XPOVIO

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Brand name
XPOVIO
Generic name
SELINEXOR
Manufacturer
Karyopharm Therapeutics Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
f6dd2682-75a6-4863-90a8-a3197f6f78a8
SPL ID
5e9b366c-3fc4-4178-bb80-687e21f9beff
Version
18
Effective date
2026-05-12
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:19:14
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS Thrombocytopenia : Monitor platelet counts throughout treatment. Manage with dose interruption and/or reduction and supportive care ( 2.4 , 5.1 ). Neutropenia : Monitor neutrophil counts throughout treatment. Manage with dose interruption and/or reduction and granulocyte colony-stimulating factors ( 2.4 , 5.2 ). Gastrointestinal Toxicity : Nausea, vomiting, diarrhea, anorexia, and weight loss may occur. Provide antiemetic prophylaxis. Manage with dose interruption and/or reduction, antiemetics, and supportive care ( 2.4 , 5.3 ). Hyponatremia : Monitor serum sodium levels throughout treatment. Correct for concurrent hyperglycemia and high serum paraprotein levels. Manage with dose interruption, reduction, or discontinuation, and supportive care ( 2.4 , 5.4 ). Serious Infection : Monitor for infection and treat promptly ( 5.2 , 5.5 ). Neurological Toxicity : Advise patients to refrain from driving and engaging in hazardous occupations or activities until neurological toxicity resolves. Optimize hydration status and concomitant medications to avoid dizziness or mental status changes ( 5.6 ). Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential and males with a female partner of reproductive potential, of the potential risk to a fetus and use of effective contraception ( 5.7 , 8.1 , 8.3 ). Cataract : Cataracts may develop or progress. Treatment of cataracts usually requires surgical removal of the cataract ( 5.8 ). 5.1 Thrombocytopenia XPOVIO can cause life-threatening thrombocytopenia, potentially leading to hemorrhage. Thrombocytopenia is the leading cause of dosage modifications [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), thrombocytopenia was reported in 92% of patients and severe (Grade 3-4) thrombocytopenia was reported in 43% of patients. The median time to first onset was 22 days for any grade thrombocytopenia and 43 days for Grade 3 or 4 thrombocytopenia. Bleeding occurred in 16% of patients with thrombocytopenia, clinically significant bleeding (Grade ≥3 bleeding) occurred in 4% of patients with thrombocytopenia, and fatal hemorrhage occurred in 2% of patients with thrombocytopenia. Permanent discontinuations of XPOVIO due to thrombocytopenia occurred in 2% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), thrombocytopenia was reported as an adverse reaction in 74% of patients and severe (Grade 3-4) thrombocytopenia was reported in 61% of patients. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia, and fatal hemorrhage occurred in <1% of patients. Monitor platelet counts at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt, reduce dose, or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )]. 5.2 Neutropenia XPOVIO can cause life-threatening neutropenia, potentially increasing the risk of infection [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neutropenia was reported in 48% of patients and severe neutropenia (Grade 3-4) was reported in 12% of patients. The median time to onset of the first event was 23 days for any grade neutropenia and 40 days for Grade 3-4 neutropenia. Febrile neutropenia was reported in <1% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neutropenia was reported as an adverse reaction in 34% of patients and severe (Grade 3-4) neutropenia was reported in 21% of patients. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients. Obtain white blood cell counts with differential at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures, including antimicrobials and growth factors (e.g., G-CSF). Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )]. 5.3 Gastrointestinal Toxicity XPOVIO can cause severe gastrointestinal toxicities [see Adverse Reactions ( 6.1 )] . Nausea/Vomiting In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195) with use of antiemetic prophylaxis (88% of patients), nausea was reported in 50% of patients and Grade 3 nausea was reported in 8% of patients. The median time to onset of the first event was 6 days. Vomiting was reported in 21% of patients and Grade 3 vomiting was reported in 4.1% of patients. The median time to onset of the first event was 8 days. Permanent discontinuation due to nausea occurred in 3.1% of patients and due to vomiting occurred in 2.1% of patients. In patients with multiple myeloma receiving XPOVIO 80 mg twice weekly (STORM, n=202) with use of antiemetic prophylaxis, nausea was reported as an adverse reaction in 72% of patients and Grade 3 nausea occurred in 9%. The median time to first onset of nausea was 3 days. Vomiting was reported in 41% of patients and Grade 3 vomiting occurred in 4% of patients. The median time to first onset of vomiting was 5 days. Provide prophylactic antiemetics. Administer 5-HT3 receptor antagonists and other anti-nausea agents prior to and during treatment with XPOVIO. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )] . Administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated. Diarrhea In patients with multiple myeloma who received XPOVIO once weekly (BOSTON, n=195), diarrhea was reported in 32% of patients and Grade 3 diarrhea was reported in 6% of patients. The median time to onset of the first event was 50 days. Permanent discontinuation due to diarrhea occurred in 1% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), diarrhea was reported as an adverse reaction in 44% of patients and Grade 3 diarrhea occurred in 6% of patients. The median time to onset of diarrhea was 15 days. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )] . Provide standard anti-diarrheal agents, administer intravenous fluids to prevent dehydration and replace electrolytes as clinically indicated. Anorexia/Weight Loss In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), anorexia was reported in 35% of patients and Grade 3 anorexia was reported in 3.6% of patients. The median time to onset of the first event was 35 days. Permanent discontinuations due to anorexia occurred in 2.1% of patients. Weight loss was reported in 26% of patients and Grade 3 weight loss was reported in 2.1% of patients. The median time to onset of the first event was 58 days. Permanent discontinuation due to weight loss occurred in 1% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM n=202), anorexia was reported as an adverse reaction in 53% of patients and Grade 3 anorexia occurred in 5% of patients. The median time to onset of anorexia was 8 days. Weight loss was reported as an adverse reaction in 47% of patients and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days. Monitor weight, nutritional status, and volume status at baseline and throughout treatment. Monitor more frequently during the first three months of treatment. Interrupt, reduce dose or permanently discontinue based on severity of adverse reaction [see Dosage and Administration ( 2.4 )]. Provide nutritional support, fluids, and electrolyte repletion as clinically indicated. 5.4 Hyponatremia XPOVIO can cause severe or life-threatening hyponatremia [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), hyponatremia was reported in 58% of patients and Grade 3-4 hyponatremia was reported in 14% of patients. The median time to first onset was 21 days for any grade hyponatremia and the median time to first onset for Grade 3 or 4 hyponatremia was 22 days. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), hyponatremia was reported as an adverse reaction in 39% of patients and Grade 3 or 4 hyponatremia was reported in 22% of patients. The median time to onset of the first event was 8 days. Monitor sodium level at baseline and throughout treatment. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Assess hydration status and manage hyponatremia per clinical guidelines, including intravenous saline and/or salt tablets as appropriate and dietary review. Interrupt, reduce dose or permanently discontinue based on severity of the adverse reaction [see Dosage and Administration ( 2.4 )]. 5.5 Serious Infection XPOVIO can cause serious and fatal infections. Most of these infections were not associated with Grade 3 or higher neutropenia [see Adverse Reactions ( 6.1 )]. In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), 69% of patients experienced any grade of infection. Grade ≥3 infections were reported in 32% of patients, and deaths from infections occurred in 3.1% of patients. The most frequently reported Grade ≥3 infection was pneumonia in 14% of patients, followed by sepsis in 4.1% and upper respiratory tract infection in 3.6% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), 52% of patients experienced any grade of infection. Grade ≥3 infections were reported in 25% of patients, and deaths from infections occurred in 4% of patients within 30 days of last treatment. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. The most frequently reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Atypical infections reported after XPOVIO include, but are not limited to, fungal pneumonia and herpes virus infection. Monitor for signs and symptoms of infection, evaluate and treat promptly. 5.6 Neurological Toxicity XPOVIO can cause life-threatening neurological toxicities [see Adverse Reactions ( 6.1 )] . In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), neurological adverse reactions (excluding peripheral neuropathy) including dizziness, syncope, depressed level of consciousness, vertigo, amnesia, and mental status changes (including delirium and confusional state) occurred in 26% of patients and severe events (Grade 3-4) occurred in 3.6% of patients. The median time to the first event was 29 days. Permanent discontinuation due to neurological adverse reactions occurred in 2.1% of patients. In patients with multiple myeloma who received XPOVIO 80 mg twice weekly (STORM, n=202), neurological adverse reactions, including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients and severe events (Grade 3-4) occurred in 9% of patients. The median time to the first event was 15 days. Coadministration of XPOVIO with other products that cause dizziness or mental status changes may increase the risk of neurological toxicity. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, until the neurological toxicity fully resolves. Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes. Institute fall precautions as appropriate. 5.7 Embryo-Fetal Toxicity Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] . 5.8 Cataract New onset or exacerbation of cataract has occurred during treatment with XPOVIO [see Adverse Reactions ( 6.1 )]. In patients with multiple myeloma who received XPOVIO 100 mg once weekly (BOSTON, n=195), the incidence of new onset or worsening cataracts requiring clinical intervention was reported in 22% of patients. The median time to new onset of cataract was 228 days and was 237 days for worsening of cataract in patients presenting with cataract at start of XPOVIO therapy. Treatment of cataracts usually requires surgical removal of the cataract.

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described in detail in other labeling sections: Thrombocytopenia [see Warnings and Precautions ( 5.1 )] . Neutropenia [see Warnings and Precautions ( 5.2 )] . Gastrointestinal Toxicity [see Warnings and Precautions ( 5.3 )] . Hyponatremia [see Warnings and Precautions ( 5.4 )] . Serious Infection [see Warnings and Precautions ( 5.5 )] . Neurological Toxicity [see Warnings and Precautions ( 5.6 )] . Cataract [see Warnings and Precautions ( 5.8 )] . The most common adverse reactions (≥20%) in patients with multiple myeloma who receive XVd are fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight decreased, cataract, and vomiting. Grade 3-4 laboratory abnormalities (≥10%) are thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia ( 6.1 ). The most common adverse reactions (≥20%) in patients with multiple myeloma who receive Xd are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, weight decreased, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Karyopharm Therapeutics Inc. at 1-888-209-9326 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 trials of another drug and may not reflect the rates observed in practice. Multiple Myeloma XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) The safety of XPOVIO in combination with bortezomib and dexamethasone was evaluated in BOSTON [see Clinical Studies ( 14.1 )]. Patients were randomized to receive XPOVIO 100 mg orally once weekly in combination with bortezomib and dexamethasone (XVd) (n=195) or bortezomib and dexamethasone (Vd) (n=204). Among patients who received XPOVIO, the median duration of XPOVIO treatment was 29 weeks (range: 1 to 120 weeks) and the median dose was 80 mg (range: 30 to 137 mg) per week. Serious adverse reactions occurred in 52% of patients who received XPOVIO in combination with bortezomib and dexamethasone. Serious adverse reactions in >3% of patients included pneumonia (14%), sepsis, diarrhea and vomiting (4% each). Fatal adverse reactions occurred in 6% of patients within 30 days of last treatment, including pneumonia (n=3) and sepsis (n=3). Grade ≥2 peripheral neuropathy, a pre-specified key secondary endpoint, was lower in the XVd arm (21%) compared to the Vd arm (34%); odds ratio 0.50 [95% CI: 0.32, 0.79]. The median treatment duration was 30 weeks (range: 1-120 weeks) in patients who received once weekly XVd as compared to 32 weeks (range: 1-122 weeks) in patients who received twice weekly Vd. Permanent discontinuation of XPOVIO due to an adverse reaction occurred in 19% of patients. Adverse reactions which resulted in permanent discontinuation of XPOVIO in >2% of patients included fatigue (3.6%), nausea (3.1%), thrombocytopenia, decreased appetite, peripheral neuropathy, and vomiting (2.1% each). Dosage interruptions of XPOVIO due to an adverse reaction occurred in 83% of patients. Adverse reactions which required dosage interruption in >5% of patients included thrombocytopenia (33%), fatigue (13%), asthenia (12%), pneumonia (11%), upper respiratory tract infection (10%), decreased appetite (9%), neutropenia (8%), pyrexia (8%), nausea (7%), bronchitis (7%), diarrhea (6%), weight decreased (6%), and anemia (5%). Dose reductions of XPOVIO due to an adverse reaction occurred in 64% of patients. Adverse reactions which required dose reductions in >5% of patients included thrombocytopenia (31%), decreased appetite (8%), nausea, fatigue, weight decreased (7% each), and asthenia (6%). The most common adverse reactions (≥20% with a difference between arms of >5% compared to Vd) were fatigue, nausea, decreased appetite, diarrhea, peripheral neuropathy, upper respiratory tract infection, weight decreased, cataract, and vomiting. Grade 3-4 laboratory abnormalities (≥10%) were thrombocytopenia, lymphopenia, hypophosphatemia, anemia, hyponatremia, and neutropenia. Table 6 summarizes the adverse reactions in BOSTON. Table 6: Adverse Reactions (≥10%) in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) with a Difference Between Arms of >5% Compared to Vd in BOSTON Key: X=XPOVIO, Vd=bortezomib-dexamethasone a. Fatigue includes fatigue and asthenia. b. Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, peripheral sensorimotor neuropathy, toxic neuropathy, and peripheral motor neuropathy. c. Upper respiratory tract infection includes upper respiratory infection, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, and viral upper respiratory tract infection. d. Vision blurred includes blurred vision, visual acuity reduced, and visual impairment. Adverse Reaction Weekly XVd (n=195) Twice Weekly Vd (n=204) All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) Gastrointestinal Nausea 50 8 10 0 Diarrhea 32 6 25 <1 Vomiting 21 4.1 4.4 0 General Conditions Fatigue a 59 21 28 5 Pyrexia 15 1.5 11 1 Metabolism and Nutrition Decreased appetite 35 3.6 5 0 Weight decreased 26 2.1 12 1 Nervous System Peripheral neuropathy b 32 4.6 47 9 Dizziness 12 <1 3.9 0 Infections Upper respiratory tract infection c 29 3.6 22 1.5 Eye Disorders Cataract 22 9 6 1.5 Vision blurred d 13 <1 6 0 Clinically relevant adverse reactions in <10% of patients who received XPOVIO in combination with bortezomib and dexamethasone included: Neurologic disorders: mental status changes (9%) and syncope (3.6%) Table 7 summarizes selected laboratory abnormalities in BOSTON. Table 7: Select Laboratory Abnormalities (≥15%) That Worsened from Baseline in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) in BOSTON Laboratory Abnormality Weekly XVd Twice Weekly Vd All Grades (%) Grade 3 or 4 (%) All Grades (%) Grade 3 or 4 (%) The denominator used to calculate the rate varied from 91 to 201 based on the number of patients with at least one post-treatment value. a. Includes one fatal anemia. Hematologic Platelet count decrease 92 43 51 19 Lymphocyte count decrease 77 38 70 27 Hemoglobin decrease 71 17 51 a 12 Neutrophil count decrease 48 12 19 7 Chemistry Glucose increase 62 3.8 47 4.1 Phosphate decrease 61 23 42 11 Sodium decrease 58 14 25 3 Calcium decrease 55 2.1 47 1 Blood urea nitrogen increase 41 5 40 5 Creatinine increase 28 3.6 24 1.5 Potassium decrease 27 6 22 3.5 Magnesium decrease 27 <1 23 1.5 Potassium increase 18 4.1 21 2.5 Hepatic ALT increase 33 3.1 30 <1 Albumin decrease 27 <1 35 <1 AST increase 24 1.5 19 <1 Bilirubin increase 16 1 13 2 ALP increase 12 0 16 <1 XPOVIO in Combination with Dexamethasone (Xd) The safety of XPOVIO in combination with dexamethasone was evaluated in STORM [see Clinical Studies ( 14.1 )]. Patients received XPOVIO 80 mg orally with dexamethasone 20 mg on Days 1 and 3 of every week (n=202). The median duration of XPOVIO treatment was 8 weeks (range: 1 to 60 weeks). The median dose was 115 mg (range: 36 to 200 mg) per week. Fatal adverse reactions occurred in 9% of XPOVIO treated patients. Serious adverse reactions occurred in 58% of patients. The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65% had the dose of XPOVIO interrupted. Thrombocytopenia was the leading cause of dose modification, resulting in dose reduction and/or interruption in >25% of patients. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia. Table 8 summarizes the adverse reactions in STORM. Table 8: Adverse Reactions (≥10%) in Patients Who Received XPOVIO in STORM Adverse Reaction XPOVIO 80 mg twice weekly + Dexamethasone (n=202) a. Thrombocytopenia includes thrombocytopenia and platelet count decreased. b. Fatigue includes fatigue and asthenia. c. Anemia includes anemia and hematocrit decreased. d. Neutropenia includes neutropenia and neutrophil count decreased. e. Dyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest. f. Upper respiratory tract infection includes upper respiratory tract infection, respiratory tract infection, pharyngitis, nasopharyngitis, bronchitis, bronchiolitis, respiratory syncytial virus infection, parainfluenza virus infection, rhinitis, rhinovirus infection, and adenovirus infection. g. Cough includes cough, productive cough, and upper-airway cough syndrome. h. Mental status changes includes mental status changes, confusional state, and delirium. i. Hypercreatininemia includes hypercreatininemia and hypercreatinemia. j. Pneumonia includes pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia aspiration, pneumonia influenzal, and pneumonia viral. k. Includes fatal event. All Grades (%) Grades ≥3 (%) Thrombocytopenia a 74 61 Fatigue b 73 22 Nausea 72 9 Anemia c 59 40 Decreased appetite 53 4.5 Weight decreased 47 0.5 Diarrhea 44 6 Vomiting 41 3.5 Hyponatremia 39 22 Neutropenia d 34 21 Leukopenia 28 11 Constipation 25 1.5 Dyspnea e 24 3.5 k Upper respiratory tract infection f 21 3 Cough g 16 0 Mental status changes h 16 7 Pyrexia 16 0.5 Hyperglycemia 15 7 Dizziness 15 0 Insomnia 15 2 Lymphopenia 15 10 Dehydration 14 3.5 Hypercreatininemia i 14 2 Pneumonia j 13 9 k Epistaxis 12 0.5 Hypokalemia 12 3.5 Dysgeusia 11 0 Vision blurred 10 0.5 Headache 10 0

adverse reactions table

<table ID="t6" width="100%"><caption>Table 6: Adverse Reactions (&#x2265;10%) in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) with a Difference Between Arms of &gt;5% Compared to Vd in BOSTON </caption><col width="37.280%" align="left"/><col width="15.680%" align="left"/><col width="15.680%" align="left"/><col width="15.680%" align="left"/><col width="15.680%" align="left"/><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">Key: X=XPOVIO, Vd=bortezomib-dexamethasone </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">a. Fatigue includes fatigue and asthenia. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">b. Peripheral neuropathy includes neuropathy peripheral, peripheral sensory neuropathy, polyneuropathy, peripheral sensorimotor neuropathy, toxic neuropathy, and peripheral motor neuropathy. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">c. Upper respiratory tract infection includes upper respiratory infection, nasopharyngitis, pharyngitis, respiratory syncytial virus infection, respiratory tract infection, rhinitis, and viral upper respiratory tract infection. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">d. Vision blurred includes blurred vision, visual acuity reduced, and visual impairment. </paragraph></td></tr></tfoot><tbody><tr><td rowspan="2" align="left" valign="bottom" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Weekly XVd</content> <content styleCode="bold">(n=195)</content></td><td colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Twice Weekly Vd</content> <content styleCode="bold">(n=204)</content></td></tr><tr><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3 or 4</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3 or 4</content> <content styleCode="bold">(%)</content></td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Gastrointestinal</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Nausea </td><td align="center" valign="top" styleCode="Rrule">50 </td><td align="center" valign="top" styleCode="Rrule">8 </td><td align="center" valign="top" styleCode="Rrule">10 </td><td align="center" valign="top" styleCode="Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Diarrhea </td><td align="center" valign="top" styleCode="Rrule">32 </td><td align="center" valign="top" styleCode="Rrule">6 </td><td align="center" valign="top" styleCode="Rrule">25 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">4.1 </td><td align="center" valign="top" styleCode="Botrule Rrule">4.4 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">General Conditions</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Fatigue<sup>a</sup></td><td align="center" valign="top" styleCode="Rrule">59 </td><td align="center" valign="top" styleCode="Rrule">21 </td><td align="center" valign="top" styleCode="Rrule">28 </td><td align="center" valign="top" styleCode="Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Pyrexia </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">1.5 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Metabolism and Nutrition</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Decreased appetite </td><td align="center" valign="top" styleCode="Rrule">35 </td><td align="center" valign="top" styleCode="Rrule">3.6 </td><td align="center" valign="top" styleCode="Rrule">5 </td><td align="center" valign="top" styleCode="Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Weight decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">26 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.1 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Nervous System</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Peripheral neuropathy<sup>b</sup></td><td align="center" valign="top" styleCode="Rrule">32 </td><td align="center" valign="top" styleCode="Rrule">4.6 </td><td align="center" valign="top" styleCode="Rrule">47 </td><td align="center" valign="top" styleCode="Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Dizziness </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">&lt;1 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.9 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Infections</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Upper respiratory tract infection<sup>c</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">29 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.6 </td><td align="center" valign="top" styleCode="Botrule Rrule">22 </td><td align="center" valign="top" styleCode="Botrule Rrule">1.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Eye Disorders</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Cataract </td><td align="center" valign="top" styleCode="Rrule">22 </td><td align="center" valign="top" styleCode="Rrule">9 </td><td align="center" valign="top" styleCode="Rrule">6 </td><td align="center" valign="top" styleCode="Rrule">1.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Vision blurred<sup>d</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">&lt;1 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>

adverse reactions table

<table ID="t7" width="100%"><caption>Table 7: Select Laboratory Abnormalities (&#x2265;15%) That Worsened from Baseline in Patients with Multiple Myeloma Who Received XPOVIO in Combination with Bortezomib and Dexamethasone (XVd) in BOSTON </caption><col width="31.426%" align="left"/><col width="17.143%" align="left"/><col width="17.143%" align="left"/><col width="17.143%" align="left"/><col width="17.143%" align="left"/><thead><tr><th rowspan="2" align="left" valign="bottom" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Laboratory Abnormality</content></th><th colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Weekly XVd</content></th><th colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">Twice Weekly Vd</content></th></tr><tr><th align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></th><th align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3 or 4</content> <content styleCode="bold">(%)</content></th><th align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></th><th align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grade 3 or 4</content> <content styleCode="bold">(%)</content></th></tr></thead><tfoot><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">The denominator used to calculate the rate varied from 91 to 201 based on the number of patients with at least one post-treatment value. </paragraph></td></tr><tr><td colspan="5" align="left" valign="top"><paragraph styleCode="footnote">a. Includes one fatal anemia. </paragraph></td></tr></tfoot><tbody><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Hematologic</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Platelet count decrease </td><td align="center" valign="top" styleCode="Rrule">92 </td><td align="center" valign="top" styleCode="Rrule">43 </td><td align="center" valign="top" styleCode="Rrule">51 </td><td align="center" valign="top" styleCode="Rrule">19 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Lymphocyte count decrease </td><td align="center" valign="top" styleCode="Rrule">77 </td><td align="center" valign="top" styleCode="Rrule">38 </td><td align="center" valign="top" styleCode="Rrule">70 </td><td align="center" valign="top" styleCode="Rrule">27 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Hemoglobin decrease </td><td align="center" valign="top" styleCode="Rrule">71 </td><td align="center" valign="top" styleCode="Rrule">17 </td><td align="center" valign="top" styleCode="Rrule">51<sup>a</sup></td><td align="center" valign="top" styleCode="Rrule">12 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Neutrophil count decrease </td><td align="center" valign="top" styleCode="Botrule Rrule">48 </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">19 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Chemistry</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Glucose increase </td><td align="center" valign="top" styleCode="Rrule">62 </td><td align="center" valign="top" styleCode="Rrule">3.8 </td><td align="center" valign="top" styleCode="Rrule">47 </td><td align="center" valign="top" styleCode="Rrule">4.1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Phosphate decrease </td><td align="center" valign="top" styleCode="Rrule">61 </td><td align="center" valign="top" styleCode="Rrule">23 </td><td align="center" valign="top" styleCode="Rrule">42 </td><td align="center" valign="top" styleCode="Rrule">11 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Sodium decrease </td><td align="center" valign="top" styleCode="Rrule">58 </td><td align="center" valign="top" styleCode="Rrule">14 </td><td align="center" valign="top" styleCode="Rrule">25 </td><td align="center" valign="top" styleCode="Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Calcium decrease </td><td align="center" valign="top" styleCode="Rrule">55 </td><td align="center" valign="top" styleCode="Rrule">2.1 </td><td align="center" valign="top" styleCode="Rrule">47 </td><td align="center" valign="top" styleCode="Rrule">1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Blood urea nitrogen increase </td><td align="center" valign="top" styleCode="Rrule">41 </td><td align="center" valign="top" styleCode="Rrule">5 </td><td align="center" valign="top" styleCode="Rrule">40 </td><td align="center" valign="top" styleCode="Rrule">5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Creatinine increase </td><td align="center" valign="top" styleCode="Rrule">28 </td><td align="center" valign="top" styleCode="Rrule">3.6 </td><td align="center" valign="top" styleCode="Rrule">24 </td><td align="center" valign="top" styleCode="Rrule">1.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Potassium decrease </td><td align="center" valign="top" styleCode="Rrule">27 </td><td align="center" valign="top" styleCode="Rrule">6 </td><td align="center" valign="top" styleCode="Rrule">22 </td><td align="center" valign="top" styleCode="Rrule">3.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Magnesium decrease </td><td align="center" valign="top" styleCode="Rrule">27 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td><td align="center" valign="top" styleCode="Rrule">23 </td><td align="center" valign="top" styleCode="Rrule">1.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> Potassium increase </td><td align="center" valign="top" styleCode="Botrule Rrule">18 </td><td align="center" valign="top" styleCode="Botrule Rrule">4.1 </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">2.5 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"><content styleCode="bold">Hepatic</content></td><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/><td align="center" valign="top" styleCode="Rrule"/></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> ALT increase </td><td align="center" valign="top" styleCode="Rrule">33 </td><td align="center" valign="top" styleCode="Rrule">3.1 </td><td align="center" valign="top" styleCode="Rrule">30 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Albumin decrease </td><td align="center" valign="top" styleCode="Rrule">27 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td><td align="center" valign="top" styleCode="Rrule">35 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> AST increase </td><td align="center" valign="top" styleCode="Rrule">24 </td><td align="center" valign="top" styleCode="Rrule">1.5 </td><td align="center" valign="top" styleCode="Rrule">19 </td><td align="center" valign="top" styleCode="Rrule">&lt;1 </td></tr><tr><td align="left" valign="top" styleCode="Lrule Rrule"> Bilirubin increase </td><td align="center" valign="top" styleCode="Rrule">16 </td><td align="center" valign="top" styleCode="Rrule">1 </td><td align="center" valign="top" styleCode="Rrule">13 </td><td align="center" valign="top" styleCode="Rrule">2 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule"> ALP increase </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">&lt;1 </td></tr></tbody></table>

adverse reactions table

<table ID="t8" width="100%"><caption>Table 8: Adverse Reactions (&#x2265;10%) in Patients Who Received XPOVIO in STORM </caption><col width="49.467%" align="left"/><col width="25.267%" align="left"/><col width="25.267%" align="left"/><thead><tr><th rowspan="2" align="left" valign="bottom" styleCode="Toprule Botrule Lrule Rrule"><content styleCode="bold">Adverse Reaction</content></th><th colspan="2" align="center" valign="top" styleCode="Toprule Botrule Rrule"><content styleCode="bold">XPOVIO 80 mg twice weekly + Dexamethasone</content> <content styleCode="bold">(n=202)</content></th></tr></thead><tfoot><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">a. Thrombocytopenia includes thrombocytopenia and platelet count decreased. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">b. Fatigue includes fatigue and asthenia. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">c. Anemia includes anemia and hematocrit decreased. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">d. Neutropenia includes neutropenia and neutrophil count decreased. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">e. Dyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">f. Upper respiratory tract infection includes upper respiratory tract infection, respiratory tract infection, pharyngitis, nasopharyngitis, bronchitis, bronchiolitis, respiratory syncytial virus infection, parainfluenza virus infection, rhinitis, rhinovirus infection, and adenovirus infection. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">g. Cough includes cough, productive cough, and upper-airway cough syndrome. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">h. Mental status changes includes mental status changes, confusional state, and delirium. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">i. Hypercreatininemia includes hypercreatininemia and hypercreatinemia. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">j. Pneumonia includes pneumonia, atypical pneumonia, lung infection, lower respiratory tract infection, pneumocystis jirovecii pneumonia, pneumonia aspiration, pneumonia influenzal, and pneumonia viral. </paragraph></td></tr><tr><td colspan="3" align="left" valign="top"><paragraph styleCode="footnote">k. Includes fatal event. </paragraph></td></tr></tfoot><tbody><tr><td align="center" valign="top" styleCode="Botrule Lrule Rrule"> </td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">All Grades</content> <content styleCode="bold">(%)</content></td><td align="center" valign="top" styleCode="Botrule Rrule"><content styleCode="bold">Grades &#x2265;3 (%)</content></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Thrombocytopenia<sup>a</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">74 </td><td align="center" valign="top" styleCode="Botrule Rrule">61 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Fatigue<sup>b</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">73 </td><td align="center" valign="top" styleCode="Botrule Rrule">22 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Nausea </td><td align="center" valign="top" styleCode="Botrule Rrule">72 </td><td align="center" valign="top" styleCode="Botrule Rrule">9 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Anemia<sup>c</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">59 </td><td align="center" valign="top" styleCode="Botrule Rrule">40 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Decreased appetite </td><td align="center" valign="top" styleCode="Botrule Rrule">53 </td><td align="center" valign="top" styleCode="Botrule Rrule">4.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Weight decreased </td><td align="center" valign="top" styleCode="Botrule Rrule">47 </td><td align="center" valign="top" styleCode="Botrule Rrule">0.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Diarrhea </td><td align="center" valign="top" styleCode="Botrule Rrule">44 </td><td align="center" valign="top" styleCode="Botrule Rrule">6 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vomiting </td><td align="center" valign="top" styleCode="Botrule Rrule">41 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Hyponatremia </td><td align="center" valign="top" styleCode="Botrule Rrule">39 </td><td align="center" valign="top" styleCode="Botrule Rrule">22 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Neutropenia<sup>d</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">34 </td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Leukopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">28 </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Constipation </td><td align="center" valign="top" styleCode="Botrule Rrule">25 </td><td align="center" valign="top" styleCode="Botrule Rrule">1.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dyspnea<sup>e</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">24 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.5<sup>k</sup></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Upper respiratory tract infection<sup>f</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">21 </td><td align="center" valign="top" styleCode="Botrule Rrule">3 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Cough<sup>g</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Mental status changes<sup>h</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pyrexia </td><td align="center" valign="top" styleCode="Botrule Rrule">16 </td><td align="center" valign="top" styleCode="Botrule Rrule">0.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Hyperglycemia </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">7 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dizziness </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Insomnia </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Lymphopenia </td><td align="center" valign="top" styleCode="Botrule Rrule">15 </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dehydration </td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Hypercreatininemia<sup>i</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">14 </td><td align="center" valign="top" styleCode="Botrule Rrule">2 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pneumonia<sup>j</sup></td><td align="center" valign="top" styleCode="Botrule Rrule">13 </td><td align="center" valign="top" styleCode="Botrule Rrule">9<sup>k</sup></td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Epistaxis </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">0.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Hypokalemia </td><td align="center" valign="top" styleCode="Botrule Rrule">12 </td><td align="center" valign="top" styleCode="Botrule Rrule">3.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dysgeusia </td><td align="center" valign="top" styleCode="Botrule Rrule">11 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Vision blurred </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td><td align="center" valign="top" styleCode="Botrule Rrule">0.5 </td></tr><tr><td align="left" valign="top" styleCode="Botrule Lrule Rrule">Headache </td><td align="center" valign="top" styleCode="Botrule Rrule">10 </td><td align="center" valign="top" styleCode="Botrule Rrule">0 </td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.