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Sominex Side Effects

PatientsVille

Common Sominex Side Effects


The most commonly reported Sominex side effects (click to view or check a box to report):

Intentional Misuse (6)
Somnolence (5)
Fatigue (4)
Overdose (4)
Dependence (4)
Pain In Extremity (3)
Dyskinesia (2)
Intentional Overdose (2)
Depressed Level Of Consciousness (2)
Incoherent (2)
Joint Dislocation (2)
Impaired Driving Ability (2)
Hallucination (2)
Suicidal Ideation (2)
Performance Status Decreased (2)
Muscle Twitching (2)
Pruritus (2)
Underdose (2)
Vomiting (2)
Loss Of Consciousness (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Sominex Side Effects Reported to FDA



Sominex Side Effect Report#8460176-6
Insomnia, Suicidal Ideation
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: insomnia,depression,chronic obstructive pulmonary disease, who was treated with Sominex (dosage: NA, start time:
Mar 27, 2012), combined with:
  • Zoloft
  • Trial Procedure
  • Bi 1744+tiotropium
and developed a serious reaction and side effect(s): Insomnia, Suicidal Ideation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in male patients, resulting in Insomnia side effect.
Sominex Side Effect Report#8459455-8
Suicidal Ideation
This report suggests a potential Sominex Suicidal Ideation side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: insomnia,depression,chronic obstructive pulmonary disease and used Sominex (dosage: NA) starting
Mar 27, 2012. After starting Sominex the patient began experiencing various side effects, including: Suicidal IdeationAdditional drugs used concurrently:
  • Zoloft
  • Bi 1744+tiotropium
  • Trial Procedure
  • Proair Hfa
Although Sominex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Suicidal Ideation, may still occur.
Sominex Side Effect Report#8351390-9
Bursitis, Blood Cortisol Increased, Bone Fragmentation, Pleural Effusion, Pneumonia, Intestinal Obstruction, Cardiac Disorder, Pulmonary Oedema, Diarrhoea
This Bursitis problem was reported by a physician from United States. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hypersensitivity. On
Jan 01, 2001 this consumer started treatment with Sominex (diphenhydramine Hydrochloride) (dosage: NA). The following drugs were being taken at the same time: NA. When using Sominex (diphenhydramine Hydrochloride), the patient experienced the following unwanted symptoms/side effects: Bursitis, Blood Cortisol Increased, Bone Fragmentation, Pleural Effusion, Pneumonia, Intestinal Obstruction, Cardiac Disorder, Pulmonary Oedema, DiarrhoeaThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bursitis, may become evident only after a product is in use by the general population.
Sominex Side Effect Report#6107682-7
Eye Pain, Glaucoma, Vision Blurred
This Eye Pain side effect was reported by a consumer or non-health professional from United States. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: sleep disorder.The patient was prescribed Sominex (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sominex the consumer reported adverse symptoms, such as: Eye Pain, Glaucoma, Vision BlurredThese side effects may potentially be related to Sominex.
Sominex Side Effect Report#5535614-9
Depressed Level Of Consciousness, Impaired Driving Ability, Incoherent, Initial Insomnia, Muscle Twitching, Performance Status Decreased, Pruritus, Somnolence
This is a report of a 45-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: insomnia, who was treated with Sominex (dosage: 2tab Single Dose, start time:
Mar 06, 2007), combined with: NA. and developed a serious reaction and side effect(s): Depressed Level Of Consciousness, Impaired Driving Ability, Incoherent, Initial Insomnia, Muscle Twitching, Performance Status Decreased, Pruritus, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in male patients, resulting in Depressed Level Of Consciousness side effect.
Sominex Side Effect Report#5502887-8
Hallucination
This report suggests a potential Sominex Hallucination side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Sominex (dosage: NA) starting NS. After starting Sominex the patient began experiencing various side effects, including: HallucinationAdditional drugs used concurrently: NA. Although Sominex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Sominex Side Effect Report#5299481-3
Intentional Overdose, Somnolence
This Intentional Overdose problem was reported by a consumer or non-health professional from United States. A 23-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: intentional overdose. On
Apr 13, 2007 this consumer started treatment with Sominex (dosage: 15capl Single Dose). The following drugs were being taken at the same time: NA. When using Sominex, the patient experienced the following unwanted symptoms/side effects: Intentional Overdose, SomnolenceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intentional Overdose, may become evident only after a product is in use by the general population.
Sominex Side Effect Report#5268543-9
Anxiety, Poor Quality Sleep, Somnolence
This Anxiety side effect was reported by a consumer or non-health professional from United States. A 35-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Sominex (drug dosage: As Directed X 3 Po), which was initiated on
Aug 01, 1999. Concurrently used drugs: NA..After starting to take Sominex the consumer reported adverse symptoms, such as: Anxiety, Poor Quality Sleep, SomnolenceThese side effects may potentially be related to Sominex.
Sominex Side Effect Report#5260857-1
Depressed Level Of Consciousness, Impaired Driving Ability, Incoherent, Initial Insomnia, Muscle Twitching, Performance Status Decreased, Pruritus, Somnolence
This is a report of a 45-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Sominex (dosage: 2tab Single Dose, start time:
Mar 06, 2007), combined with: NA. and developed a serious reaction and side effect(s): Depressed Level Of Consciousness, Impaired Driving Ability, Incoherent, Initial Insomnia, Muscle Twitching, Performance Status Decreased, Pruritus, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in male patients, resulting in Depressed Level Of Consciousness side effect.
Sominex Side Effect Report#5237140-3
Joint Dislocation, Pain In Extremity, Underdose
This report suggests a potential Sominex Joint Dislocation side effect(s) that can have serious consequences. A 51-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Sominex (dosage: NA) starting NS. After starting Sominex the patient began experiencing various side effects, including: Joint Dislocation, Pain In Extremity, UnderdoseAdditional drugs used concurrently: NA. Although Sominex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Joint Dislocation, may still occur.
Sominex Side Effect Report#5237114-2
Joint Dislocation, Pain In Extremity, Underdose
This Joint Dislocation problem was reported by a consumer or non-health professional from United States. A 51-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Sominex (dosage: NA). The following drugs were being taken at the same time: NA. When using Sominex, the patient experienced the following unwanted symptoms/side effects: Joint Dislocation, Pain In Extremity, UnderdoseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Joint Dislocation, may become evident only after a product is in use by the general population.
Sominex Side Effect Report#5102435-0
Loss Of Consciousness, Overdose
This Loss Of Consciousness side effect was reported by a consumer or non-health professional from United States. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Sominex (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Sominex the consumer reported adverse symptoms, such as: Loss Of Consciousness, OverdoseThese side effects may potentially be related to Sominex.
Sominex Side Effect Report#5094285-9
Fatigue, Overdose, Visual Acuity Reduced
This is a report of a 66-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: sleep disorder, who was treated with Sominex (dosage: NA, start time:
Jan 01, 2006), combined with:
  • Hyzaar
  • Ditropan
  • Docusate
  • Lipitor
  • Norvasc
and developed a serious reaction and side effect(s): Fatigue, Overdose, Visual Acuity Reduced after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in male patients, resulting in Fatigue side effect.
Sominex Side Effect Report#4928895-3
Intentional Overdose, Loss Of Consciousness
This report suggests a potential Sominex Maximum Strength Caplets Intentional Overdose side effect(s) that can have serious consequences. A 29-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: intentional overdose and used Sominex Maximum Strength Caplets (dosage: 16capl Single Dose) starting
Feb 28, 2006. After starting Sominex Maximum Strength Caplets the patient began experiencing various side effects, including: Intentional Overdose, Loss Of ConsciousnessAdditional drugs used concurrently: NA.The patient was hospitalized. Although Sominex Maximum Strength Caplets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Overdose, may still occur.
Sominex Side Effect Report#4701229-5
Carpal Tunnel Syndrome, Cervicobrachial Syndrome, Constipation, Dependence, Dyskinesia, Dyspnoea, Eczema, Fatigue
This Carpal Tunnel Syndrome problem was reported by a physician from . A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: insomnia. On
Jan 01, 1999 this consumer started treatment with Sominex (dosage: NA). The following drugs were being taken at the same time:
  • Benadryl
When using Sominex, the patient experienced the following unwanted symptoms/side effects: Carpal Tunnel Syndrome, Cervicobrachial Syndrome, Constipation, Dependence, Dyskinesia, Dyspnoea, Eczema, FatigueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Carpal Tunnel Syndrome, may become evident only after a product is in use by the general population.
Sominex Side Effect Report#4650941-5
Dependence, Dyskinesia, Headache, Intentional Misuse, Pain In Extremity, Visual Disturbance
This Dependence side effect was reported by a physician from . A 45-year-old male patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Sominex (drug dosage: NA), which was initiated on
Jan 01, 1999. Concurrently used drugs: NA..After starting to take Sominex the consumer reported adverse symptoms, such as: Dependence, Dyskinesia, Headache, Intentional Misuse, Pain In Extremity, Visual DisturbanceThese side effects may potentially be related to Sominex.
Sominex Side Effect Report#4643872-8
Fatigue, Hallucination, Intentional Misuse, Overdose
This is a report of a 25-year-old female patient (weight: NA) from , suffering from the following health symptoms/conditions: NA, who was treated with Sominex (dosage: 32tab Single Dose, start time:
Mar 03, 2005), combined with: NA. and developed a serious reaction and side effect(s): Fatigue, Hallucination, Intentional Misuse, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in female patients, resulting in Fatigue side effect. The patient was hospitalized.
Sominex Side Effect Report#4642527-3
Intentional Misuse, Suicide Attempt, Vomiting
This report suggests a potential Sominex Intentional Misuse side effect(s) that can have serious consequences. A 19-year-old male patient (weight: NA) from was diagnosed with the following symptoms/conditions: ill-defined disorder and used Sominex (dosage: 12tab Per Day) starting
Apr 12, 2005. After starting Sominex the patient began experiencing various side effects, including: Intentional Misuse, Suicide Attempt, VomitingAdditional drugs used concurrently: NA. Although Sominex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Misuse, may still occur.
Sominex Side Effect Report#4641390-4
Balance Disorder, Intentional Misuse, Nausea, Vomiting
This Balance Disorder problem was reported by a consumer or non-health professional from . A 16-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 11, 2005 this consumer started treatment with Sominex Regular Strength Caplets (dosage: NA). The following drugs were being taken at the same time:
  • Zoloft (75mg Per Day)
  • Adderall 20
When using Sominex Regular Strength Caplets, the patient experienced the following unwanted symptoms/side effects: Balance Disorder, Intentional Misuse, Nausea, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Balance Disorder, may become evident only after a product is in use by the general population.
Sominex Side Effect Report#4641389-8
Dependence
This Dependence side effect was reported by a consumer or non-health professional from . A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: insomnia.The patient was prescribed Sominex Regular Strength Caplets (drug dosage: NA), which was initiated on
Jan 01, 1997. Concurrently used drugs: NA..After starting to take Sominex Regular Strength Caplets the consumer reported adverse symptoms, such as: DependenceThese side effects may potentially be related to Sominex Regular Strength Caplets.
Sominex Side Effect Report#4607823-4
Fatigue, Intentional Misuse, Overdose
This is a report of a 25-year-old female patient (weight: NA) from , suffering from the following health symptoms/conditions: NA, who was treated with Sominex (dosage: 32tab Single Dose, start time:
Mar 03, 2005), combined with: NA. and developed a serious reaction and side effect(s): Fatigue, Intentional Misuse, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sominex treatment in female patients, resulting in Fatigue side effect. The patient was hospitalized.
Sominex Side Effect Report#4582695-5
Intentional Misuse, Somnolence
This report suggests a potential Sominex Maximum Strength Caplets Intentional Misuse side effect(s) that can have serious consequences. A 30-year-old patient (weight: NA) from was diagnosed with the following symptoms/conditions: NA and used Sominex Maximum Strength Caplets (dosage: NA) starting
Feb 09, 2005. After starting Sominex Maximum Strength Caplets the patient began experiencing various side effects, including: Intentional Misuse, SomnolenceAdditional drugs used concurrently: NA. Although Sominex Maximum Strength Caplets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Misuse, may still occur.
Sominex Side Effect Report#4556808-5
Dependence, Energy Increased
This Dependence problem was reported by a consumer or non-health professional from . A 30-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sleep disorder. On
Nov 01, 2004 this consumer started treatment with Sominex (dosage: NA). The following drugs were being taken at the same time: NA. When using Sominex, the patient experienced the following unwanted symptoms/side effects: Dependence, Energy IncreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dependence, may become evident only after a product is in use by the general population.



The appearance of Sominex on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Sominex reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Sominex Safety Alerts, Active Ingredients, Usage Information

    NDC0135-0057
    TypeHUMAN OTC DRUG
    Proprietary NameSominex
    Namediphenhydramine HCl
    Dosage FormTABLET
    RouteORAL
    On market since20101108
    LabelerGlaxoSmithKline Consumer Healthcare LP
    Active Ingredient(s)DIPHENHYDRAMINE HYDROCHLORIDE
    Strength(s)25
    Unit(s)mg/1
    Pharma Class

    More About Sominex

    Side Effects reported to FDA: 23

    Sominex safety alerts: No

    Reported hospitalizations: 3

    Latest Sominex clinical trials