Common Pregabalin Side Effects


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

Completed Suicide (61)
Confusional State (54)
Cardiac Arrest (51)
Respiratory Arrest (46)
Dizziness (44)
Convulsion (40)
Somnolence (37)
Vomiting (29)
Oedema Peripheral (29)
Withdrawal Syndrome (28)
Fall (27)
Death (26)
Fatigue (25)
Status Epilepticus (25)
Agitation (24)
Tremor (23)
Pneumonia (22)
Condition Aggravated (22)
Depression (21)
Intentional Overdose (21)

➢ 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.

Pregabalin Side Effects Reported to FDA



Pregabalin Side Effect Report#9983663
Suicidal Ideation, Depression
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fibromyalgia,pain, who was treated with Pregabalin (dosage: 75, Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Suicidal Ideation, Depression after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in female patients, resulting in Suicidal Ideation side effect.
Pregabalin Side Effect Report#9935094
Raynaud^s Phenomenon, Cyanosis
This report suggests a potential Pregabalin Raynaud^s Phenomenon side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: back pain and used Pregabalin (dosage: 225 Mg, 2x/day) starting
Feb 14, 2014. After starting Pregabalin the patient began experiencing various side effects, including: Raynaud^s Phenomenon, CyanosisAdditional drugs used concurrently:
  • Alendronic Acid (Unk)
  • Alendronic Acid (Unk)
  • Amitriptyline Hydrochloride (Unk)
  • Ispaghula Husk (Unk)
  • Lansoprazole (Unk)
  • Laxido (Unk)
  • Paracetamol (Unk)
  • Seretide (Unk)
Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Raynaud^s Phenomenon, may still occur.
Pregabalin Side Effect Report#9929959
Dyskinesia
This Dyskinesia problem was reported by a health professional from TR. A 70-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: restless legs syndrome,diabetic neuropathy. On NS this consumer started treatment with Pregabalin (dosage: 150 Mg, Unk). The following drugs were being taken at the same time: NA. When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: DyskinesiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyskinesia, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9929333
Angioedema, Rash Pruritic, Eosinophilia, Transaminases Increased, Purpura, Dermatitis Exfoliative, Pyrexia, Red Blood Cell Sedimentation Rate Increased
This Angioedema side effect was reported by a health professional from IN. A 40-year-old male patient (weight:NA) experienced the following symptoms/conditions: post herpetic neuralgia.The patient was prescribed Pregabalin (drug dosage: 75 Mg, 2x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Pregabalin the consumer reported adverse symptoms, such as: Angioedema, Rash Pruritic, Eosinophilia, Transaminases Increased, Purpura, Dermatitis Exfoliative, Pyrexia, Red Blood Cell Sedimentation Rate IncreasedThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9925237
Hypoventilation, Sinus Tachycardia, Euphoric Mood
This is a report of a 23-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: neuralgia, who was treated with Pregabalin (dosage: 50 Mg, 1x/day, start time:
Feb 10, 2014), combined with: NA. and developed a serious reaction and side effect(s): Hypoventilation, Sinus Tachycardia, Euphoric Mood after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in female patients, resulting in Hypoventilation side effect.
Pregabalin Side Effect Report#9925216
Intentional Overdose, Suicidal Ideation, Affective Disorder, Depressed Mood, Hallucination, Visual, Aggression, Anxiety
This report suggests a potential Pregabalin Intentional Overdose side effect(s) that can have serious consequences. A 34-year-old male patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: NA and used Pregabalin (dosage: 15.600 Mg, Day (overall 1.780 Mg/day)) starting NS. After starting Pregabalin the patient began experiencing various side effects, including: Intentional Overdose, Suicidal Ideation, Affective Disorder, Depressed Mood, Hallucination, Visual, Aggression, AnxietyAdditional drugs used concurrently: NA. Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Intentional Overdose, may still occur.
Pregabalin Side Effect Report#9921352
Multi-organ Disorder, Renal Failure, Hepatotoxicity, Transaminases Increased, Blood Pressure Systolic Increased
This Multi-organ Disorder problem was reported by a health professional from US. A 84-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 01, 2013 this consumer started treatment with Pregabalin (dosage: NA). The following drugs were being taken at the same time: NA. When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: Multi-organ Disorder, Renal Failure, Hepatotoxicity, Transaminases Increased, Blood Pressure Systolic IncreasedThe 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 Multi-organ Disorder, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9917624
Pulmonary Oedema
This Pulmonary Oedema side effect was reported by a physician from GR. A 11-year-old female patient (weight:NA) experienced the following symptoms/conditions: partial seizures.The patient was prescribed Pregabalin (drug dosage: 10 Mg/kg, Unk), which was initiated on 201304. Concurrently used drugs:
  • Keppra (5.5 Ml, 2x/day)
  • Vimpat (100 Mg, 2x/day)
  • Frisium (5 Mg, 2x/day)
.After starting to take Pregabalin the consumer reported adverse symptoms, such as: Pulmonary OedemaThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9916055
Delirium, Mental Status Changes, Confusional State, Feeling Abnormal
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Pregabalin (dosage: NA, start time:
Apr 10, 2013), combined with: NA. and developed a serious reaction and side effect(s): Delirium, Mental Status Changes, Confusional State, Feeling Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in male patients, resulting in Delirium side effect.
Pregabalin Side Effect Report#9914144
Off Label Use, Withdrawal Syndrome, Nausea, Crying, Depression, Feeling Of Despair, Tachycardia, Hypertension
This report suggests a potential Pregabalin Off Label Use side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: breast cancer metastatic and used Pregabalin (dosage: 300 Mg, 3x/day) starting
Jan 03, 2014. After starting Pregabalin the patient began experiencing various side effects, including: Off Label Use, Withdrawal Syndrome, Nausea, Crying, Depression, Feeling Of Despair, Tachycardia, HypertensionAdditional drugs used concurrently:
  • Omeprazol (20 Mg, 1x/day)
  • Oxycodone (120 Mg, 1x/day)
  • Ibuprofen (600 Mg, 3x/day)
  • Ramipril (5 Mg, 2x/day)
The patient was hospitalized. Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Off Label Use, may still occur.
Pregabalin Side Effect Report#9910370
Encephalopathy, Myoclonus, Confusional State, Speech Disorder, Hallucination, Visual
This Encephalopathy problem was reported by a health professional from BE. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: neuralgia. On NS this consumer started treatment with Pregabalin (dosage: 75 Mg, Daily, For 9 Days). The following drugs were being taken at the same time: NA. When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: Encephalopathy, Myoclonus, Confusional State, Speech Disorder, Hallucination, VisualThe 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 Encephalopathy, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9869823
Dizziness
This Dizziness side effect was reported by a pharmacist from US. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pregabalin (drug dosage: NA), which was initiated on
Mar 22, 2013. Concurrently used drugs: NA..After starting to take Pregabalin the consumer reported adverse symptoms, such as: DizzinessThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9849407
Off Label Use, Hallucination, Mental Disorder, Pre-existing Condition Improved, Therapeutic Response Unexpected
This is a report of a 62-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: erythromelalgia,pain, who was treated with Pregabalin (dosage: 150 Mg/ Day, start time: NS), combined with:
  • Durotep (Unk)
  • Fentanyl (Unk)
and developed a serious reaction and side effect(s): Off Label Use, Hallucination, Mental Disorder, Pre-existing Condition Improved, Therapeutic Response Unexpected after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in female patients, resulting in Off Label Use side effect.
Pregabalin Side Effect Report#9840599
Local Swelling, Local Swelling, Insomnia, Dizziness, Feeling Of Body Temperature Change
This report suggests a potential Pregabalin Local Swelling side effect(s) that can have serious consequences. A 75-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: neuropathy peripheral,blood cholesterol increased and used Pregabalin (dosage: 150 Mg,(75mg X 2) 2x/day) starting 201312. After starting Pregabalin the patient began experiencing various side effects, including: Local Swelling, Local Swelling, Insomnia, Dizziness, Feeling Of Body Temperature ChangeAdditional drugs used concurrently:
  • Crestor (Unk)
Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Local Swelling, may still occur.
Pregabalin Side Effect Report#9832585
Insomnia, Oropharyngeal Pain, Cough, Paraesthesia, Dyspnoea, Incontinence
This Insomnia problem was reported by a physician from GB. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 11, 2013 this consumer started treatment with Pregabalin (dosage: Unk). The following drugs were being taken at the same time:
  • Esomeprazole (Unk)
  • Alendronic Acid (Unk)
  • Anastrozole (Unk)
  • Losartan (Unk)
  • Paracetamol (Unk)
  • Viscotears (Unk)
  • Nitrofurantoin (Unk)
  • Domperidone (Unk)
When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: Insomnia, Oropharyngeal Pain, Cough, Paraesthesia, Dyspnoea, IncontinenceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Insomnia, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9805785
Completed Suicide
This Completed Suicide side effect was reported by a pharmacist from US. A 53-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Pregabalin (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Citalopram (Unk)
  • Fluoxetine (Unk)
.After starting to take Pregabalin the consumer reported adverse symptoms, such as: Completed SuicideThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9805780
Completed Suicide, Cardiac Arrest, Respiratory Arrest
This is a report of a 50-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Pregabalin (dosage: Unk, start time: NS), combined with:
  • Estrogens Conjugated (Unk)
  • Citalopram (Unk)
  • Acetaminophen (Unk)
  • Lisinopril (Unk)
  • Tramadol (Unk)
  • Diclofenac (Unk)
and developed a serious reaction and side effect(s): Completed Suicide, Cardiac Arrest, Respiratory Arrest after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in female patients, resulting in Completed Suicide side effect.
Pregabalin Side Effect Report#9805772
Completed Suicide, Cardiac Arrest, Respiratory Arrest
This report suggests a potential Pregabalin Completed Suicide side effect(s) that can have serious consequences. A 30-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Pregabalin (dosage: Unk) starting NS. After starting Pregabalin the patient began experiencing various side effects, including: Completed Suicide, Cardiac Arrest, Respiratory ArrestAdditional drugs used concurrently:
  • Amitriptyline (Unk)
  • Nortriptyline (Unk)
  • Zolpidem (Unk)
Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Completed Suicide, may still occur.
Pregabalin Side Effect Report#9805757
Completed Suicide, Cardiac Arrest, Respiratory Arrest
This Completed Suicide problem was reported by a pharmacist from US. A 30-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Pregabalin (dosage: Unk). The following drugs were being taken at the same time:
  • Phenytoin (Unk)
  • Folic Acid (Unk)
  • Azithromycin (Unk)
  • Topiramate (Unk)
  • Lacosamide (Unk)
When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: Completed Suicide, Cardiac Arrest, Respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Completed Suicide, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9804123
Hallucination, Visual, Depersonalisation, Thinking Abnormal, Self-injurious Ideation
This Hallucination, Visual side effect was reported by a physician from GB. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: back pain.The patient was prescribed Pregabalin (drug dosage: 450mg Daily), which was initiated on
May 19, 2010. Concurrently used drugs:
  • Co-codamol (8/500 (ongoing))
.After starting to take Pregabalin the consumer reported adverse symptoms, such as: Hallucination, Visual, Depersonalisation, Thinking Abnormal, Self-injurious IdeationThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9782972
Self Injurious Behaviour
This is a report of a 21-year-old male patient (weight: NA) from IN, suffering from the following health symptoms/conditions: back pain, who was treated with Pregabalin (dosage: 75 Mg, O.d. At Bed Time, start time: NS), combined with:
  • Diclofenac (Unk)
and developed a serious reaction and side effect(s): Self Injurious Behaviour after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in male patients, resulting in Self Injurious Behaviour side effect.
Pregabalin Side Effect Report#9779559
Convulsion, Vertigo
This report suggests a potential Pregabalin Convulsion side effect(s) that can have serious consequences. A 24-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: arthralgia and used Pregabalin (dosage: 75 Mg, 2x/day) starting
Jun 11, 2013. After starting Pregabalin the patient began experiencing various side effects, including: Convulsion, VertigoAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Pregabalin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Pregabalin Side Effect Report#9778494
Lethargy, Respiratory Depression, Hypercapnia
This Lethargy problem was reported by a pharmacist from US. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On
Dec 03, 2013 this consumer started treatment with Pregabalin (dosage: NA). The following drugs were being taken at the same time: NA. When using Pregabalin, the patient experienced the following unwanted symptoms/side effects: Lethargy, Respiratory Depression, HypercapniaThe 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 Lethargy, may become evident only after a product is in use by the general population.
Pregabalin Side Effect Report#9753069
Intentional Overdose, Liver Function Test Abnormal, Psychomotor Retardation, Speech Disorder
This Intentional Overdose side effect was reported by a physician from DE. A 33-year-old female patient (weight:NA) experienced the following symptoms/conditions: euphoric mood.The patient was prescribed Pregabalin (drug dosage: 1500 Mg, In One Day), which was initiated on 201007. Concurrently used drugs:
  • Polamidon (8 Ml, Unk)
.After starting to take Pregabalin the consumer reported adverse symptoms, such as: Intentional Overdose, Liver Function Test Abnormal, Psychomotor Retardation, Speech DisorderThese side effects may potentially be related to Pregabalin.
Pregabalin Side Effect Report#9749694
Liver Function Test Abnormal
This is a report of a 36-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Pregabalin (dosage: Unk, start time: 2011), combined with:
  • Nexplanon (68 Mg, Unk)
and developed a serious reaction and side effect(s): Liver Function Test Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pregabalin treatment in female patients, resulting in Liver Function Test Abnormal side effect. The patient was hospitalized.


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The appearance of Pregabalin 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 Pregabalin Side Effects for Women?

Women Side Effects Reports
Completed Suicide 45
Respiratory Arrest 31
Cardiac Arrest 30
Confusional State 29
Dizziness 25
Somnolence 20
Liver Function Test Abnormal 18
Death 17
Oedema Peripheral 17
Tremor 17

What are common Pregabalin Side Effects for Men?

Men Side Effects Reports
Convulsion 24
Confusional State 23
Cardiac Arrest 21
Somnolence 17
Withdrawal Syndrome 17
Completed Suicide 16
Dizziness 16
Cardiac Failure 15
Respiratory Arrest 15
Rhabdomyolysis 14

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.

    Pregabalin 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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