factors such as the age, sex, health status, dosage, and concomitant medications of the study participants.

Considerations for Real-Life Applications

Because doxylamine can cause side effects such as drowsiness and sedation, it should be avoided when performing tasks that require concentration, such as driving or operating machinery. 12 19 Doxylamine can interact with other medications. 14 It is important to consult a doctor or pharmacist before taking doxylamine and to follow the prescribed dosage instructions.

Limitations of Current Research

Research on the side effects of doxylamine is still not comprehensive, especially regarding long-term side effects. Further research is needed in this area.

Future Research Directions

Research is needed to evaluate the long-term side effects of doxylamine and to develop new medications that can reduce these side effects.

Conclusion

Doxylamine is an effective drug for relieving allergy and cold symptoms, but it can cause side effects such as drowsiness and sedation. 12 19 11 18 It is important to consult a doctor or pharmacist before taking doxylamine and to follow the prescribed dosage instructions.

Literature analysis of 21 papers
Positive Content
14
Neutral Content
0
Negative Content
7
Article Type
6
1
1
2
21
1.

A double-blind randomised controlled trial of paracetamol, diclofenac or the combination for pain relief after caesarean section.

Author: MunishankarB, FettesP, MooreC, McLeodG A

Pain relief

A combination of diclofenac and paracetamol was found to be more effective in reducing morphine use after elective caesarean section than paracetamol alone.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Effects of Pipemidic Acid, Phenazopyridine HCL and Sodium Diclofenac on Pain Perception Following Endoscopic Urological Surgery: Double-blinded Randomized-Controlled Trial.

Author: YuriPrahara, AliZulfikar, RasyidNur, BirowoPonco

Pain relief
Endoscopic urological surgery

Oral analgesics, including pipemidic acid, phenazopyridine, and sodium diclofenac, were effective in reducing pain after endoscopic urological surgery in 80 patients. Pipemidic acid demonstrated a superior analgesic effect compared to the other two drugs.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

3.

Exogenous hormones and other drug exposures of children with congenital heart disease.

Author: RothmanK J, FylerD C, GoldblattA, KreidbergM B

Cardiac malformation

There was a small positive association between estrogen/progesterone exposure and congenital heart disease in infants, but no association with specific types of defects. Other drugs were also reported more frequently by mothers of infants with congenital heart disease.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

4.

First-trimester drug use and congenital disorders.

Author: AseltonP, JickH, MilunskyA, HunterJ R, StergachisA

Congenital disorders

No strong associations were found between commonly used drugs and major congenital disorders in a cohort of infants born to mothers who used various drugs during the first trimester of pregnancy.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

6.

Pediatric Fatalities Associated With Over-the-Counter Cough and Cold Medications.

Author: HalmoLaurie Seidel, WangGeorge Sam, ReynoldsKate M, Delva-ClarkHeather, Rapp-OlssonMalin, BannerWilliam, BondG Randall, KauffmanRalph E, PalmerRobert B, PaulIan M, GreenJody L, DartRichard C

Fatalities

This study describes fatalities associated with exposures to over-the-counter cough and cold medications in children younger than 12 years old.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Safety Profile of Cough and Cold Medication Use in Pediatrics.

Author: GreenJody L, WangGeorge Sam, ReynoldsKate M, BannerWilliam, BondG Randall, KauffmanRalph E, PalmerRobert B, PaulIan M, DartRichard C

Cough and cold relief
Agitation
Ataxia
Hallucinations
Mydriasis
Somnolence
Tachycardia

This study describes the safety profile of cough and cold medications (CCMs) in children <12 years of age from a multisystem surveillance program. The rate of AEs associated with CCMs in children was low. Fatalities occurred even less frequently. No fatality involved a therapeutic dose.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

9.

Maternal drugs and congenital heart disease.

Author: ZierlerS

Congenital Heart Disease Risk

The majority of congenital heart malformations cannot be attributed to maternal drug use during pregnancy, despite the possible risks associated with ethanol, anticonvulsants, lithium, and exogenous female hormones.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Doxylamine succinate overdose: Slurred speech and visual hallucination.

Author: Derinöz-GüleryüzOkşan

Anticholinergic side effects
Doxylamine succinate overdose
Slurred speech
Visual hallucination

A case report describes slurred speech and visual hallucinations after doxylamine succinate overdose, highlighting the risk of central adverse effects, even though they are rare.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

11.

Treatment of migraine attacks with an analgesic combination (Mersyndol).

Author: SomervilleB W

Better than placebo
Effective for migraine
Drowsiness

Mersyndol, a combination of paracetamol, codeine phosphate, doxylamine succinate, and caffeine, was significantly better than placebo in completely relieving migraine pain and was clearly superior in partially relieving the pain. It was suggested as a potential alternative to ergotamine. The most common side effect was drowsiness caused by the antihistamine component.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Multidrug toxicity involving sumatriptan.

Author: KnittelJessica L, VorceShawn P, LevineBarry, HughesRhome L, BosyThomas Z

Acute mixed drug toxicity
Multidrug fatality

This report describes a multidrug fatality involving sumatriptan, highlighting the potential risks associated with high doses of the medication.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

15.

A comparison of crossover versus parallel-group design in the evaluation of analgesic efficacy after molar extraction.

Author: MargaroneJ E, LiebowC, HallR E, BraunR E, WeinerM

Pain relief

This study compared the analgesic effects of Empirin with codeine, Mersyndol, and placebo using both crossover and parallel-group designs. Both Empirin with codeine and Mersyndol were found to be more effective than placebo.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Treatment of primary insomnia.

Author: RingdahlErika N, PereiraSusan L, DelzellJohn E

Improved sleep
Side effects

Insomnia affects many adults, ranging from occasional sleeplessness to long-term difficulties. The article discusses the various ways to diagnose and treat insomnia, emphasizing non-pharmacological approaches as effective and safe options. It also mentions different medications available for short-term use, including those with minimal side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

17.

Comparison of lactated Ringer's solution and 0.9% saline in the treatment of rhabdomyolysis induced by doxylamine intoxication.

Author: ChoYoung Soon, LimHoon, KimSeung Ho

Rhabdomyolysis treatment

Lactated Ringer's solution (LR) is more useful than 0.9% saline (NS) in the treatment of rhabdomyolysis induced by doxylamine intoxication.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

18.

A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection.

Author: EcclesR, Van CauwenbergeP, TetzloffW, BorumP

Reduced runny nose
Reduced sneezing
Drowsiness

Doxylamine was effective in reducing runny nose and sneezing symptoms in patients with the common cold. The most common side effect was drowsiness.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

[Effectiveness of reslip (doxylamine) in short-term insomnia: multicenter comparative randomized study].

Author: MelnikovA Yu, LavrikS Yu, BikbulatovaL F, RagineneI G, IvanovaYa A, ZakharovA V

Daytime sleepiness improvement
Insomnia improvement
Sleep quality improvement
Mild side effects

Doxylamine (Reslip) is as effective as donormyl for the treatment of short-term insomnia and is well tolerated by patients.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : Russian

20.

Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis.

Author: De CrescenzoFranco, D'AlòGian Loreto, OstinelliEdoardo G, CiabattiniMarco, Di FrancoValeria, WatanabeNorio, KurtulmusAyse, TomlinsonAnneka, MitrovaZuzana, FotiFrancesca, Del GiovaneCinzia, QuestedDigby J, CowenPhil J, BarbuiCorrado, AmatoLaura, EfthimiouOrestis, CiprianiAndrea

Pharmacological treatments for insomnia

This study aimed to compare the effectiveness of different pharmacological treatments for insomnia in adults. While behavioral, cognitive, and pharmacological interventions are effective for insomnia, medications are more widely used due to resource limitations.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

21.

Protein biomarkers for in vitro testing of embryotoxicity.

Author: GroebeKarlfried, HayessKatrin, Klemm-MannsMartina, SchwallGerhard, WoznyWoijciech, SteemansMargino, PetersAnnelieke K, SastriChaturvedala, JaeckelPetra, StegmannWerner, ZengerlingHelmut, SchopfRainer, PoznanovicSlobodan, StummannTina C, SeilerAndrea, SpielmannHorst, SchrattenholzAndre

Novel in vitro models

Two distinct classes of toxic substances were identified in mouse embryonic stem cells differentiated into contracting cardiomyocytes. These substances induced different proteomic response patterns.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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