Lyrica Cr (pregabalin)

No dosing information is available for this tab.

Pregabalin is administered orally as conventional (immediate-release) capsules or oral solution. The drug also is available as extended-release tablets for the treatment of postherpetic neuralgia (PHN) or diabetic peripheral neuropathy (DPN) in adults; efficacy of this preparation has not been established for other indications. Pregabalin capsules and oral solution are administered orally without regard to food; the extended-release tablets should be administered once daily after the evening meal. The extended-release tablets should be swallowed whole and not split, crushed, or chewed.

When switching from conventional preparations of pregabalin to the extended-release tablets, patients should take their usual morning dose of conventional capsules or oral solution, and initiate therapy with the extended-release tablets after the evening meal. The appropriate dose conversion should be performed according to the table below (see Table 1).

Table 1. Dose Conversion from Conventional to Extended-release Pregabalin

Conventional Pregabalin Total Daily Extended-release Pregabalin Dose Dose 75 mg daily (given 2 or 3 times 82.5 mg once daily daily) 150 mg daily (given 2 or 3 times 165 mg once daily daily) 225 mg daily (given 2 or 3 times 247.5 mg once daily daily) 300 mg daily (given 2 or 3 times 330 mg once daily daily) 450 mg daily (given 2 or 3 times 495 mg once daily daily) 600 mg daily (given 2 or 3 times 660 mg once daily daily)

When discontinuing therapy, pregabalin should be withdrawn gradually by tapering the dosage over at least 1 week. (See Discontinuance of Therapy under Cautions: Warnings/Precautions.)

Patients currently receiving or beginning therapy with pregabalin and/or any other anticonvulsant for any indication should be closely monitored for the emergence or worsening of depression, suicidal thoughts or behavior (suicidality), and/or any unusual changes in mood or behavior. (See Suicidality Risk under Cautions: Warnings/Precautions.)

Specific drug interaction studies conducted with pregabalin extended-release tablets are limited; the information presented below is derived principally from studies with conventional preparations of pregabalin. Similar pharmacokinetic interactions are expected with the various preparations of pregabalin.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Agents That May Cause Respiratory Depression/Sodium Oxybate

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Oxybate by itself may be associated with severe somnolence or respiratory depression. Concurrent use with other CNS depressants may further increase the risk for respiratory depression or loss of consciousness.(1-3)

CLINICAL EFFECTS: Concurrent use of sodium oxybate and sedative hypnotics or alcohol may further increase the risk for profound sedation, respiratory depression, coma, and/or death.(1,2) Fatalities have been reported.(3)

PREDISPOSING FACTORS: Based upon FDA evaluation of deaths in patients taking sodium oxybate, risk factors may include: use of multiple drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Note that in oxybate clinical trials for narcolepsy 78% - 85% of patients were also receiving concomitant CNS stimulants.(1-3)

PATIENT MANAGEMENT: Avoid use of concomitant opioids, benzodiazepines, sedating antidepressants, sedating antipsychotics, general anesthetics, or muscle relaxants, particularly when predisposing risk factors are present. If combination use is required, dose reduction or discontinuation of one or more CNS depressants should be considered. If short term use of an opioid or general anesthetic is required, consider interruption of sodium oxybate treatment.(1,2) Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. Consider these risks when using concurrently with other agents that may cause CNS depression.(4) Discuss opioid reversal agents (e.g., naloxone, nalmefene) with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing an opioid reversal agent (e.g., naloxone, nalmefene) to patients prescribed medicines to treat OUD or opioid analgesics who are at increased risk of opioid overdose (such as those taking CNS depressants) and when a patient has household members/close contacts at risk for accidental overdose. Discuss the options for obtaining an opioid reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program).(5)

DISCUSSION: The FDA evaluated sodium oxybate postmarket fatal adverse event reports from the FDA Adverse Event Reporting System(AERS)and from the manufacturer. Although report documentation was not always optimal or complete, useful information was obtained. Factors which may have contributed to fatal outcome: concomitant use of one or more drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Many deaths occurred in patients with serious psychiatric disorders such as depression and substance abuse. Other concomitant diseases may have also contributed to respiratory and CNS depressant effects of oxybate.(3)

Gabapentinoids/Opioids (Cough & Cold)

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Opioid-induced reduction in GI motility may increase the absorption of gabapentin and pregabalin.(1) Gabapentin and pregabalin may reverse opioid-induced tolerance of respiratory depression.(2) Concurrent use may result in profound sedation, respiratory depression, coma, and/or death.(3)

CLINICAL EFFECTS: Concurrent use of opioids may result in elevated levels of and toxicity from gabapentin and pregabalin, including profound sedation, respiratory depression, coma, and/or death.(1-7)

PREDISPOSING FACTORS: Patients who are elderly, are taking other CNS depressants, have decreased renal function, and/or have conditions that reduce lung function (e.g. Chronic Obstructive Pulmonary Disease [COPD]) may be at a higher risk of this interaction.

PATIENT MANAGEMENT: Avoid prescribing opioid-including cough medications for patients taking CNS depressants.(8) If concurrent use is necessary, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. If starting a gabapentinoid with an opioid analgesic, prescribe a lower initial dose of the gabapentinoid than indicated in the absence of an opioid and titrate based upon clinical response. If an opioid analgesic is indicated in a patient already taking a gabapentinoid, prescribe a lower dose of the opioid and titrate based upon clinical response.(1) Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. Consider these risks when using concurrently with other agents that may cause CNS depression.(9) Monitor patients receiving concurrent therapy for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.(1) Discuss opioid reversal agents (e.g., naloxone, nalmefene) with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing an opioid reversal agent (e.g., naloxone, nalmefene) to patients prescribed medicines to treat OUD or opioid analgesics who are at increased risk of opioid overdose (such as those taking CNS depressants) and when a patient has household members/close contacts at risk for accidental overdose. Discuss the options for obtaining an opioid reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program).(9)

DISCUSSION: In a study in 12 healthy males, administration of a single dose of morphine (60 mg sustained release) increased the area-under-curve (AUC) of a single dose of gabapentin (600 mg) by 44%.(1,3,4) There were no affects on the pharmacokinetics of morphine.(1,3,4) The combination of gabapentin plus morphine increased pain tolerance over the combination of morphine plus placebo. Side effects were not significantly different between morphine plus placebo and morphine plus gabapentin.(1) A retrospective, case-control study of opioid users in Ontario, Canada between August 1, 1997 and December 31, 2013 who died of an opioid-related cause matched cases to up to 4 controls who also used opioids. Use of gabapentin in the 120 days prior to death resulted in a significant increase in odds of opioid-related death (OR 1.99, CI=1.61-2.47, p<0.001), compared to opioid use alone. Use of moderate dose (900 mg to 1,799 mg daily) or high dose (>= 1,800 mg daily) gabapentin increased the odds of opioid-related death 60% compared to opioid use without gabapentin. Review of gabapentin prescriptions from calendar year 2013 found that 46% of gabapentin users received at least 1 opioid prescription.(3) Among 49 case reports submitted to FDA over a 5 year period (2012-2017), 12 people died from respiratory depression with gabapentinoids. Two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals were reviewed. A trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. Three observational studies showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after surgery. Several animal studies also showed that pregabalin plus opioids can depress respiratory function.(7) A retrospective cohort study evaluated the risk of mortality among Medicare beneficiaries aged 65 and older who were taking gabapentin with or without concurrent use of opioids. All-cause mortality in gabapentin users compared to duloxetine users was 12.16 per 1,000 person years vs. 9.94 per 1,000 person years, respectively. Adjusted for covariates, the risk of all-cause mortality among gabapentin users on high-dose opioids was more than double the control group (hazard ratio (HR) 2.03, CI=1.19-3.46).(10)

Myelosuppressives; Immunomodulators/Sodium Iodide I 131

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1)

CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1)

DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Gabapentinoids/Benzodiazepines

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Concurrent use may result in profound sedation, respiratory depression, coma, and/or death.(1-3)

CLINICAL EFFECTS: Concurrent use of benzodiazepines may result in elevated levels of and toxicity from gabapentin and pregabalin, including profound sedation, respiratory depression, coma, and/or death.(1-3)

PREDISPOSING FACTORS: Patients who are elderly, are taking other CNS depressants, have decreased renal function, and/or have conditions that reduce lung function (e.g. Chronic Obstructive Pulmonary Disease [COPD]) may be at a higher risk of this interaction.

PATIENT MANAGEMENT: Limit prescribing benzodiazepines and gabapentinoids to patients for whom alternatives are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.(1) If concurrent use is necessary, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. If starting a gabapentinoid with an benzodiazepine, prescribe a lower initial dose of the gabapentinoid than indicated in the absence of an opioid and titrate based upon clinical response. If a benzodiazepine is indicated (other than an indication of epilepsy) in a patient already taking a gabapentinoid, prescribe a lower dose of the benzodiazepine and titrate based upon clinical response.(1) Monitor patients receiving concurrent therapy for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.(1)

DISCUSSION: Clinical trials have shown no pharmacokinetic interaction between pregabalin (300 mg BID) and lorazepam (1 mg single dose).(2) Among 49 case reports submitted to FDA over a 5 year period (2012-2017), 12 people died from respiratory depression with gabapentinoids. Two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals were reviewed. A trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. Three observational studies showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after surgery. Several animal studies also showed that pregabalin plus opioids can depress respiratory function. Benzodiazepines are expected to have a similar effect when used with gabapentinoids.(1)

Gabapentinoids/Muscle Relaxants

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Concurrent use of gabapentinoids and muscle relaxants may result in additive CNS depression.(1)

CLINICAL EFFECTS: Concurrent use of gabapentinoids and other CNS depressants, such as muscle relaxants, may result in profound sedation, respiratory depression, coma, and/or death.(1)

PREDISPOSING FACTORS: Concurrent use of alcohol or other CNS depressants may increase the risk of adverse effects.

PATIENT MANAGEMENT: Limit prescribing muscle relaxants and gabapentinoids to patients for whom alternatives are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.(1) If concurrent use is necessary, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. If starting a gabapentinoid with a muscle relaxant, prescribe a lower initial dose of the gabapentinoid than indicated in the absence of a muscle relaxant and titrate based upon clinical response. If a muscle relaxant is indicated in a patient already taking a gabapentinoid, prescribe a lower dose of the muscle relaxant and titrate based upon clinical response.(1) Monitor patients receiving concurrent therapy for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.(1)

DISCUSSION: Clinical trials have shown no pharmacokinetic interaction between pregabalin and muscle relaxants.(2) Among 49 case reports submitted to FDA over a 5 year period (2012-2017), 12 people died from respiratory depression with gabapentinoids. Two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals were reviewed. A trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. Three observational studies showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after surgery. Several animal studies also showed that pregabalin plus opioids can depress respiratory function. Muscle relaxants are expected to have a similar effect when used with gabapentinoids.(1)

Gabapentinoids/Opioids (Ir & Er)

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Opioid-induced reduction in GI motility may increase the absorption of gabapentin and pregabalin.(1) Gabapentin and pregabalin may reverse opioid-induced tolerance of respiratory depression.(2) Concurrent use may result in profound sedation, respiratory depression, coma, and/or death.(3)

CLINICAL EFFECTS: Concurrent use of opioids may result in elevated levels of and toxicity from gabapentin and pregabalin, including profound sedation, respiratory depression, coma, and/or death.(1-7)

PREDISPOSING FACTORS: Patients who are elderly, are taking other CNS depressants, have decreased renal function, and/or have conditions that reduce lung function (e.g. Chronic Obstructive Pulmonary Disease [COPD]) may be at a higher risk of this interaction.

PATIENT MANAGEMENT: Limit prescribing opioid analgesics and gabapentinoids to patients for whom alternatives are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.(1) If concurrent use is necessary, limit the dosages and duration of each drug to the minimum possible while achieving the desired clinical effect. If starting a gabapentinoid with an opioid analgesic, prescribe a lower initial dose of the gabapentinoid than indicated in the absence of an opioid and titrate based upon clinical response. If an opioid analgesic is indicated in a patient already taking a gabapentinoid, prescribe a lower dose of the opioid and titrate based upon clinical response.(1) Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. Consider these risks when using concurrently with other agents that may cause CNS depression.(8) Monitor patients receiving concurrent therapy for unusual dizziness or lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness.(1) Discuss opioid reversal agents (e.g., naloxone, nalmefene) with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing an opioid reversal agent (e.g., naloxone, nalmefene) to patients prescribed medicines to treat OUD or opioid analgesics who are at increased risk of opioid overdose (such as those taking CNS depressants) and when a patient has household members/close contacts at risk for accidental overdose. Discuss the options for obtaining an opioid reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program).(9)

DISCUSSION: In a study in 12 healthy males, administration of a single dose of morphine (60 mg sustained release) increased the area-under-curve (AUC) of a single dose of gabapentin (600 mg) by 44%.(1,3,4) There were no affects on the pharmacokinetics of morphine.(1,3,4) The combination of gabapentin plus morphine increased pain tolerance over the combination of morphine plus placebo. Side effects were not significantly different between morphine plus placebo and morphine plus gabapentin.(1) A retrospective, case-control study of opioid users in Ontario, Canada between August 1, 1997 and December 31, 2013 who died of an opioid-related cause matched cases to up to 4 controls who also used opioids. Use of gabapentin in the 120 days prior to death resulted in a significant increase in odds of opioid-related death (OR 1.99, CI=1.61-2.47, p<0.001), compared to opioid use alone. Use of moderate dose (900 mg to 1,799 mg daily) or high dose (>= 1,800 mg daily) gabapentin increased the odds of opioid-related death 60% compared to opioid use without gabapentin. Review of gabapentin prescriptions from calendar year 2013 found that 46% of gabapentin users received at least 1 opioid prescription.(3) Among 49 case reports submitted to FDA over a 5 year period (2012-2017), 12 people died from respiratory depression with gabapentinoids. Two randomized, double-blind, placebo-controlled clinical trials in healthy people, three observational studies, and several studies in animals were reviewed. A trial showed that using pregabalin alone and using it with an opioid pain reliever can depress breathing function. Three observational studies showed a relationship between gabapentinoids given before surgery and respiratory depression occurring after surgery. Several animal studies also showed that pregabalin plus opioids can depress respiratory function.(7) A retrospective cohort study evaluated the risk of mortality among Medicare beneficiaries aged 65 and older who were taking gabapentin with or without concurrent use of opioids. All-cause mortality in gabapentin users compared to duloxetine users was 12.16 per 1,000 person years vs. 9.94 per 1,000 person years, respectively. Adjusted for covariates, the risk of all-cause mortality among gabapentin users on high-dose opioids was more than double the control group (hazard ratio (HR) 2.03, CI=1.19-3.46).(10)

Pregabalin/Thiazolidinedione Antidiabetics

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Both pregabalin and thiazolidinedione antidiabetics may cause weight gain and/or fluid retention.(1)

CLINICAL EFFECTS: Concurrent use of pregabalin and thiazolidinedione antidiabetics may result in weight gain and/or fluid retention, which may increase the risk of heart failure in patients with preexisting cardiac conditions.(1)

PREDISPOSING FACTORS: Preexisting cardiac conditions may increase the risk of heart failure.(1)

PATIENT MANAGEMENT: Patients should be monitored for weight gain and/or fluid retention when taking pregabalin with the thiazolidinedione antidiabetics agents together. Congestive heart failure or worsening of existing congestive heart failure may occur.

DISCUSSION: In clinical trials, the incidence of peripheral edema was 3% of patients receiving a thiazolidinedione antidiabetic alone, 8% of patients receiving pregabalin alone, and 19% of patients on combination therapy. The incidence of weight gain was 0% of patients receiving a thiazolidinedione antidiabetic alone, 4% of patients receiving pregabalin alone, and 7.5% of patients on combination therapy.(1)

Known hypersensitivity to pregabalin or any ingredient in the formulation.

There are no contraindication contraindications for this drug.

• Acute decompensated heart failure
• Angioedema
• Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min
• Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min
• Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
• Chronic kidney disease stage 5 (failure) GFr<15 ml/min
• Chronic obstructive pulmonary disease
• Myopathy with CK elevation
• Respiratory depression
• Suicidal ideation

• Atrioventricular block
• Chronic heart failure
• Depression
• Drug abuse
• Drug dependence
• History of drug abuse
• Kidney disease with likely reduction in glomerular filtration rate (GFr)
• Peripheral edema
• Reduced visual acuity
• Weight gain

The most common adverse effects in adults receiving conventional pregabalin preparations across indications in clinical trials (occurring in 5% or more of patients and more frequently than placebo) include dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and abnormal thinking (primarily difficulty with concentration/attention). The most common adverse effects in pediatric patients receiving conventional pregabalin for the treatment of partial seizures (occurring in 5% or more of patients and more frequently than placebo) include somnolence, weight gain, and increased appetite.

The most common adverse effects in adults receiving extended-release pregabalin in clinical studies include dizziness, somnolence, headache, fatigue, peripheral edema, nausea, blurred vision, dry mouth, and weight gain.

Other adverse effects commonly reported in adults receiving conventional pregabalin in combination with other anticonvulsant agents in the management of partial seizures include ataxia, tremor, amnesia, speech disorder, increased appetite, peripheral edema, diplopia, and accidental injury.

Other adverse effects commonly reported in adults receiving conventional pregabalin for the management of PHN include headache, ataxia, constipation, peripheral edema, infection, and pain.

Other adverse effects commonly reported in adults receiving conventional pregabalin for the management of DPN include asthenia and peripheral edema.

Other adverse effects commonly reported in adults receiving conventional pregabalin for the management of fibromyalgia include headache, euphoric mood, attention disturbance, balance disorder, constipation, fatigue, peripheral edema, increased appetite, and sinusitis.

Other adverse effects commonly reported in adults receiving conventional pregabalin for the management of neuropathic pain associated with spinal cord injury include fatigue, peripheral edema, constipation, nasopharyngitis, and muscle weakness.

More Frequent

• Ataxia

Less Frequent

• Facial edema
• Hypoglycemic disorder
• Infection
• Thrombocytopenic disorder

Rare or Very Rare

• Accidental fall
• Angioedema
• Behavioral disorders
• Blistering skin
• Bullous pemphigoid
• Diplopia
• Drug dependence
• Dysarthria
• Dyskinesia
• Heart failure
• Kidney stone
• Prolonged PR interval
• Pulmonary edema
• Respiratory depression
• Suicidal
• Suicidal ideation
• Tinnitus
• Urticaria
• Wheezing

More Frequent

• Blurred vision
• Concentration difficulty
• Disturbance in thinking
• Dizziness
• Drowsy
• Fatigue
• Peripheral edema
• Weight gain
• Xerostomia

Less Frequent

• Accidental injury
• Acute abdominal pain
• Acute cognitive impairment
• Arthralgia
• Back pain
• Constipation
• Erectile dysfunction
• Euphoria
• Gait abnormality
• Gastroenteritis
• General weakness
• Headache disorder
• Hypoesthesia
• Increased appetite
• Memory impairment
• Muscle fasciculation
• Muscle spasm
• Nausea
• Orgasm disorder
• Pruritus of skin
• Sinusitis
• Vertigo

Rare or Very Rare

• Abdominal distension
• Acute bacterial otitis media
• Amenorrhea
• Bronchitis
• Chest pain
• Conjunctivitis
• Cramps in legs
• Depersonalization
• Diarrhea
• Dysmenorrhea
• Dyspareunia
• Dyspnea
• Dysuria
• Ecchymosis
• Edema
• Erythema
• Fever
• Flatulence
• Flu-like symptoms
• Gynecomastia
• Hematuria
• Hyperhidrosis
• Hypertonia
• Increased urinary frequency
• Libido changes
• Muscle weakness
• Myalgia
• Nail disorders
• Nervousness
• Nystagmus
• Skin rash
• Stupor
• Symptoms of anxiety
• Tremor
• Urinary incontinence
• Urinary retention
• Visual changes
• Vomiting

No enhanced messaging available.

Safety and efficacy of pregabalin conventional preparations for adjunctive treatment of partial seizures have not been established in children younger than 1 month of age. Use of conventional pregabalin in older children is supported by evidence from 2 randomized placebo-controlled studies. (See Uses: Seizure Disorders.) Although the youngest patient evaluated in these studies was 3 months of age, use of pregabalin in infants 1-3 months of age can be supported by additional pharmacokinetic data.

Clearance of pregabalin (normalized for body weight) is approximately 40% higher in patients weighing less than 30 kg. For children weighing less than 30 kg, a dosage increase is required to achieve comparable exposure to those weighing 30 kg or more.

Safety and efficacy of pregabalin for the treatment of fibromyalgia, diabetic peripheral neuropathy (DPN), postherpetic neuralgia (PHN), or neuropathic pain associated with spinal cord injury have not been established in pediatric patients.

Safety and efficacy of pregabalin extended-release tablets have not been established in pediatric patients.

Women who are pregnant while receiving pregabalin should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry at 888-233-2334 (for patients); registry information also is available on the website https://www.aedpregnancyregistry.org/.

There are no adequate and well-controlled studies of pregabalin in pregnant women; however, based on animal studies, pregabalin may cause fetal harm. In animal reproductive studies, pregabalin produced developmental toxicity (e.g., fetal structural abnormalities, skeletal malformations, retarded ossification, decreased fetal body weight) when administered orally to pregnant animals during the period of organogenesis at exposure levels 16 times higher than those associated with the maximum recommended human dosage of 600 mg daily. When pregabalin was administered to female rats throughout the period of gestation and lactation, growth retardation, impairment to the nervous and reproductive systems, and decreased survival were observed in the offspring.

Pregabalin is distributed into human milk at steady-state concentrations approximately 76% of those in maternal plasma. Following administration of maternal dosages of 300 mg daily, the estimated average infant dose of pregabalin from breast milk is 0.31 mg/kg daily (approximately 7% of the maternal dose). Because of the potential for tumorigenicity (see Carcinogenicity under Cautions: Warnings/Precautions), breastfeeding is not recommended during pregabalin therapy.

The manufacturer states that no substantial differences in safety and efficacy have been observed in geriatric patients relative to younger adults; however, increased sensitivity to pregabalin in certain individuals cannot be ruled out. In controlled clinical studies of patients with fibromyalgia, neurological adverse reactions including dizziness, blurred vision, balance disorder, tremor, confusional state, abnormal coordination, and lethargy occurred more frequently in patients 65 years of age and older than in younger adults. In addition, FDA warns that geriatric patients receiving gabapentinoids are at increased risk of potentially serious, life-threatening, or fatal respiratory depression; pregabalin therapy should be initiated at the lowest dosage and titrated carefully with close monitoring in such patients.

It should be considered that pregabalin is substantially excreted by the kidneys, and the risk of adverse reactions to the drug may be increased in patients with impaired renal function. The dosage should be adjusted for geriatric patients with renal impairment. Monitoring renal function in geriatric patients may be helpful. (See Dosage and Administration: Special Populations.)