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Diazepam Side Effects

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Common Diazepam Side Effects


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

Toxicity To Various Agents (570)
Completed Suicide (509)
Cardiac Arrest (440)
Respiratory Arrest (434)
Poisoning (391)
Death (378)
Overdose (157)
Cardio-respiratory Arrest (152)
Exposure Via Ingestion (127)
Anxiety (81)
Suicide Attempt (75)
Intentional Overdose (73)
Somnolence (72)
Hypotension (71)
Loss Of Consciousness (63)
Confusional State (61)
Dizziness (58)
Tachycardia (57)
Vomiting (53)
Headache (52)

➢ 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.

Diazepam Side Effects Reported to FDA



Diazepam Side Effect Report#9998296
Neonatal Respiratory Distress Syndrome, Oxygen Saturation Decreased, Motor Developmental Delay, Foetal Exposure During Pregnancy
This is a report of a male patient (weight: NA) from DE, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (dosage: As Required, start time:
May 04, 2013), combined with:
  • Opipramol
  • Melperone
  • Kadefungin
and developed a serious reaction and side effect(s): Neonatal Respiratory Distress Syndrome, Oxygen Saturation Decreased, Motor Developmental Delay, Foetal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam treatment in male patients, resulting in Neonatal Respiratory Distress Syndrome side effect.
Diazepam Side Effect Report#9995124
Neuroleptic Malignant Syndrome, Hyperthermia, Muscle Rigidity, Coma, Delirium, Blood Creatine Phosphokinase Increased
This report suggests a potential Diazepam (diazepam) (diazepam) Neuroleptic Malignant Syndrome side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: postoperative care and used Diazepam (diazepam) (diazepam) (dosage: NA) starting NS. After starting Diazepam (diazepam) (diazepam) the patient began experiencing various side effects, including: Neuroleptic Malignant Syndrome, Hyperthermia, Muscle Rigidity, Coma, Delirium, Blood Creatine Phosphokinase IncreasedAdditional drugs used concurrently:
  • Buprenorphine
  • Flunitrazepam
Although Diazepam (diazepam) (diazepam) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neuroleptic Malignant Syndrome, may still occur.
Diazepam Side Effect Report#9981032
Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, Fall
This Movement Disorder problem was reported by a consumer or non-health professional from DE. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diazepam (dosage: NA). The following drugs were being taken at the same time:
  • Levodopa
  • Pramipexole
  • Valdoxan
  • Zyprexa
  • Risperdal
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, FallThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Movement Disorder, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9970123
Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, Fall
This Movement Disorder side effect was reported by a consumer or non-health professional from DE. A 90-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diazepam (drug dosage: 45 Gtt Daily;), which was initiated on NS. Concurrently used drugs:
  • Pramipexole
  • Risperdal (3 Milligram Daily;)
  • Zyprexa (5 Milligram Daily;)
  • Valdoxan (25 Milligram Daily;)
  • Levodopa
.After starting to take Diazepam the consumer reported adverse symptoms, such as: Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, FallThese side effects may potentially be related to Diazepam. The patient was hospitalized.
Diazepam Side Effect Report#9932478
Feeling Abnormal, Anxiety
This is a report of a 59-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: irritable bowel syndrome, who was treated with Diazepam 10 Mg (dosage: 10 Mg, Tid Prn, Po, start time: 201311), combined with:
  • Dicyclomine
and developed a serious reaction and side effect(s): Feeling Abnormal, Anxiety after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam 10 Mg treatment in female patients, resulting in Feeling Abnormal side effect.
Diazepam Side Effect Report#9928655
Toxicity To Various Agents, Loss Of Consciousness, Disorientation
This report suggests a potential Diazepam Toxicity To Various Agents side effect(s) that can have serious consequences. A 80-year-old female patient (weight: NA) from FI was diagnosed with the following symptoms/conditions: NA and used Diazepam (dosage: NA) starting NS. After starting Diazepam the patient began experiencing various side effects, including: Toxicity To Various Agents, Loss Of Consciousness, DisorientationAdditional drugs used concurrently:
  • Oxazepam
  • Temazepam
  • Chlordiazepoxide
The patient was hospitalized. Although Diazepam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Diazepam Side Effect Report#9928652
Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Unresponsive To Stimuli
This Toxicity To Various Agents problem was reported by a health professional from FI. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: epilepsy. On NS this consumer started treatment with Diazepam (dosage: NA). The following drugs were being taken at the same time:
  • Oxazepam
  • Temazepam
  • Trimethoprim
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Loss Of Consciousness, Dyspnoea, Unresponsive To StimuliAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9919866
Toxicity To Various Agents, Suicide Attempt
This Toxicity To Various Agents side effect was reported by a pharmacist from IT. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Diazepam (drug dosage: NA), which was initiated on
Nov 01, 2013. Concurrently used drugs: NA..After starting to take Diazepam the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Suicide AttemptThese side effects may potentially be related to Diazepam.
Diazepam Side Effect Report#9905273
Hypoxic-ischaemic Encephalopathy, Unresponsive To Stimuli, Miosis, Tachycardia, Hypotension, Renal Impairment, Hyperkalaemia, Hypoglycaemia, Confusional State
This is a report of a 37-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (dosage: NA, start time: NS), combined with:
  • Methadone
  • Cannabis
  • Alcohol
and developed a serious reaction and side effect(s): Hypoxic-ischaemic Encephalopathy, Unresponsive To Stimuli, Miosis, Tachycardia, Hypotension, Renal Impairment, Hyperkalaemia, Hypoglycaemia, Confusional State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam treatment in male patients, resulting in Hypoxic-ischaemic Encephalopathy side effect. The patient was hospitalized and became disabled.
Diazepam Side Effect Report#9896864
Nephrolithiasis, Sepsis, Urinary Tract Infection, Dizziness, Balance Disorder, Muscular Weakness, Bladder Discomfort, Thyroid Function Test Abnormal, Nasopharyngitis
This report suggests a potential Diazepam Nephrolithiasis side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Diazepam (dosage: NA) starting
Dec 15, 2013. After starting Diazepam the patient began experiencing various side effects, including: Nephrolithiasis, Sepsis, Urinary Tract Infection, Dizziness, Balance Disorder, Muscular Weakness, Bladder Discomfort, Thyroid Function Test Abnormal, NasopharyngitisAdditional drugs used concurrently:
  • Adalimumab (Loading Dose)
  • Adalimumab
  • Prednisone
  • Levothyroxine Sodium
  • Phenazopyridine
  • Norvasc
Although Diazepam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nephrolithiasis, may still occur.
Diazepam Side Effect Report#9893291
Flushing, Hypotension
This Flushing problem was reported by a health professional from AU. A 39-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 06, 2013 this consumer started treatment with Diazepam (dosage: NA). The following drugs were being taken at the same time:
  • Cephazolin Sodium
  • Fentanyl
  • Pancuronium Bromide
  • Vancomycin Hydrochloride
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Flushing, HypotensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Flushing, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9891944
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a health professional from US. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diazepam (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Morphine
  • Meprobamate
.After starting to take Diazepam the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Diazepam.
Diazepam Side Effect Report#9891941
Poisoning, Exposure Via Ingestion
This is a report of a 54-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (diazepam) (diazepam) (dosage: NA, start time: NS), combined with:
  • Oxycodone (oxycodone) (oxycodone)
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam (diazepam) (diazepam) treatment in male patients, resulting in Poisoning side effect.
Diazepam Side Effect Report#9891931
Poisoning, Exposure Via Ingestion
This report suggests a potential Diazepam Poisoning side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Diazepam (dosage: NA) starting NS. After starting Diazepam the patient began experiencing various side effects, including: Poisoning, Exposure Via IngestionAdditional drugs used concurrently:
  • Amitriptyline (amitriptyline) (amitriptyline)
  • Methadone (methadone) (methadone)
  • (oxycodone)
  • Alprazolam (alprazolam) (alprazolam)
Although Diazepam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Diazepam Side Effect Report#9891924
Poisoning, Exposure Via Ingestion
This Poisoning problem was reported by a health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diazepam (dosage: Oral). The following drugs were being taken at the same time:
  • Clonazepam (Oral)
  • Acetaminophen/hydrocodone (procet) (Oral)
  • Hydromorphone (Oral)
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Poisoning, Exposure Via IngestionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9891921
Exposure Via Ingestion
This Exposure Via Ingestion side effect was reported by a health professional from US. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diazepam (diazepam) (diazepam) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Zolpidem (zolpidem) (zolpidem)
  • Fentanyl (fentanyl) (fentanyl)
  • Hydromorphone
  • Acetaminophen/oxycodone
.After starting to take Diazepam (diazepam) (diazepam) the consumer reported adverse symptoms, such as: Exposure Via IngestionThese side effects may potentially be related to Diazepam (diazepam) (diazepam).
Diazepam Side Effect Report#9891918
Poisoning, Exposure Via Ingestion
This is a report of a 52-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (diazepam) (diazepam) (dosage: NA, start time: NS), combined with:
  • Amitriptyline (amitriptyline) (amitriptyline)
  • Methadone (methadone) (methadone)
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam (diazepam) (diazepam) treatment in male patients, resulting in Poisoning side effect.
Diazepam Side Effect Report#9891916
Poisoning, Exposure Via Ingestion
This report suggests a potential Diazepam (diazepam) (diazepam) Poisoning side effect(s) that can have serious consequences. A 52-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Diazepam (diazepam) (diazepam) (dosage: Oral) starting NS. After starting Diazepam (diazepam) (diazepam) the patient began experiencing various side effects, including: Poisoning, Exposure Via IngestionAdditional drugs used concurrently:
  • Diltiazem (diltiazem) (diltiazem) (Oral)
  • Oxycodone (oxycodone) (oxycodone) (Oral)
  • Trazodone (trazodone) (trazodone) (Oral)
  • Cocaine (cocaine) (cocaine) (Oral)
  • Ethanol (ethanol) (ethanol) (Oral)
  • Quinine (Oral)
Although Diazepam (diazepam) (diazepam) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Diazepam Side Effect Report#9891909
Poisoning, Exposure Via Ingestion, Completed Suicide
This Poisoning problem was reported by a health professional from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diazepam (dosage: Oral). The following drugs were being taken at the same time:
  • Acetaminophen/oxycodone (Oral)
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Poisoning, Exposure Via Ingestion, Completed SuicideAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9891902
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a consumer or non-health professional from US. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diazepam (diazepam) (diazepam) (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Morphine
  • Oxycodone (oxycodone) (oxycodone)
.After starting to take Diazepam (diazepam) (diazepam) the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Diazepam (diazepam) (diazepam).
Diazepam Side Effect Report#9891891
Poisoning, Exposure Via Ingestion
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (diazepam) (diazepam) (dosage: NA, start time: NS), combined with:
  • Gabapentin (gabapentin) (gabapentin)
  • Buprenorphine/naloxone
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam (diazepam) (diazepam) treatment in female patients, resulting in Poisoning side effect.
Diazepam Side Effect Report#9891852
Poisoning, Exposure Via Ingestion
This report suggests a potential Diazepam Poisoning side effect(s) that can have serious consequences. A 45-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Diazepam (dosage: NA) starting NS. After starting Diazepam the patient began experiencing various side effects, including: Poisoning, Exposure Via IngestionAdditional drugs used concurrently:
  • Fentanyl (fentanyl) (fentanyl)
  • Methamphetamine (metamfetamine Hydrochloride) (metamfetamine Hydrochloride)
  • Alprazolam (alprazolam) (alprazolam)
Although Diazepam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Poisoning, may still occur.
Diazepam Side Effect Report#9891841
Poisoning, Exposure Via Ingestion
This Poisoning problem was reported by a consumer or non-health professional from US. A 45-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Diazepam (dosage: NA). The following drugs were being taken at the same time:
  • Acetaminophen/hydrocodone
  • Oxycodone (oxycodone) (oxycodone)
  • Alprazolam (alprazolam) (alprazolam)
When using Diazepam, the patient experienced the following unwanted symptoms/side effects: Poisoning, Exposure Via IngestionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Poisoning, may become evident only after a product is in use by the general population.
Diazepam Side Effect Report#9891833
Poisoning, Exposure Via Ingestion
This Poisoning side effect was reported by a health professional from US. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Diazepam (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Chlordiazepoxide
  • Acetaminophen/hydrocodone
  • Oxycodone (oxycodone) (oxycodone)
.After starting to take Diazepam the consumer reported adverse symptoms, such as: Poisoning, Exposure Via IngestionThese side effects may potentially be related to Diazepam.
Diazepam Side Effect Report#9891826
Poisoning, Exposure Via Ingestion
This is a report of a 42-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Diazepam (diazepam) (diazepam) (dosage: NA, start time: NS), combined with:
  • Procet
  • Ethanol (ethanol) (ethanol)
and developed a serious reaction and side effect(s): Poisoning, Exposure Via Ingestion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Diazepam (diazepam) (diazepam) treatment in male patients, resulting in Poisoning side effect.


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The appearance of Diazepam 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.

What are common Diazepam Side Effects for Women?

Women Side EffectsReports
Toxicity To Various Agents 245
Completed Suicide 210
Poisoning 176
Cardiac Arrest 155
Respiratory Arrest 150
Death 135
Overdose 72
Cardio-respiratory Arrest 64
Exposure Via Ingestion 62
Anxiety 55

What are common Diazepam Side Effects for Men?

Men Side EffectsReports
Toxicity To Various Agents 304
Poisoning 206
Death 173
Cardiac Arrest 158
Respiratory Arrest 156
Completed Suicide 150
Overdose 74
Exposure Via Ingestion 64
Cardio-respiratory Arrest 56
Confusional State 43

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.

    Diazepam 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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    How Effective is Diazepam for You?

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    Diazepam Safety Alerts, Active Ingredients, Usage Information

    NDC0054-3185
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDiazepam Intensol
    NameDiazepam Intensol
    Dosage FormSOLUTION, CONCENTRATE
    RouteORAL
    On market since19870403
    LabelerRoxane Laboratories, Inc
    Active Ingredient(s)DIAZEPAM
    Strength(s)5
    Unit(s)mg/mL
    Pharma ClassBenzodiazepine [EPC],Benzodiazepines [Chemical/Ingredient]

    Diazepam Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3307

    Diazepam safety alerts: 2006

    Reported deaths: 1928

    Reported hospitalizations: 689

    Diastat AcuDial (diazepam rectal gel)

    Audience: Neurologists, pharmacists and consumers
    [Posted 03/30/2006] Valeant Pharmaceuticals International and FDA notified healthcare professionals of complaints the company received concerning small cracks at the base of the plastic tip of the applicators with resulting leakage of the medication when the plunger is depressed, preventing full dosing and potentially resulting in a sub-optimal therapeutic response. Diastat is indicated for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of anti-epileptic drugs, who require intermittent use of diazepam to control bouts of increased seizure activity. Complaints were received for the Diastat AcuDial Applicators 10mg and 20mg product twin packs.

    Healthcare professionals should advise patients using the product of this issue and to return any product with a cracked tip to their pharmacy for immediate replacement. Pharmacists should inspect all product on their shelves and contact Rx Hope at 1-800-511-2120 or www.Rxhope.com for replacement product. Emergency support should always be available in case seizures are not controllable with Diastat AcuDial.

    [March 30, 2006 - Drug Information Page - FDA]
    [February 21, 2006 - Dear Doctor Letter - Valeant]
    [February 21, 2006 - Dear Pharmacist Letter - Valeant]

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