Effexor XR Side Effects
Generic Name: Venlafaxine
Please note - some side effects for Effexor XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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For the consumer For the professional
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Side Effects of Effexor XR - for the consumer
Effexor XR Extended-Release Capsules
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Effexor XR Extended-Release Capsules:
Seek medical attention right away if any of these SEVERE side effects occur when using Effexor XR Extended-Release Capsules:Abnormal dreams; blurred vision; changes in taste; constipation; decreased sexual desire or ability; dizziness; drowsiness; dry mouth; flushing; headache; increased sweating; loss of appetite; nausea; nervousness; stomach upset; trouble sleeping; vomiting; weakness; weight loss; yawning.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; chest pain or discomfort; confusion; decreased urination; fast or irregular heartbeat; fever, chills, or sore throat; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; persistent or severe ringing in the ears; seizures; severe or persistent anxiety, nervousness, or trouble sleeping; severe or persistent cough; severe or persistent headache, dizziness, or stomach pain; shortness of breath; significant weight loss; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; vision problems; worsening of depression.
For the professional
Effexor XR
The information included in the Adverse Findings Observed in Short-Term, Placebo‑Controlled Studies with Effexor XR subsection is based on data from a pool of three 8- and 12‑week controlled clinical trials in major depressive disorder (includes two U.S. trials and one European trial), on data up to 8 weeks from a pool of five controlled clinical trials in GAD with Effexor XR®, on data up to 12 weeks from a pool of two controlled clinical trials in Social Anxiety Disorder, and on data up to 12 weeks from a pool of four controlled clinical trials in panic disorder. Information on additional adverse events associated with Effexor XR in the entire development program for the formulation and with Effexor (the immediate release formulation of venlafaxine) is included in the Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR subsection.
Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR
Adverse Events Associated with Discontinuation of TreatmentApproximately 11% of the 357 patients who received Effexor XR® (venlafaxine hydrochloride) extended-release capsules in placebo-controlled clinical trials for major depressive disorder discontinued treatment due to an adverse experience, compared with 6% of the 285 placebo‑treated patients in those studies. Approximately 18% of the 1381 patients who received Effexor XR capsules in placebo-controlled clinical trials for GAD discontinued treatment due to an adverse experience, compared with 12% of the 555 placebo-treated patients in those studies. Approximately 17% of the 277 patients who received Effexor XR capsules in placebo-controlled clinical trials for Social Anxiety Disorder discontinued treatment due to an adverse experience, compared with 5% of the 274 placebo-treated patients in those studies. Approximately 7% of the 1,001 patients who received Effexor XR capsules in placebo-controlled clinical trials for panic disorder discontinued treatment due to an adverse experience, compared with 6% of the 662 placebo-treated patients in those studies. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the Effexor XR-treated patients at a rate at least twice that of placebo for any indication) are shown in Table 3.
| Percentage of Patients Discontinuing Due to Adverse Event | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Adverse Event | Major Depressive Disorder Indication2 | GAD Indication3,4 | Social Anxiety Disorder Indication | Panic Disorder Indication | |||||
| Effexor XR n = 357 |
Placebo n = 285 |
Effexor XR n = 1381 |
Placebo n = 555 |
Effexor XR n = 277 |
Placebo n = 274 |
Effexor XR n = 1001 |
Placebo n = 662 |
||
1 Two of the major depressive disorder
studies were flexible dose and one was fixed dose. Four of the GAD
studies were fixed dose and one was flexible dose. Both of the Social
Anxiety Disorder studies were flexible dose. Two of the panic disorder
studies were flexible dose and two were fixed dose. | |||||||||
| Body as a Whole | |||||||||
| Asthenia Headache |
-- -- |
-- -- |
3% -- |
<1% -- |
1% 2% |
<1% <1% |
1% -- |
0% -- |
|
| Digestive System | |||||||||
| Nausea Anorexia Dry Mouth Vomiting |
4% 1% 1% -- |
<1% <1% 0% -- |
8% -- 2% 1% |
<1% -- <1% <1% |
4% -- -- -- |
0% -- -- -- |
2% -- -- -- |
<1% -- -- -- |
|
| Nervous System | |||||||||
| Dizziness Insomnia Somnolence Nervousness Tremor Anxiety |
2% 1% 2% -- -- -- |
1% <1% <1% -- -- -- |
-- 3% 3% 2% 1% -- |
-- <1% <1% <1% 0% -- |
2% 3% 2% -- -- 1% |
0% <1% <1% -- -- <1% |
-- 1% -- -- -- -- |
-- <1% -- -- -- -- |
|
| Skin | |||||||||
| Sweating | -- | -- | 2% | <1% | 1% | 0% | -- | -- | |
| Urogenital System | |||||||||
| Impotence | -- | -- | -- | -- | 3%5 | 0% | -- | -- | |
Tables 4, 5, 6, and 7 enumerate the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of major depressive disorder (up to 12 weeks; dose range of 75 to 225 mg/day), of GAD (up to 8 weeks; dose range of 37.5 to 225 mg/day), of Social Anxiety Disorder (up to 12 weeks; dose range of 75 to 225 mg/day), and of panic disorder (up to 12 weeks; dose range of 37.5 to 225 mg/day), respectively, in 2% or more of patients treated with Effexor XR (venlafaxine hydrochloride) where the incidence in patients treated with Effexor XR was greater than the incidence for the respective placebo-treated patients. The table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
Commonly Observed Adverse Events from Tables 4, 5, 6, and 7:
Major Depressive Disorder
Note in particular the following adverse events that occurred in at least 5% of the Effexor XR patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the major depressive disorder indication (Table 4): Abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating. In the two U.S. placebo-controlled trials, the following additional events occurred in at least 5% of Effexor XR-treated patients (n = 192) and at a rate at least twice that of the placebo group: Abnormalities of sexual function (impotence in men, anorgasmia in women, and libido decreased), gastrointestinal complaints (constipation and flatulence), CNS complaints (insomnia, nervousness, and tremor), problems of special senses (abnormal vision), cardiovascular effects (hypertension and vasodilatation), and yawning.
Generalized Anxiety Disorder
Note in particular the following adverse events that occurred in at least 5% of the Effexor XR patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the GAD indication (Table 5): Abnormalities of sexual function (abnormal ejaculation and impotence), gastrointestinal complaints (nausea, dry mouth, anorexia, and constipation), problems of special senses (abnormal vision), and sweating.
Social Anxiety Disorder
Note in particular the following adverse events that occurred in at least 5% of the Effexor XR patients and at a rate at least twice that of the placebo group for the 2 placebo-controlled trials for the Social Anxiety Disorder indication (Table 6): Asthenia, gastrointestinal complaints (anorexia, dry mouth, nausea), CNS complaints (anxiety, insomnia, libido decreased, nervousness, somnolence, dizziness), abnormalities of sexual function (abnormal ejaculation, orgasmic dysfunction, impotence), yawn, sweating, and abnormal vision.
Panic Disorder
Note in particular the following adverse events that occurred in at least 5% of the Effexor XR patients and at a rate at least twice that of the placebo group for 4 placebo-controlled trials for the panic disorder indication (Table 7): gastrointestinal complaints (anorexia, constipation, dry mouth), CNS complaints (somnolence, tremor), abnormalities of sexual function (abnormal ejaculation), and sweating.
| % Reporting Event | ||
|
Body System Preferred Term |
Effexor XR (n = 357) |
Placebo (n = 285) |
1 Incidence, rounded to the nearest %, for events reported
by at least 2% of patients treated with Effexor XR, except the
following events which had an incidence equal to or less than placebo:
abdominal pain, accidental injury, anxiety, back pain, bronchitis,
diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection,
pain, palpitation, rhinitis, and sinusitis. | ||
| Body as a Whole | ||
| Asthenia | 8% | 7% |
| Cardiovascular System | ||
| Vasodilatation3 Hypertension |
4% 4% |
2% 1% |
| Digestive System | ||
| Nausea Constipation Anorexia Vomiting Flatulence |
31% 8% 8% 4% 4% |
12% 5% 4% 2% 3% |
| Metabolic/Nutritional | ||
| Weight Loss | 3% | 0% |
| Nervous System | ||
| Dizziness Somnolence Insomnia Dry Mouth Nervousness Abnormal Dreams4 Tremor Depression Paresthesia Libido Decreased Agitation |
20% 17% 17% 12% 10% 7% 5% 3% 3% 3% 3% |
9% 8% 11% 6% 5% 2% 2% <1% 1% <1% 1% |
| Respiratory System | ||
| Pharyngitis Yawn |
7% 3% |
6% 0% |
| Skin | ||
| Sweating | 14% | 3% |
| Special Senses | ||
| Abnormal Vision5 | 4% | <1% |
| Urogenital System | ||
| Abnormal Ejaculation (male)6,7 Impotence7 Anorgasmia (female)8,9 |
16% 4% 3% |
<1% <1% <1% |
| % Reporting Event | ||
|
Body System Preferred Term |
Effexor XR (n = 1381) |
Placebo (n = 555) |
1 Adverse events for which the Effexor XR reporting
rate was less than or equal to the placebo rate are not included.
These events are: abdominal pain, accidental injury, anxiety, back
pain, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection,
myalgia, pain, palpitation, pharyngitis, rhinitis, tinnitus, and urinary
frequency. | ||
| Body as a Whole | ||
| Asthenia | 12% | 8% |
| Cardiovascular System | ||
| Vasodilatation3 | 4% | 2% |
| Digestive System | ||
| Nausea Constipation Anorexia Vomiting |
35% 10% 8% 5% |
12% 4% 2% 3% |
| Nervous System | ||
| Dizziness Dry Mouth Insomnia Somnolence Nervousness Libido Decreased Tremor Abnormal Dreams4 Hypertonia Paresthesia |
16% 16% 15% 14% 6% 4% 4% 3% 3% 2% |
11% 6% 10% 8% 4% 2% <1% 2% 2% 1% |
| Respiratory System | ||
| Yawn | 3% | <1% |
| Skin | ||
| Sweating | 10% | 3% |
| Special Senses | ||
| Abnormal Vision5 | 5% | <1% |
| Urogenital System | ||
| Abnormal Ejaculation6,7 Impotence7 Orgasmic Dysfunction (female)8,9 |
11% 5% 2% |
<1% <1% 0% |
| % Reporting Event | ||
|
Body System Preferred Term |
Effexor XR (n = 277) |
Placebo (n = 274) |
1 Adverse events for which the Effexor XR reporting
rate was less than or equal to the placebo rate are not included.
These events are: back pain, depression, dysmenorrhea, dyspepsia,
infection, myalgia, pain, pharyngitis, rash, rhinitis, and upper respiratory
infection. | ||
| Body as a Whole | ||
| Headache Asthenia Flu Syndrome Accidental Injury Abdominal Pain |
34% 17% 6% 5% 4% |
33% 8% 5% 3% 3% |
| Cardiovascular System | ||
| Hypertension Vasodilatation3 Palpitation |
5% 3% 3% |
4% 1% 1% |
| Digestive System | ||
| Nausea Anorexia4 Constipation Diarrhea Vomiting Eructation |
29% 20% 8% 6% 3% 2% |
9% 1% 4% 5% 2% 0% |
| Metabolic/Nutritional | ||
| Weight Loss | 4% | 0% |
| Nervous System | ||
| Insomnia Dry Mouth Dizziness Somnolence Nervousness Libido Decreased Anxiety Agitation Tremor Abnormal Dreams5 Paresthesia Twitching |
23% 17% 16% 16% 11% 9% 5% 4% 4% 4% 3% 2% |
7% 4% 8% 8% 3% <1% 3% 1% <1% <1% <1% 0% |
| Respiratory System | ||
| Yawn Sinusitis |
5% 2% |
<1% 1% |
| Skin | ||
| Sweating | 13% | 2% |
| Special Senses | ||
| Abnormal Vision6 | 6% | 3% |
| Urogenital System | ||
| Abnormal Ejaculation7,8 Impotence8 Orgasmic Dysfunction9,10 |
16% 10% 8% |
1% 1% 0% |
| % Reporting Event | ||
|
Body System Preferred Term |
Effexor XR (n = 1001) |
Placebo (n = 662) |
1 Adverse events for which the Effexor XR reporting
rate was less than or equal to the placebo rate are not included.
These events are: abdominal pain, abnormal vision, accidental injury,
anxiety, back pain, diarrhea, dysmenorrhea, dyspepsia, flu syndrome,
headache, infection, nervousness, pain, paresthesia, pharyngitis,
rash, rhinitis, and vomiting. | ||
| Body as a Whole | ||
| Asthenia | 10% | 8% |
| Cardiovascular System | ||
| Hypertension Vasodilatation3 |
4% 3% |
3% 2% |
| Digestive System | ||
| Nausea Dry mouth Constipation Anorexia4 |
21% 12% 9% 8% |
14% 6% 3% 3% |
| Nervous System | ||
| Insomnia Somnolence Dizziness Tremor Libido Decreased |
17% 12% 11% 5% 4% |
9% 6% 10% 2% 2% |
| Skin | ||
| Sweating | 10% | 2% |
| Urogenital System | ||
| Abnormal Ejaculation5,6 Impotence6 Orgasmic Dysfunction7,8 |
8% 4% 2% |
<1% <1% <1% |
Vital Sign Changes
Effexor XR (venlafaxine hydrochloride) extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled major depressive disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 2 beats per minute, compared with 1 beat per minute for placebo. Effexor XR treatment for up to 8 weeks in premarketing placebo-controlled GAD trials was associated with a mean final on-therapy increase in pulse rate of approximately 2 beats per minute, compared with less than 1 beat per minute for placebo. Effexor XR treatment for up to 12 weeks in premarketing placebo‑controlled Social Anxiety Disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 4 beats per minute, compared with an increase of 1 beat per minute for placebo. Effexor XR treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 1 beat per minute, compared with a decrease of less than 1 beat per minute for placebo.
In a flexible-dose study, with Effexor doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean pulse was increased by about 2 beats per minute compared with a decrease of about 1 beat per minute for placebo.
Laboratory Changes
Effexor XR (venlafaxine hydrochloride) extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled trials for major depressive disorder was associated with a mean final on-therapy increase in serum cholesterol concentration of approximately 1.5 mg/dL compared with a mean final decrease of 7.4 mg/dL for placebo. Effexor XR treatment for up to 8 weeks and up to 6 months in premarketing placebo-controlled GAD trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 1.0 mg/dL and 2.3 mg/dL, respectively while placebo subjects experienced mean final decreases of 4.9 mg/dL and 7.7 mg/dL, respectively. Effexor XR treatment for up to 12 weeks in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 11.4 mg/dL compared with a mean final decrease of 2.2 mg/dL for placebo. Effexor XR treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.8 mg/dL compared with a mean final decrease of 3.7 mg/dL for placebo.
Patients treated with Effexor tablets (the immediate-release form of venlafaxine) for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on‑therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, or 2) an average on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients.
ECG Changes
In a flexible-dose study, with Effexor doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean change in heart rate was 8.5 beats per minute compared with 1.7 beats per minute for placebo.
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More resources:
Effexor XR Extended-Release Capsules
Effexor XR - Includes detailed dosage instructions.
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