Pregabalin: What is it and why can it be dangerous?

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21 March

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The prescription drug pregabalin has been linked to a number of deaths in the UK and around the world.

Many users buy the drug illegally on the black market, often from unregulated websites.

What is pregabalin and what is it used for?

It comes as tablets, capsules or in liquid form, and may be called Alzain, Axalid or Lyrica, depending on the brand.

More than eight million pregabalin prescriptions were dispensed in England in .

Prescription rates are showing signs of levelling off across the UK, but doctors say it can be a very useful treatment for patients when taken correctly, and should remain available.

What are the side effects of pregabalin?

Some call pregabalin the new Valium or "Bud" (as in Budweiser beer) because it can make users feel relaxed, in a similar way to tranquilisers or alcohol.

Taking too much of it - particularly when combined with other street drugs that also have a sedative effect - can cause drowsiness and breathing problems.

Patients who are prescribed pregabalin are advised to avoid alcohol.

How many deaths have been linked to pregabalin in the UK?

Records in England suggest most deaths between and involving pregabalin happened when it was taken alongside another medicine such as methadone or morphine.

In many cases, the drugs had not been prescribed.

Taken together, opiates and pregabalin slow down breathing. An emergency antidote called naloxone that works against opiates does nothing to counteract pregabalin's effects.

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Taking pregabalin with opioids, such as heroin, can be particularly dangerous

The data for England and Wales lists 441 deaths related to pregabalin.

There have also been a significant number of deaths in Northern Ireland.

According to the latest data from the NI Statistics and Research Agency (Nisra), 71 of the 213 drug-related deaths recorded in mentioned pregabalin on the death certificate.

That compares to one death in , nine in , rising to 77 in before falling back.

The number of deaths linked to pregabalin and the similar drug gabapentin in Scotland peaked in , at 502. This dropped to 472 in , and 367 in .

Can you get addicted to pregabalin?

Pregabalin's calming effect - sometimes described as a "gentle high" - can mean some users underestimate the drug's addictive nature over time.

Dependence on pregabalin is especially dangerous for those with a prior history of drug abuse or addiction.

How can you come off it, and is withdrawal an issue?

Some people find it hard to stop taking pregabalin.

Withdrawal symptoms can include mood changes such as anger and irritability, anxiety and panic as well as physical symptoms like sweating, nausea and chills.

Anyone trying to come off the drug should seek health advice first.

You should not suddenly stop taking pregabalin unless advised by your doctor. The dose is usually reduced over a week or longer.

Is non-prescription pregabalin illegal?

The Misuse of Drugs Act divides drugs into three categories, class A, B and C, according to the harm they cause when misused.

Pregabalin was made a class C drug in . That means it is illegal to possess pregabalin without a valid prescription, or to supply it to others.

Pregabalin seizures in Northern Ireland increased by more than 34% between and

Police Service of Northern Ireland (PSNI) statistics show pregabalin is the fourth most commonly seized drug behind cannabis, cocaine and benzodiazepines.

Between July and June , pregabalin was seized by officers on 804 occasions.

In the following twelve months, that figure rose to 1,081 - an increase of more than 34%.

How is pregabalin used in other countries?

Since being introduced in the US and UK in , pregabalin has spread across the world.

A study published by the medical journal Nature Communications estimates that the number of doses of pregabalin and gabapentin taken daily around the world rose more than fourfold between and .

There has also been a global increase in pregabalin abuse and deaths.

Australia's Annual Overdose Report highlighted 887 deaths linked to pregabalin and gabapentin between and - 93% involving pregabalin.

Official reports suggest pregabalin is also being increasingly abused in Saudi Arabia and Jordan.

In , the United Arab Emirates (UAE) National Rehabilitation Centre said pregabalin and gabapentin were the most commonly abused drugs by under-30s.

Large quantities of illegally-traded pregabalin have been captured in the UAE and Kuwait.

In March, almost three million pills were seized in the UAE. In , Kuwaiti authorities recovered 15 million pregabalin capsules and half a tonne of the drug in powder form.

If you have been affected by addiction, help and support is available at BBC Action Line.

If you live in Northern Ireland, you can also call the 24-hour helpline Lifeline, on 808 .

The following serious adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In all controlled and uncontrolled trials across various patient populations during the premarketing development of pregabalin, more than 10,000 patients have received pregabalin. Approximately 5,000 patients were treated for 6 months or more, over 3,100 patients were treated for 1 year or longer, and over 1,400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading to Discontinuation in All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all adult populations combined, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the pregabalin group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).

Most Common Adverse Reactions in All Controlled Clinical Studies in Adults

In premarketing controlled trials of all adult patient populations combined (including DPN, PHN, and adult patients with partial-onset seizures), dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and "thinking abnormal" (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with pregabalin than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).

Controlled Studies with Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

Adverse Reactions Leading to Discontinuation

In clinical trials in adults with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with pregabalin and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate&#;.

Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

B

ody system Preferred term

75 mg/day [N=77]

%

150 mg/day [N=212]

%

300 mg/day [N=321]

%

600 mg/day [N=369]

%

All PGB* [N=979]

%

Placebo [N=459] %

Body as a whole

Asthenia
4
2
4
7
5
2
Accidental injury
5
2
2
6
4
3
Back pain
0
2
1
2
2
0
Chest pain
4
1
1
2
2
1
Face edema
0
1
1
2
1
0

Digestive system

Dry mouth
3
2
5
7
5
1
Constipation
0
2
4
6
4
2
Flatulence
3
0
2
3
2
1

Metabolic and nutritional disorders

 
 
 
Peripheral edema
4
6
9
12
9
2
Weight gain
0
4
4
6
4
0
Edema
0
2
4
2
2
0
Hypoglycemia
1
3
2
1
2
1

Nervous system 

Dizziness
8
9
23
29
21
5
Somnolence
4
6
13
16
12
3
Neuropathy
9
2
2
5
4
3
Ataxia
6
1
2
4
3
1
Vertigo
1
2
2
4
3
1
Confusion
0
1
2
3
2
1
Euphoria
0
0
3
2
2
0
Incoordination
1
0
2
2
2
0
Thinking abnormal&#;
1
0
1
3
2
0
Tremor
1
1
1
2
1
0
Abnormal gait
1
0
1
3
1
0
Amnesia
3
1
0
2
1
0
Nervousness
0
1
1
1
1
0

Respiratory system 

Dyspnea
3
0
2
2
2
1

Special senses 

Blurry vision&#;
3
1
3
6
4
2
Abnormal vision
1
0
1
1
1
0

* PGB: pregabalin

&#; Thinking abnormal primarily consists of events related to difficulty with concentration/attention

but also includes events related to cognition and language problems and slowed thinking.

&#; Investigator term; summary level term is amblyopia

Controlled Studies in Postherpetic Neuralgia

Adverse Reactions Leading to Discontinuation

In clinical trials in adults with postherpetic neuralgia, 14% of patients treated with pregabalin and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the pregabalin group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

Most Common Adverse Reactions

Table 5 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined pregabalin group for which the incidence was greater in this combined pregabalin group than in the placebo group. In addition, an event is included, even if the incidence in the all pregabalin group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate&#;. Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

 

Table 5. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Postherpetic Neuralgia

Body system Preferred term

75 mg/d [N=84] %

150 mg/d [N=302] %

300 mg/d [N=312] %

600 mg/d [N=154] %

All PGB* [N=852] %

Placebo [N=398] %

Body as a whole 

Infection
14
8
6
3
7
4
Headache
5
9
5
8
7
5
Pain
5
4
5
5
5
4
Accidental injury
4
3
3
5
3
2
Flu syndrome
1
2
2
1
2
1
Face edema
0
2
1
3
2
1

Digestive system

 
Dry mouth
7
7
6
15
8
3
Constipation
4
5
5
5
5
2
Flatulence
2
1
2
3
2
1
Vomiting
1
1
3
3
2
1

Metabolic and nutritional disorders

 
 
Peripheral edema
0
8
16
16
12
4
Weight gain
1
2
5
7
4
0
Edema
0
1
2
6
2
1

Musculoskeletal  system

                          
 
 
 
 
Myasthenia
1
1
1
1
1
0

Nervous system 

Dizziness
11
18
31
37
26
9
Somnolence
8
12
18
25
16
5
Ataxia
1
2
5
9
5
1
Abnormal gait
0
2
4
8
4
1
Confusion
1
2
3
7
3
0
Thinking abnormal&#;
0
2
1
6
2
2
Incoordination
2
2
1
3
2
0
Amnesia
0
1
1
4
2
0
Speech disorder
0
0
1
3
1
0

Respiratory system 

Bronchitis
0
1
1
3
1
1

Special senses

 
Blurry vision&#;
1
5
5
9
5
3
Diplopia
0
2
2
4
2
0
Abnormal vision
0
1
2
5
2
0
Eye Disorder
0
1
1
2
1
0

Urogenital System 

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Urinary Incontinence
0
1
1
2
1
0

*PGB: pregabalin

&#; Thinking abnormal primarily consists of events related to difficulty with

concentration/attention but also includes events related to cognition and language

problems and slowed thinking.

&#; Investigator term; summary level term is amblyopia

Controlled Studies of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients

Adverse Reactions Leading to Discontinuation

Approximately 15% of patients receiving pregabalin and 6% of patients receiving placebo in trials of adjunctive therapy for partial-onset seizures discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the pregabalin group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

Most Common Adverse Reactions

Table 6 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received pregabalin and 294 patients received placebo for up to 12 weeks. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of "mild" or "moderate&#;.

Table 6. Dose-related Adverse Reaction Incidence in Controlled Trials of Adjunctive Therapy for Partial-Onset Seizures in Adult Patients

Body System Preferred Term

150 mg/d [N = 185] %

300 mg/d [N = 90] %

600 mg/d [N = 395] %

All PGB* [N = 670]&#; %

Placebo

[N = 294] %

Body as a Whole

  
Accidental Injury
7
11
10
9
5
Pain
3
2
5
4
3

Digestive System  

Increased Appetite
2
3
6
5
1
Dry Mouth
1
2
6
4
1
Constipation
1
1
7
4
2

Metabolic and Nutritional Disorders

 
 
 
 
Weight Gain
5
7
16
12
1
Peripheral Edema
3
3
6
5
2

Nervous System 

Dizziness
18
31
38
32
11
Somnolence
11
18
28
22
11
Ataxia
6
10
20
15
4
Tremor
3
7
11
8
4
Thinking Abnormal&#;
4
8
9
8
2
Amnesia
3
2
6
5
2
Speech Disorder
1
2
7
5
1
Incoordination
1
3
6
4
1
Abnormal Gait
1
3
5
4
0
Twitching
0
4
5
4
1
Confusion
1
2
5
4
2
Myoclonus
1
0
4
2
0

Special Senses

Blurred Vision§
5
8
12
10
4
Diplopia
5
7
12
9
4
Abnormal Vision
3
1
5
4
1

* PGB: pregabalin

&#; Excludes patients who received the 50 mg dose in Study E1.

&#; Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also

includes events related to cognition and language problems and slowed thinking.

§ Investigator term; summary level term is amblyopia.

Controlled Study of Adjunctive Therapy for Partial-Onset Seizures in Patients 4 to Less Than 17 Years of Age

Adverse Reactions Leading to Discontinuation

Approximately 2.5% of patients receiving pregabalin and no patients receiving placebo in trials of adjunctive therapy for partial-onset seizures discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the adverse reactions leading to discontinuation were somnolence (3 patients), worsening of epilepsy (1 patient), and hallucination (1 patient).

Most Common Adverse Reactions

Table 7 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin-treated patients. Dose-relatedness was defined as an incidence of the adverse event in the 10 mg/kg/day group that was at least 2% greater than the rate in both the placebo and 2.5 mg/kg/day groups. In this study, 201 patients received pregabalin and 94 patients received placebo for up to 12 weeks. A majority of pregabalin-treated patients in the clinical study had adverse reactions with a

maximum intensity of "mild" or "moderate&#;.

Table 7. Dose-related Adverse Reaction Incidence in a Controlled Trial in Adjunctive Therapy for Partial-Onset Seizures in Patients 4 to Less Than 17 Years of Age

Body System Preferred Term

 

2.5 mg/kg/day

a

[N=104] %
 

10 mg/kg/day

b

[N=97] %
 

All PGB [N=201] %

 

Placebo [N=94] %

 
 

Gastrointestinal disorders

Salivary hypersecretion
1
4
2
0
 

Investigations

Weight increased
4
13
8
4
 

Metabolism and nutrition disorders

Increased appetite
7
10
8
4
 

Nervous system disorders

Somnolence
17
26
21
14
 

Abbreviations: N=number of patients; PGB = pregabalin.

a. 2.5 mg/kg/day: Maximum dose 150 mg/day. Includes patients less than 30 kg for whom dose was adjusted to 3.5 mg/kg/day.

b.10 mg/kg/day: Maximum dose 600 mg/day. Includes patients less than 30 kg for whom dose was adjusted to 14 mg/kg/day.

Controlled Study of Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month to Less Than 4 Years of Age

Most Common Adverse Reactions

Table 8 lists all dose-related adverse reactions occurring in at least 2% of all pregabalin-treated patients. Dose-relatedness was defined as an incidence of the adverse event in the 14 mg/kg/day group that was at least 2% greater than the rate in both the placebo and 7 mg/kg/day groups. In this study, 105 patients received pregabalin and 70 patients received placebo for up to 14 days.

Table 8. Dose-related Adverse Reaction Incidence in a Controlled Trial in Adjunctive Therapy for Partial-Onset Seizures in Patients 1 Month to Less Than 4 Years of Age

Body System Preferred Term

7mg/kg/day

[N=71] %

14 mg/kg/day [N=34] %

All PGB [N=105] %

Placebo [N=70] %

 

Nervous system disorders

Somnolence*
13
21
15
9
 

Infections and infestations

Pneumonia
1
9
4
0
 
Viral infection
3
6
4
3
 

Abbreviations: N=number of patients; PGB=pregabalin.

*includes related terms including lethargy, sluggishness, and hypersomnia.

Controlled Studies with Fibromyalgia

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150 to 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 9 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the &#;all pregabalin&#; treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

Table 9. Adverse Reaction Incidence in Controlled Trials in Fibromyalgia

System Organ Class Preferred term
150 mg/d [N=132] %
300 mg/d [N=502] %
450 mg/d [N=505] %
600 mg/d [N=378] %
All PGB* [N=] %
Placebo [N=505] %

Ear and Labyrinth Disorders 

Vertigo
2
2
2
1
2
0
Eye Disorders
 
 
 
 
 
 
Vision blurred
8
7
7
12
8
1

Gastrointestinal Disorders 

Dry mouth
7
6
9
9
8
2
Constipation
4
4
7
10
7
2
Vomiting
2
3
3
2
3
2
Flatulence
1
1
2
2
2
1
Abdominal distension
2
2
2
2
2
1

General Disorders and Administrative Site Conditions 

Fatigue
5
7
6
8
7
4
Edema peripheral
5
5
6
9
6
2
Chest pain
2
1
1
2
2
1
Feeling abnormal
1
3
2
2
2
0
Edema
1
2
1
2
2
1
Feeling drunk
1
2
1
2
2
0

Infections and Infestations

 
 
 
 
 
Sinusitis
4
5
7
5
5
4
Investigations
 
 
 
 
 
Weight increased
8
10
10
14
11
2

Metabolism and Nutrition Disorders 

Increased appetite
4
3
5
7
5
1
Fluid retention
2
3
3
2
2
1

Musculoskeletal and Connective Tissue Disorders 

Arthralgia
4
3
3
6
4
2
Muscle spasms
2
4
4
4
4
2
Back pain
2
3
4
3
3
3

Nervous System Disorders

 
 
 
 
 
Dizziness
23
31
43
45
38
9
Somnolence
13
18
22
22
20
4
Headache
11
12
14
10
12
12
Disturbance in attention
4
4
6
6
5
1
Balance disorder
2
3
6
9
5
0
Memory impairment
1
3
4
4
3
0
Coordination abnormal
2
1
2
2
2
1
Hypoesthesia
2
2
3
2
2
1
Lethargy
2
2
1
2
2
0
Tremor
0
1
3
2
2
0

Psychiatric Disorders

 
 
 
 
 
Euphoric Mood
2
5
6
7
6
1
Confusional state
0
2
3
4
3
0
Anxiety
2
2
2
2
2
1
Disorientation
1
0
2
1
2
0
Depression
2
2
2
2
2
2

Respiratory, Thoracic and Mediastinal Disorders 

Pharyngolaryngeal pain
2
1
3
3
2
2

* PGB: pregabalin

Controlled Studies in Neuropathic Pain Associated with Spinal Cord Injury

Adverse Reactions Leading to Discontinuation

In clinical trials of adults with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

Most Common Adverse Reactions

Table 10 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients for which the incidence was greater than in the placebo treatment group with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of "mild" or "moderate".

Table 10. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Spinal Cord Injury

System Organ Class

Preferred term

PGB* (N=182)

Placebo (N=174)

%

%

Ear and labyrinth disorders

Vertigo
2.7
1.1

Eye disorders

Vision blurred
6.6
1.1

Gastrointestinal disorders

Dry mouth
11.0
2.9
Constipation
8.2
5.7
Nausea
4.9
4.0
Vomiting
2.7
1.1

General disorders and administration site conditions

Fatigue
11.0
4.0
Edema peripheral
10.4
5.2
Edema
8.2
1.1
Pain
3.3
1.1

Infections and infestations

Nasopharyngitis
8.2
4.6

Investigations

Weight increased
3.3
1.1
Blood creatine phosphokinase increased
2.7
0

Musculoskeletal and connective tissue disorders

Muscular weakness
4.9
1.7
Pain in extremity
3.3
2.3
Neck pain
2.7
1.1
Back pain
2.2
1.7
Joint swelling
2.2
0

Nervous system disorders 

Somnolence
35.7
11.5
Dizziness
20.9
6.9
Disturbance in attention
3.8
0
Memory impairment
3.3
1.1
Paresthesia
2.2
0.6
Psychiatric disorders
 
 
Insomnia
3.8
2.9
Euphoric mood
2.2
0.6
Renal and urinary disorders
 
 
Urinary incontinence
2.7
1.1
Skin and subcutaneous tissue disorders
 
 
Decubitus ulcer
2.7
1.1
Vascular disorders
 
 
Hypertension
2.2
1.1
Hypotension
2.2
0

* PGB: Pregabalin

Other Adverse Reactions Observed During the Clinical Studies of pregabalin

Following is a list of treatment-emergent adverse reactions reported by patients treated with pregabalin during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/ patients; rare reactions are those occurring in fewer than 1/ patients. Events of major clinical importance are described in the Warnings and Precautions section (5).

Body as a Whole &#; Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

Cardiovascular System &#; Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

Digestive System &#; Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

Hemic and Lymphatic System &#; Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia, Alanine aminotransferase increased, Aspartate aminotransferase increased

Metabolic and Nutritional Disorders &#; Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal System &#; Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent: Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

Nervous System &#; Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia; Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barré syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

Respiratory System &#; Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

Skin and Appendages &#; Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

Special senses &#; Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

Urogenital System &#; Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

Comparison of Gender and Race

The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

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