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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] • Hypoglycemia [see Warnings and Precautions ( 5.4 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.5 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] • Diabetic Retinopathy Complications in Patients with Type 2 Diabetes [see Warnings and Precautions ( 5.8 )] • Heart Rate Increase [see Warnings and Precautions ( 5.9 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.10 )] Most common adverse reactions (incidence ≥5%) in adults or pediatric patients aged 12 years and older are: nausea, diarrhea, vomiting, constipation, abdominal pain, dysesthesia, headache, fatigue, dyspepsia, dizziness, abdominal distension, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, gastroesophageal reflux disease, and hair loss. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-833-934-6891 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials in Adults with Obesity or Overweight for Weight Reduction WEGOVY 2.4 mg Subcutaneous Injection Weekly Dosage WEGOVY was evaluated for safety in 3 randomized, double-blind, placebo-controlled trials that included 2,116 adult patients with obesity or overweight treated with 2.4 mg WEGOVY injection for up to 68 weeks and a 7-week off-drug follow-up period [see Clinical Studies ( 14.2 )] . Baseline characteristics included a mean age of 48 years, 71% female, 72% White, 14% Asian, 9% Black or African American, and 5% reported as other or unknown; and 85% were not Hispanic or Latino ethnicity, 13% were Hispanic or Latino ethnicity, and 2% reported as unknown. The baseline characteristics were 42% with hypertension, 19% with type 2 diabetes, 43% with dyslipidemia, 28% with a BMI greater than 40 kg/m 2 and 4% with CV disease. In these clinical trials, 6.8% of patients treated with 2.4 mg WEGOVY injection and 3.2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were nausea (1.8% versus 0.2%), vomiting (1.2% versus 0%), and diarrhea (0.7% versus 0.1%) for WEGOVY and placebo, respectively. Table 3 shows adverse reactions reported in greater than or equal to 2% of WEGOVY 2.4 mg injection-treated adult patients and more frequently than in the placebo group from these trials. Table 3. Adverse Reactions (≥2% and Greater Than Placebo) in WEGOVY 2.4 mg Injection-treated Adults with Obesity or Overweight for Weight Reduction Placebo N=1,261 % WEGOVY Injection (2.4 mg Once Weekly) N=2,116 % Nausea 16 44 Diarrhea 16 30 Vomiting 6 24 Constipation 11 24 Abdominal Pain a 10 20 Headache 10 14 Fatigue b 5 11 Dyspepsia 3 9 Dizziness 4 8 Abdominal Distension 5 7 Eructation <1 7 Hypoglycemia in T2DM c 2 6 Flatulence 4 6 Gastroenteritis 4 6 Gastroesophageal Reflux Disease 3 5 Gastritis d 1 4 Gastroenteritis Viral 3 4 Hair Loss 1 3 Dysesthesia e 1 2 a Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort and epigastric discomfort. b Includes fatigue and asthenia. c Defined as blood glucose <54 mg/dL with or without symptoms of hypoglycemia or severe hypoglycemia (requiring the assistance of another person) in patients with type 2 diabetes not on concomitant insulin (Study 3, WEGOVY N=403, Placebo N=402). See text below for further information regarding hypoglycemia in patients with and without type 2 diabetes. T2DM = type 2 diabetes mellitus. d Includes chronic gastritis, gastritis, gastritis erosive, and reflux gastritis. e Includes paresthesia, hyperesthesia, burning sensation, allodynia, dysesthesia, skin burning sensation, pain of skin, and sensitive skin. CV Outcomes Trial In a CV outcomes trial, 8,803 patients were exposed to WEGOVY injection for a median of 37.3 months and 8,801 patients were exposed to placebo for a median of 38.6 months [see Clinical Studies ( 14.1 )] . Safety data collection was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest. Sixteen percent (16%) of WEGOVY injection-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event. Additional information from this trial is included in subsequent sections below when relevant. WEGOVY 7.2 mg Subcutaneous Injection Weekly Dosage The safety of WEGOVY 7.2 mg injection was evaluated in two 72-week double-blinded randomized placebo-controlled 3-armed trials (Study 8 and Study 9), including 1,311 patients with obesity (BMI ≥30 kg/m 2 ) exposed in the treatment arm with WEGOVY 7.2 mg injection, 304 patients exposed in the treatment arm with WEGOVY 2.4 mg injection, and 303 patients exposed to placebo [see Clinical Studies ( 14.2 )] . After dosage escalation, 1,149 patients received at least one dose of WEGOVY 7.2 mg injection, and 578 patients received 7.2 mg for at least 1 year. Baseline characteristics in the WEGOVY 7.2 mg injection arm included a mean age of 49 years, 70% female, 85% White, 5% Asian, 8% Black or African American, and 2% reported as other or unknown; and 5% were Hispanic or Latino ethnicity. At baseline, mean BMI was 39.5 kg/m 2 , 52% with hypertension, 38% with dyslipidemia, 40% with a BMI greater than 40 kg/m 2 , and 14% with CV disease. In these clinical trials, 5% of patients treated with 7.2 mg WEGOVY injection, 5% of patients treated with 2.4 mg of WEGOVY injection and 2% of patients treated with placebo permanently discontinued treatment as a result of adverse reactions. The most common adverse reactions leading to discontinuation were gastrointestinal disorders: 3%, 3%, and 0.3%, for WEGOVY 7.2 mg injection, WEGOVY 2.4 mg injection, and placebo, respectively. Table 4 shows adverse reactions reported in greater than or equal to 2% of WEGOVY 7.2 mg injection and more frequently than 2.4 mg injection-treated and placebo-treated patients from these studies. Table 4. Adverse Reactions (2% and Greater Than WEGOVY 2.4 mg and Placebo) in WEGOVY 7.2 mg Injection-treated Adults with Obesity for Weight Reduction Placebo N=303 % WEGOVY Injection (2.4 mg Once Weekly) N=304 % WEGOVY Injection (7.2 mg Once Weekly) N=1,311 % Nausea 13 35 39 Vomiting 6 16 22 Dysesthesia a 0 6 22 Constipation 8 19 20 Abdominal pain b 7 9 12 Fatigue c 5 9 11 Headache 7 8 9 Dizziness d 1 5 6 Hair loss 1 3 6 Flatulence 2 2 4 a Includes allodynia, burning sensation, dysesthesia, hyperesthesia, hyperpathia, pain of skin, paresthesia, sensitive skin, skin burning sensation, skin discomfort, and skin sensitization. b Includes abdominal pain, abdominal pain upper, abdominal pain lower, gastrointestinal pain, abdominal tenderness, abdominal discomfort and epigastric discomfort. c Includes fatigue and asthenia. d Includes dizziness and dizziness postural. WEGOVY Tablet 25 mg Oral Daily Dosage WEGOVY tablet was evaluated for safety in a randomized, double-blind, placebo-controlled trial that included 204 adult patients with obesity or overweight and at least one weight-related comorbidity, treated with WEGOVY 25 mg tablets for up to 64 weeks and a 7-week off drug follow-up period (Study 7) [see Clinical Studies ( 14.2 )] . Patients with type 2 diabetes mellitus were excluded. Baseline characteristics included a mean age of 48 years, 76% were female, 93% were White, 0.5% were Asian, 6% were Black or African American, and 8% were Hispanic or Latino ethnicity. Mean baseline body weight was 106.4 kg and mean BMI was 37.5 kg/m 2 . The baseline characteristics were 44% with hypertension, 31% with dyslipidemia, 27% with a BMI greater than 40 kg/m 2 and 1.5% with coronary artery disease. In the clinical trial, 6.9% of patients treated with WEGOVY 25 mg tablets and 5.9% patients treated with placebo permanently discontinued treatment as a result of adverse reactions. The most common event type leading to discontinuation was gastrointestinal adverse reactions reported in 3.4% with WEGOVY tablets and 2% with placebo. In the clinical trial with WEGOVY 25 mg tablets, the types and frequency of common adverse reactions were similar to those listed in Table 3 . Adverse Reactions in a Clinical Trial of Pediatric Patients Aged 12 Years and Older with Obesity Treated with WEGOVY 2.4 mg Injection for Weight Reduction WEGOVY injection was evaluated in a 68-week, double-blind, randomized, parallel group, placebo-controlled, multi-center trial in 201 pediatric patients aged 12 years and older with obesity [see Clinical Studies ( 14.3 )] . Baseline characteristics included a mean age of 15.4 years; 38% of patients were male; 79% were White, 8% were Black or African American, 2% were Asian, and 11% were of other or unknown race; and 11% were of Hispanic or Latino ethnicity. The mean baseline body weight was 107.5 kg, and mean BMI was 37 kg/m 2 . Table 5 shows adverse reactions reported in greater than or equal to 3% of WEGOVY injection-treated pediatric patients and more frequently than in the placebo group from a trial in pediatric patients aged 12 years and older. Table 5. Adverse Reactions (≥3% and Greater than Placebo) in WEGOVY 2.4 mg Injection-treated Pediatric Patients Aged 12 Years and Older with Obesity for Weight Reduction Placebo N=67 % WEGOVY Injection (2.4 mg Once Weekly) N=133 % Nausea 18 42 Vomiting 10 36 Diarrhea 19 22 Headache 16 17 Abdominal Pain 6 15 Nasopharyngitis 10 12 Dizziness 3 8 Gastroenteritis 3 7 Constipation 2 6 Gastroesophageal Reflux Disease 2 4 Sinusitis 2 4 Urinary tract infection 2 4 Ligament sprain 2 4 Anxiety 2 4 Hair Loss 0 4 Cholelithiasis 0 4 Eructation 0 4 Influenza 0 3 Rash 0 3 Urticaria 0 3 Adverse Reactions in Clinical Trials in Adults with MASH Treated with WEGOVY Injection The safety of WEGOVY injection was evaluated in a randomized, double-blind, placebo-controlled trial (Study 11) that included 1,195 adult patients with MASH, including 800 patients who were exposed to WEGOVY for a median of 95.3 weeks and 395 patients who were exposed to placebo for a median of 83.1 weeks [see Clinical Studies ( 14.4 )]. The most commonly reported adverse reactions were consistent with the other approved WEGOVY indications (see Table 3 ). There is limited information in patients with MASH and a BMI <25 kg/m 2 . Additional information from the MASH trial is included in subsequent sections when notable. Unless indicated, the incidence of the adverse reactions in MASH patients was similar to other approved indications. Other Adverse Reactions in Adults and/or Pediatric Patients Treated with WEGOVY Injection or WEGOVY Tablets The safety of WEGOVY tablets and WEGOVY 7.2 mg injection have not been established in pediatric patients or patients with MASH. Acute Gallbladder Disease In WEGOVY clinical trials in adults for weight reduction, cholelithiasis was reported by 1.6% of WEGOVY injection-treated patients and 0.7% of placebo-treated patients and by 2.5% of WEGOVY tablet-treated patients and 1% of placebo tablet-treated patients. Cholecystitis was reported by 0.6% of WEGOVY injection-treated adult patients and 0.2% of placebo-treated patients. In a clinical trial in pediatric patients aged 12 years and older for weight reduction [see Clinical Studies ( 14.3 )] , cholelithiasis was reported by 3.8% of WEGOVY injection-treated patients and 0% placebo-treated patients. Cholecystitis was reported by 0.8% of WEGOVY injection-treated pediatric patients and 0% placebo-treated patients. Hypoglycemia Patients with Type 2 Diabetes In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m 2 for weight reduction, clinically significant hypoglycemia (defined as a plasma glucose less than 54 mg/dL) was reported in 6.2% of WEGOVY injection-treated patients versus 2.5% of placebo-treated patients. A higher rate of clinically significant hypoglycemic episodes was reported with WEGOVY injection (semaglutide 2.4 mg) versus semaglutide 1 mg injection (10.7 vs. 7.2 episodes per 100 patient years of exposure, respectively); the rate in the placebo-treated group was 3.2 episodes per 100 patient years of exposure. In addition, one episode of severe hypoglycemia requiring intravenous glucose was reported in a WEGOVY injection-treated patient versus none in placebo-treated patients. The risk of hypoglycemia was increased when WEGOVY was used with a sulfonylurea. In a glycemic control trial evaluating a dose comparable to the 9 mg and 25 mg semaglutide tablet dose in patients with type 2 diabetes not on insulin, clinically significant hypoglycemia was reported in similar proportions of subjects in both treatment groups. Patients without Type 2 Diabetes Episodes of hypoglycemia have been reported with GLP-1 receptor agonists in adult patients without type 2 diabetes mellitus. In WEGOVY clinical trials in adult patients without type 2 diabetes mellitus for weight reduction, there was no systematic capturing or reporting of hypoglycemia. In a CV outcomes trial in adult patients without type 2 diabetes, 3 episodes of serious hypoglycemia were reported in WEGOVY injection-treated patients versus 1 episode in placebo. Patients with a history of bariatric surgery (a risk factor for hypoglycemia) had more events of serious hypoglycemia while taking WEGOVY injection (2.3%, 2/87) than placebo (0%, 0/97). Retinal Disorders in Patients with Type 2 Diabetes In a trial of adult patients with type 2 diabetes and BMI greater than or equal to 27 kg/m 2 for weight reduction, retinal disorders were reported by 6.9% of patients treated with WEGOVY injection (semaglutide 2.4 mg), 6.2% of patients treated with semaglutide 1 mg, and 4.2% of patients treated with placebo. The majority of events were reported as diabetic retinopathy (4%, 2.7%, and 2.7%, respectively) and non-proliferative retinopathy (0.7%, 0%, and 0%, respectively). In a glycemic control trial evaluating the 9 mg and 25 mg semaglutide tablet doses in patients with type 2 diabetes, a similar proportion of patients in each dose group reported diabetic retinopathy related adverse reactions during the trial; 1.3% and 1.9% of patients in the 9 mg and 25 mg semaglutide group, respectively, reported moderate-severe non-proliferative diabetic retinopathy events, and 0% and 0.4% reported proliferative retinopathy events, respectively. In a 2-year trial with semaglutide 0.5 mg and 1 mg once-weekly injection in adult patients with type 2 diabetes and high cardiovascular risk, diabetic retinopathy complications (which was a 4-component adjudicated endpoint) occurred in patients treated with semaglutide injection (3%) compared to placebo (1.8%). The absolute risk increase for diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (semaglutide injection 8.2%, placebo 5.2%) than among patients without a known history of diabetic retinopathy (semaglutide injection 0.7%, placebo 0.4%). Gastrointestinal Adverse Reactions In clinical trials in adults for weight reduction, 73% of WEGOVY injection-treated patients and 47% of patients receiving placebo reported gastrointestinal adverse reactions, including severe reactions that were reported more frequently among patients receiving WEGOVY injection (4.1%) than placebo (0.9%). The most frequently reported reactions were nausea (44% vs. 16%), vomiting (25% vs. 6%), and diarrhea (30% vs. 16%). Other reactions that occurred at a higher incidence among WEGOVY injection-treated adult patients included dyspepsia, abdominal pain, abdominal distension, eructation, flatulence, gastroesophageal reflux disease, gastritis, hemorrhoids, and hiccups. These reactions were most frequently reported during dosage escalation. Severe gastrointestinal adverse reactions were reported in 2% of WEGOVY tablet-treated and 0% of placebo-treated patients, respectively. In the pediatric clinical trial for weight reduction, 62% of WEGOVY injection-treated patients and 42% of placebo-treated patients reported gastrointestinal adverse reactions. The most frequently reported reactions were nausea (42% vs. 18%), vomiting (36% vs. 10%), and diarrhea (22% vs. 19%). Other gastrointestinal-related reactions that occurred at a higher incidence than placebo among WEGOVY injection-treated pediatric patients included abdominal pain, constipation, eructation, gastroesophageal reflux disease, dyspepsia, and flatulence. Permanent discontinuation of treatment as a result of a gastrointestinal adverse reaction occurred in 4.3% of WEGOVY injection-treated adult patients versus 0.7% of placebo-treated patients. In a pediatric clinical trial for weight reduction, 2.3% of patients treated with WEGOVY injection versus 1.5% of patients who received placebo discontinued treatment as a result of gastrointestinal adverse reactions. Dysesthesia Dysesthesia, and related events of altered skin sensations including paresthesia, pain of skin, sensitive skin, and burning skin sensation, occurred in clinical trials with WEGOVY injection and tablet. The incidence of dysesthesia with WEGOVY increased with increasing dosage and drug levels in the blood. In clinical trials evaluating patients with and without type 2 diabetes mellitus, WEGOVY 7.2 mg injection dysesthesia was reported at a higher rate in the WEGOVY 7.2 mg injection group (22%), compared to WEGOVY 2.4 mg injection (6%) and placebo (0.3%). Among 288 patients who experienced dysesthesia with WEGOVY 7.2 mg injection, 2% permanently discontinued treatment, 8% had temporary interruption, and 23% had dose reduction; most subjects with these actions taken to WEGOVY 7.2 mg injection (permanent discontinuation, temporary interruption, or dose reduction) recovered from the event. When an action was taken with WEGOVY, events resolved faster than the events where no action was taken with WEGOVY. Among patients who experienced dysesthesia with WEGOVY 7.2 mg injection, 18% did not report recovering during the trial duration; in most of the patients who did not recover, the WEGOVY dosage was unchanged and not discontinued. Of the patients who recovered after action taken with WEGOVY, 38 patients were re-escalated to 7.2 mg. Of these 38 patients, 17 (45%) subsequently reported recurrence of dysesthesia. In a clinical trial with WEGOVY 25 mg tablets, 5% of WEGOVY-treated patients and no placebo-treated patients reported dysesthesia adverse reactions. Other Adverse Reactions in Adults and/or Pediatric Patients The below adverse reactions were reported in WEGOVY injection clinical trials and are applicable to both WEGOVY injection and WEGOVY tablets. The safety of WEGOVY tablets have not been established in pediatric patients or patients with MASH. Acute Pancreatitis In WEGOVY clinical trials in adults for weight reduction, acute pancreatitis was confirmed by adjudication in 4 WEGOVY-treated patients (0.2 cases per 100 patient years) and 1 in placebo-treated patients (less than 0.1 cases per 100 patient years). One additional case of acute pancreatitis was confirmed in a patient treated with WEGOVY in another clinical trial. Acute Kidney Injury Acute kidney injury occurred in clinical trials for weight reduction in 7 adult patients (0.4 cases per 100 patient years) receiving WEGOVY versus 4 patients (0.2 cases per 100 patient years of exposure) receiving placebo. Some of these adverse reactions occurred in association with gastrointestinal adverse reactions or dehydration. In addition, 2 patients treated with WEGOVY had acute kidney injury with dehydration in other clinical trials. The risk of renal adverse reactions with WEGOVY was increased in adult patients with a history of renal impairment (trials included 65 patients with a history of moderate or severe renal impairment at baseline), and occurred more frequently during dose titration. Increase in Heart Rate Mean increases in resting heart rate of 1 to 4 beats per minute (bpm) were observed with routine clinical monitoring in WEGOVY-treated adult patients compared to placebo in clinical trials for weight reduction. In weight reduction trials in which adult patients were randomized prior to dose-escalation, more patients treated with WEGOVY, compared with placebo, had maximum changes from baseline at any visit of 10 to 19 bpm (41% versus 34%, respectively) and 20 bpm or more (26% versus 16%, respectively). In a clinical trial for weight reduction in pediatric patients aged 12 years and older with normal baseline heart rate, more patients treated with WEGOVY compared to placebo had maximum changes in heart rate of 20 bpm or more (54% versus 39%). Hypotension and Syncope Adverse reactions related to hypotension (hypotension, orthostatic hypotension, and decreased blood pressure) were reported in 1.3% of WEGOVY-treated adult patients versus 0.4% of placebo-treated patients and syncope was reported in 0.8% of WEGOVY-treated patients versus 0.2% of placebo-treated patients in clinical trials for weight reduction. Some reactions were related to gastrointestinal adverse reactions and volume loss associated with WEGOVY. Hypotension and orthostatic hypotension were more frequently seen in patients on concomitant antihypertensive therapy. In a clinical trial in pediatric patients aged 12 years and older for weight reduction, hypotension was reported in 2.3% of WEGOVY-treated patients versus 0% in placebo-treated patients. Appendicitis Appendicitis (including perforated appendicitis) occurred in 10 (0.5%) WEGOVY-treated adult patients and 2 (0.2%) patients receiving placebo in clinical trials for weight reduction. Injection Site Reactions In clinical trials in adults for weight reduction, 1.4% of WEGOVY-treated patients and 1% of patients receiving placebo experienced injection site reactions (including injection site pruritus, erythema, inflammation, induration, and irritation). Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with WEGOVY. In a pediatric clinical trial for weight reduction, rash was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients, and urticaria was reported in 3% of WEGOVY-treated patients and 0% of placebo-treated patients . In adult clinical trials for weight reduction, allergic reactions occurred in 16% (8/50) of WEGOVY-treated patients with anti-semaglutide antibodies and in 7% (114/1659) of WEGOVY-treated patients who did not develop anti-semaglutide antibodies [see Clinical Pharmacology ( 12.6 )]. Fractures In the CV outcomes trial in adults, more fractures of the hip and pelvis were reported on WEGOVY than on placebo in female patients: 1% (24/2,448) vs. 0.2% (5/2,424), and in patients ages 75 years and older: 2.4% (17/703) vs. 0.6% (4/663), respectively. In a clinical trial in adults with MASH, fractures occurred in 4.4% of WEGOVY-treated patients (2.6 cases per 100 patient years) compared to 3.3% of placebo-treated patients (2 cases per 100 patient years). Fractures were reported in both males and females with a median age of 61 years (range, 44 to 75). Urolithiasis In a CV outcomes trial, 1.2% of WEGOVY-treated patients and 0.8% of patients receiving placebo reported urolithiasis, including serious reactions that were reported more frequently among patients receiving WEGOVY (0.6%) than placebo (0.4%). Dysgeusia In clinical trials in adults for weight reduction, 1.7% of WEGOVY-treated patients and 0.5% of placebo-treated patients reported dysgeusia. Hair Loss Hair loss adverse reactions in WEGOVY injection-treated patients were associated with weight reduction. In a pool of studies 2, 3, and 4, hair loss was reported in 3.3% of patients treated with WEGOVY 2.4 mg (4% female, 0.9% male) and in 1% of patients treated with placebo (2% female, 0 male). In a pediatric trial, hair loss was reported in 4% of patients treated with 2.4 mg of WEGOVY and no placebo-treated patients. In clinical trials with WEGOVY 7.2 mg injection, hair loss was reported in 5.8% of patients treated with WEGOVY 7.2 mg (8.4% female, 0.2% male), 3.3% of patients treated with WEGOVY 2.4 mg (5.4% female, 0 male), and 1.0% of patients on placebo (1.5% female, 0 male). In the WEGOVY 7.2 mg group, 1 event led to permanent treatment discontinuation, 1 event led to temporary interruption, and 5 events led to dose reduction, versus none of these actions in the WEGOVY 2.4 mg or placebo groups. Laboratory Abnormalities in Adults and/or Pediatric Patients Treated with WEGOVY Injection The below laboratory abnormalities are applicable for both WEGOVY injection and WEGOVY tablets and include descriptions of WEGOVY injection clinical trial data, where relevant. The safety and effectiveness of WEGOVY tablets have not been established in pediatric patients or patients with MASH. Amylase and Lipase Adult and pediatric patients treated with WEGOVY had a mean increase from baseline in amylase of 15% to 16% and lipase of 39% in clinical trials for weight reduction. These changes were not observed in the placebo group. In a clinical trial in adults with MASH, increases in lipase greater than 3 times the upper limit of normal (ULN) occurred in 4.7% (35/750) of WEGOVY-treated patients compared with 1.3% (5/374) of placebo-treated patients. The clinical significance of elevations in lipase or amylase with WEGOVY is unknown in the absence of other signs and symptoms of pancreatitis. Liver Tests In a pediatric clinical trial for weight reduction, increases in alanine aminotransferase (ALT) greater than or equal to 5 times the ULN were observed in 4 (3%) WEGOVY-treated patients compared with 0% of placebo-treated patients. In some patients, increases in ALT and AST were associated with other confounding factors (such as gallstones). In the CV outcomes trial in adults, increases in total bilirubin greater than or equal to 3 times the ULN were observed in 0.3% (30/8,585) of WEGOVY-treated patients versus 0.2% (14/8,579) of placebo-treated patients. 6.2 Postmarketing Experience The following adverse reactions have been reported during post-approval use of semaglutide, the active ingredient of WEGOVY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders: acute pancreatitis and necrotizing pancreatitis, sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction Hypersensitivity: anaphylaxis, angioedema, rash, urticaria Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation Renal and Urinary Disorders: acute kidney injury