effexor and sunburn
However, there is a dose dependency for blood pressure increase.
Laboratory Changes
Of the serum chemistry and hematology parameters monitored during clinical trials with Effexor, a statistically significant difference with placebo was seen only for serum cholesterol. The onset of venlafaxine- associated interstitial pneumonitis has ranged from 1 to 18 months after initial exposure to the drug and symptomatic improvement occurred after discontinuation of venlafaxine and treatment with corticosteroids.
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Effexor Detailed Consumer Information effexor and sunburn Prescribing Information (FDA)
Effexor Consumer Overview
Effexor Advanced Consumer (Micromedex) - Includes Dosage Information
Effexor MedFacts Consumer Leaflet (Wolters Kluwer)
Venlafaxine Prescribing Information (FDA)
Effexor XR Prescribing Information (FDA)
Effexor XR Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer). Withdrawal symptoms were reported to include brief bursts of dizziness associated with headache, anxiety, irritability, agitation, insomnia, paresthesias, nausea, vomiting, diarrhea, tremor, fatigue, sweating, and worsening of depression (similar to symptoms reported after withdrawal from selective serotonin reuptake inhibitors). In addition, in premarketing assessment of Effexor XR (the extended release form of venlafaxine), multiple doses were administered to 705 patients in Phase 3 major depressive disorder studies and Effexor was administered to 96 patients. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Impaired coordination and balance have been reported in postmarketing studies.
Seizures have been reported in 0.26% of treated patients during premarketing testing. The rule for including events was to enumerate those that occurred at an incidence of 5% or more for at least one of the venlafaxine groups and for which the incidence was at least twice the placebo incidence for at least one Effexor group. There have been postmarketing reports of toxic epidermal necrolysis.
One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Although rare, interstitial pneumonitis secondary to venlafaxine therapy has been reported. Although these events occurred during treatment with venlafaxine, causality has not been determined.
Hematologic
Hematologic side effects have included have frequently included abnormal bleeding (most commonly ecchymosis).
Hematologic side effects reported in premarketing Phase 3 trials have included anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia, basophilia, increased bleeding time, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura, and thrombocytopenia. 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 effexor and sunburn 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 an analysis of ECGs obtained in 769 patients treated with Effexor and 450 patients treated with placebo in controlled clinical trials, the only statistically significant difference observed was for heart rate, ie, a mean increase from baseline of 4 beats per minute for Effexor. The onset of withdrawal symptoms ranges from 14 to 48 hours after the last dose of venlafaxine extended-release and symptoms tend to resolve rapidly (range, within 2 to 24 hours) after resumption of therapy. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion of effexor and sunburn 2-sided p-value ≤ 0.05) suggested a dose-dependency for several adverse events in this list, including chills, hypertension, anorexia, nausea, agitation, dizziness, somnolence, tremor, yawning, sweating, and abnormal ejaculation.
TABLE 3 Treatment-Emergent Adverse Experience Incidence in a Dose Comparison Trial
Effexor (mg/day)
Body System/ Preferred Term
Placebo (n=92)
75 (n=89)
225 (n=89)
375 (n=88)
Body as a Whole
Abdominal pain
3.3%
3.4%
2.2%
8.0%
Asthenia
3.3%
16.9%
14.6%
14.8%
Chills
1.1%
2.2%
5.6%
6.8%
Infection
2.2%
2.2%
5.6%
2.3%
Cardiovascular System
Hypertension
1.1%
1.1%
2.2%
4.5%
Vasodilatation
0.0%
4.5%
5.6%
2.3%
Digestive System
Anorexia
2.2%
14.6%
13.5%
17.0%
Dyspepsia
2.2%
6.7%
6.7%
4.5%
Nausea
14.1%
32.6%
38.2%
58.0%
Vomiting
1.1%
7.9%
3.4%
6.8%
Nervous System
Agitation
0.0%
1.1%
2.2%
4.5%
Anxiety
4.3%
11.2%
4.5%
2.3%
Dizziness
4.3%
19.1%
22.5%
23.9%
Insomnia
9.8%
22.5%
20.2%
13.6%
Libido decreased
1.1%
2.2%
1.1%
5.7%
Nervousness
4.3%
21.3%
13.5%
12.5%
Somnolence
4.3%
16.9%
18.0%
26.1%
Tremor
0.0%
1.1%
2.2%
10.2%
Respiratory System
Yawn
0.0%
4.5%
5.6%
8.0%
Skin and Appendages
Sweating
5.4%
6.7%
12.4%
19.3%
Special Senses
Abnormality of accommodation
0.0%
9.1%
7.9%
5.6%
Urogenital System
Abnormal ejaculation/orgasm
0.0%
4.5%
2.2%
12.5%
Impotence
0.0%
5.8%
2.1%
3.6%
(Number of men)
(n=63)
(n=52)
(n=48)
(n=56)
Adaptation to Certain Adverse Events
Over a 6-week period, there was evidence effexor and sunburn adaptation to some adverse events with continued therapy (eg, dizziness and nausea), but less to other effects (eg, abnormal ejaculation and dry mouth).
Vital Sign Changes
Effexor (venlafaxine hydrochloride) treatment (averaged over all dose groups) in clinical trials was associated with a mean increase in pulse rate of approximately effexor and sunburn beats per minute, compared to no change for placebo. In all cases, hair re- growth occurred within 2 to 4 weeks following discontinuation of venlafaxine.
Dermatologic side effects have included sweating in up to approximately 14% of treated patients. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. Following discontinuation of venlafaxine, symptoms resolved within approximately 72 hours. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The reported incidence of each of these effects ranges between 10% and 20% of treated patients. Although these events occurred effexor and sunburn treatment with venlafaxine, causality has not been determined.
There have been a minimum of approximately fifteen cases of hyponatremia in which at least one was life threatening, including at least one case of recurrent venlafaxine- induced hyponatremia after rechallenge.
A recent short-term study (6 weeks) has reported an average weight loss of 2 to effexor and sunburn pounds in patients treated with venlafaxine.
Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (SSRI). There have been postmarketing reports of toxic epidermal necrolysis.
One case of venlafaxine-induced Stevens-Johnson syndrome has been reported. 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% effexor and sunburn venlafaxine-treated patients and 0.0% of placebo-treated patients.
ECG Changes
In an analysis of ECGs obtained in 769 patients treated with Effexor and 450 patients treated with placebo in controlled effexor and sunburn trials, the only statistically significant difference observed was for heart rate, ie, a mean effexor and sunburn from baseline of 4 beats per minute for Effexor.
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